Back to resultsAn Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)
Exclusion Criteria:
- Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
- Have a known hypersensitivity to baricitinib or any component of this investigational product
- Had investigational product permanently discontinued at any time during a previous baricitinib study
- Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
- Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Sites / Locations
- Arizona Arthritis & Rheumatology Research, PLLC
- Arizona Arthritis & Rheumatology Associates, P. C.
- Sun Valley Arthritis Center, LTD
- Arizona Research Center
- University of Arizona
- Valley Endocrine, Fresno
- Allergy and Rheumatology Medical Clinic Inc
- Desert Medical Advances
- Stanford University Hospital
- Pacific Arthritis Center
- Inland Rheumatology & Osteoporosis Medical Group
- Boulder Medical Center
- Denver Arthritis Clinic - Lowry
- New England Research Associates
- Clinical Research Center of CT/NY
- Delaware Arthritis
- Orthopedic Research Institute
- Medallion Clinical Research Institute
- Sun Coast Clinical Research, Inc
- Omega Research Consultants
- Rheumatology Associates of Central Florida
- Arthritis Research of Florida
- West Broward Rheumatology Associates, Inc
- AdventHealth Medical Group
- Tampa Medical Group, P.A.
- Intermountain Research Center
- Deerbrook Medical Associates
- Indiana University Health
- Diagnostic Rheumatology and Research
- Goldpoint Clinical Research LLC
- Klein and Associates MD, PA
- West Michigan Rheumatology
- Borgess Rheumatology
- Advanced Rheumatology, PC
- Office: Dr. Fiechtner, Justus
- Arthritis and Osteporosis Treatment and Research Center
- University of Missouri
- Clayton Medical Research
- Arthritis Consultants, Inc.
- Dr. George Timothy Kelly
- (AOA) Arthritis & Osteoporosis Associates
- Ocean Rheumatology, PA
- Albuquerque Clinical Trials, Inc.
- The Center for Rheumatology
- Drug Trials of America
- Allergy Asthma Immunology of Rochester, AAIR Research Ctr
- Asheville Rheumatology & Osteoporosis Research Assoc, PA
- Arthritis and Osteoporosis Consultants of the Carolinas
- Paramount Medical Research
- Health Research of Oklahoma
- Healthcare Research Consultant
- Oregon Health and Science University
- East Penn Rheumatology Associates
- Altoona Center For Clinical Research
- Arthritis Group
- Clinical Research Center of Reading,LLC
- Carolina Rheumatology and Neurology Associates
- Pioneer Research Solutions
- Metroplex Clinical Research Center
- Accurate Clinical Research
- Arthritis & Osteoporosis Associates LLP
- Accurate Clinical Research
- Center for Arthritis and Rheumatic Diseases, PC
- Western Washington Arthritis Clinic
- Kadlec Clinic Rheumatology
- The Vancouver Clinic
- Rheumatology and Immunotherapy Center
- Hospital Italiano Regional del Sur
- Atencion Integral en Reumatología
- Instituto de Investigaciones Clínicas Mar del Plata
- Centro de Investigaciones Medicas Mar del Plata
- CER Instituto Medico
- Instituto de Investigaciones Clinicas Quilmes
- Instituto Medico de Alta Complejidad San Isidro
- CENIT Centro de Neurociencias, Investigación y Tratamiento
- Instituto Centenario
- Centro de Enfermedades del Higado y Aparato Digestivo
- Instituto CAICI SRL
- CIR Centro de Investigacions Reumatologicas
- Centro Medico Privado de Reumatologia
- Consultorios Asociados de Endocrinologia
- Organizacion Medica de Investigacion - OMI
- Centro De Osteopatias - Comlit
- Hospital Ramos Mejia
- Centro de Medicina Familiar Mindout Research
- Consultorios Reumatologicos Pampa
- CCBR Buenos Aires
- CEMIC Saavedra
- CENUDIAB
- Instituto Medico Strusberg
- Hospital Italiano de Cordoba
- Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
- Hospital Privado Centro Medico de Cordoba SA
- Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
- Canberra Hospital
- Royal Prince Alfred Hospital
- Combined Rheumatology Practice (CRP)
- Coast Joint Care
- Emeritus Research
- St Vincents Hospital Melbourne
- Universitätsklinikum Graz
- Rheuma Zentrum Favoriten GmbH
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Gent
- ZNA Jan Palfijn
- Reuma Clinic, Locatie Jaarbeurslaan
- CHU Ambroise Pare
- CPCLIN
- CEPIC - Centro Paulista de Investigação Clínica
- Associacao de Assistencia a Crianca Deficiente (AACD)
- Rheumatology Research Associates Group
- The Medical Arts Health Research Group
- PerCuro Clinical Research Ltd.
- Manitoba Clinic Medical Corporation
- KW Musculoskeletal Research Inc
- The Ottawa Hospital
- Niagara Peninsula Arthritis Centre, Inc.
- UHN-Toronto Western Hospital
- Mount Sinai Hospital
- Center de Recherche St Louis
- Centre de Recherche Musculo-Squelettique
- Saskatoon Osteoporosis Centre
- Afflilated Hospital of Bengbu Medical College
- Anhui Provincial Hospital
- The First Affiliate Hospital of AnHui Medical University
- Peking University People's Hospital
- Guangdong Provincial People's Hospital
- 1st Hospital affiliated to Medical College of Shantou Univer
- Xiangya Hospital, Central South University
- The Second Xiangya Hospital of Central South University
- ZhuZhou Central Hospital
- YanCheng First People's Hospital
- Pingxiang People's Hospital
- Qilu Hospital of Shandong University
- Zhongshan Hospital, Fudan University
- West China Hospital Sichuan University
- First Affiliated Hospital of Kunming Medical University
- Ningbo First Hospital
- China-Japan Friendship Hospital
- Shanghai Guanghua Hospital
- KBC Osijek
- Klinicka bolnica Sveti Duh
- Poliklinika K-centar
- Revmatologicky ustav
- Revmaclinic, s.r.o
- Revmatologicka ambulance
- ELIMATES BRNO s.r.o. Revmatologicka ambulance
- Vesalion s.r.o.
- Artroscan, s.r.o.
- ARTHROHELP s.r.o.
- Medical Plus
- PV Medical Services s.r.o.
- Frederiksberg Hospital
- Copenhagen University Hospital
- Odense Universitetshospital
- CHRU de Limoges Hopital Dupuytren
- Centre Hospitalier Jean Rougier
- Hôpital Trousseau, CHRU de Tours
- Hôpital Arnaud de Villeneuve - CHU Montpellier
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
- Nouvel Hôpital Orléans La Source
- Hopital de la Pitie Salpetriere
- Hopital Cochin
- CHU la Miletrie
- CHU Rennes/Hopital Sud
- Hopital Bel Air
- Universitätsklinikum Heidelberg
- Internistisch-rheumatologische Praxisgemeinschaft Bayreuth
- Klinikum der Universität München
- Universitätsklinikum Würzburg A. ö. R.
- Universitätsklinikum Köln
- Immunologisches Zentrum Vogelsang-Gommern GmbH
- Städtisches Klinikum Dresden-Friedrichstadt
- Charité Campus Virchow-Klinikum
- Schön Klinik Hamburg Eilbek
- Hippokration Hospital of Athens
- General Hospital of Attica KAT
- University General Hospital of Heraklion
- University General Hospital of Larissa
- Kiskunhalasi Semmelweis Korhaz
- Dr. Rethy Pal Korhaz es Rendelointezet
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Revita Clinic
- Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz
- Orszagos Reumatologiai es Fizioterapias Intezet
- Csolnoky Ferenc Korhaz
- Sumana Hospital
- Sir Ganga Ram Hospital
- Indraprastha Apollo Hospital
- Shalby Hospital
- Medanta-The Medicity
- Manipal Centre for Clinical Research (MCCR)
- St. John Medical College & Hospital
- M S Ramaiah Medical College Hospital
- KLES Prabhakar Kore Hospital and Medical Research Centre
- Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
- Shri Nidan Hospital & Hope Fertility Centre
- Care Hospital
- Krishna Institute of Medical Sciences Ltd.
- CSM Medical University
- IPGMER and SSKM Hospital
- Apollo Gleneagles Hospitals Kolkata
- Barzilai Medical Center
- Bnai Zion Medical Center
- Rambam Health Care Campus
- Hadassah Medical Center
- Meir Medical Center
- Rabin Medical Center
- Tel Aviv Sourasky Medical Center
- Assaf Harofeh Medical Center
- Carmel Hospital
- Azienda Ospedaliera Universitaria Careggi
- Ospedale Luigi Sacco
- Stabilimento Ospedaliero Santa Chiara
- Polic.Umberto I -Univ. La Sapienza
- Ospedale San Giovanni Bosco
- Ospedale Policlinico Giambattista Rossi, Borgo Roma
- Chubu-Rosai Hospital
- Nagoya Medical Center
- Nagoya University Hospital
- National Chiba-East-Hospital
- Matsudo City Hospital
- Chibaken Saiseikai Narashino Hospital
- Shimoshizu National Hospital
- PS Clinic
- Aso Iizuka Hospital
- University of Occupational and Enviromental Health
- National Hospital Organization Asahikawa Medical Center
- Katayama Clinic
- Sagawa Akira Rheumatology Clinic
- NTT East Japan Sapporo Hospital
- Hokkaido University Hospital
- Hokkaido Medical Center for Rheumatic Diseases
- Matsubara Mayflower Hospital
- Takarazuka City Hospital
- Oasis Clinic
- Tsukuba University Hospital
- Yoshida Orthopaedic and Rheumatic Clinic
- Komagamine Orthopedic and Rheumatology Clinic
- Kagawa University Hospital
- Yoshitama Clinic Rheumatology & Internal Medicine
- Tokai University Hospital
- St Marianna University School of Medicine Hospital
- Tsuzuki Azuma Clinic: Primary care and Rheumatology
- Yokohama Rosai Hospital
- Yokohama City University Hospital
- Yokohama Minami Kyosai Hospital
- Kumamoto Saishun Medical Center
- Yokkaichi Hazu Medical Center
- National Nagasaki Medical Center
- Sasebo Chuo Hospital
- Nagaoka Red Cross Hospital
- Niigata Rheumatic Center
- Osafune Clinic
- Tomishiro Central Hospital
- NHO Ureshino Medical Center
- Saitama Medical Center
- Kaneko Clinic
- Azuma Rheumatology Clinic
- Hirose Clinic
- Seirei Hamamatsu General Hospital
- Jichi Medical University Hospital
- Tokyo Women's Medical University East Medical Center
- St. Lukes International Hospital
- Fujimori Clinic
- Nihon University Itabashi Hospital
- National Tokyo Medical Center
- Kyorin University Hospital
- Keio University Hospital
- Takaoka Rheumatic Orthopedic CL
- Miyasato Clinic
- National Hospital Organization Kyushu Medical Center
- Kondo Clinic for Rheumatism and Orthopaedics
- Medical Co. LTA Fukuoka Mirai Hospital
- Shono Rheumatism Clinic
- Hiroshima Rheumatology Clinic
- Hiroshima Clinic
- Kagoshima Red Cross Hospital
- Kumamoto Rheumatology Clinic
- Kumamoto Orthopedic Hospital
- Kumamoto Shinto General hospital
- Nagano Red Cross Hospital
- Nagasaki Medical Hospital of Rheumatology
- The Japanese Red Cross Nagasaki Genbaku Hospital
- Oribe Clinic Rheumatism and Medicine
- Okayama Saiseikai General Hospital Outpatient Center
- Okayama University Hospital
- Japanese Red Cross Okayama Hospital
- Yokota Clinic for Rheumatology
- Shizuoka Rheumatism orthopedic Rehabilitation Hospital
- JA-Shizuoka Shizuoka-Kosei General Hospital
- Ajou University Hospital
- Chungnam National University Hospital
- Kyung Pook National University Hospital
- Daegu Catholic University Medical Center
- Chungnam National University Hospital
- Chonnam National University Hospital
- Gachon University Gil Medical Center
- Inha University Hospital
- Kyung Hee University Hospital
- Seoul National University Hospital
- Hanyang University Medical Center
- Kyunghee University Hospital at Gangdong
- Asan Medical Center
- Seoul St. Mary's Hospital
- Seoul Municipal Boramae Hospital
- Catholic University of Korea Yeouido St. Mary's Hospital
- Konkuk University Medical Center
- Rheumatology Practice in Jaunliepaja Primary Health Care Cen
- Pauls Stradins Kliniska Universitates Slimnica
- Dr. Sarmite Saleniece
- Dr. Kildos Klinika
- Klaipedos Universitetine Ligonine
- Respublikine Siauliu Ligonine
- Ctro Inv en Artritis y Osteoporosis SC
- Centro de Investigacion del Noroeste
- Mexico Centre for Clinical Research SA de CV
- RM Pharma Specialists S.A. de C.V.
- Hospital de Jesus I.A.P.
- Comite Mexicano para la Prevencion de la Osteoporosis A.C.
- Mentrials S.A. de C.V
- Centro Integral en Reumatologia SA de CV
- Unidad de Investigacion en Enfermedades Cronico Degenerative
- Clinica de Investigacion en Reumatologia y Obesidad S. C.
- Private Service
- Centro de Estudios de Investigacion Basica y Clinica, S.C.
- Hospital Universitario de Monterrey
- Centro Medico de las Americas
- Medical Care and Research, S.A. de C.V.
- Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
- Ziekenhuisgroep Twente, Almelo
- Centrum Badan Klinicznych PI-House sp. z o.o.
- Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
- Ambulatorium Barbara Bazela
- Centrum Medyczne Pratia Katowice
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
- NZOZ Lecznica MAK-MED s.c.
- REUMATIKA - Centrum Reumatologii
- Centrum Medyczne AMED
- Hospital Garcia da Orta
- Instituto Portugues de Reumatologia
- Hospital do Conde de Bertiandos
- Hospital Geral de Santo Antonio
- Hospital de Sao Joao E.P.E.
- Ramon L. Ortega Colon
- Ponce School of Medicine CAIMED Center
- Latin Clinical Trial Center
- Mindful Medical Research
- Barbara Diaz Hernandez
- Spital Clinic Judetean de Urgenta Tg.Mures
- SC DUO Medical S.R.L Rheumatology
- Spitalul Clinic Sf Maria Bucuresti
- Spitalul Clinic "Dr. Ioan Cantacuzino"
- Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
- Spitalul Clinic de Recuperare Iasi
- Gbuz Lokb
- GUZ UOKB
- Family Clinic No 4
- V.A. Nasonova Research Institute of Rheumatology
- City Clinical Hospital 1 named after N.I. Pirogov
- First Moscow State Medical University
- Ryazan Regional Clinincal Cardiology Dispensary
- Saratov Regional Clinical Hospital
- Clinical Rheumatology Hospital # 25
- Clinical Emergency Hospital N.V.Solovyov
- Nestatna reumatologicka ambulancia
- ROMJAN s.r.o.
- Reumacentrum s.r.o.
- REUMED s.r.o.
- LERAM s.r.o.
- Bolnisnica Dr. P. Drzaja UKCLJ
- Netcare Greenacres Hospital
- Saint Augustine's Hospital
- Precise Clinical Solutions (Pty) Ltd
- Arthritis Clinical Trial Centre
- Somerset West Trial Centre
- Winelands Medical Research Centre
- Hospital Marina Baixa
- Hospital Quiron Infanta Luisa
- Corporacion Sanitaria Parc Tauli
- Hospital Universitario Marques De Valdecilla
- Hospital Universitario Getafe
- Hospital De Basurto
- Hospital de la Santa Creu i Sant Pau
- Hospital Clinic I Provincial
- Hospital Universitario Virgen Macarena
- Hospital Universitario La Fe de Valencia
- Sahlgrenska Universitetssjukhuset
- Reumatologiska Kliniken Skånes universitetssjukhus Malmö
- CHUV Centre Hospitalier Universitaire Vaudois
- HFR Fribourg - Hôpital Cantonal
- Universitätsspital Zürich
- Chang Gung Memorial Hospital - Kaohsiung Branch
- Tri-Service General Hospital
- Chung Shan Medical University Hospital
- China Medical University Hospital
- National Taiwan University Hospital
- MacKay Memorial Hospital
- Cathay General Hospital
- Taipei Veterans General Hospital
- Chi-Mei Medical Center
- Trakya University
- Addenbrookes Hospital
- Basingstoke and North Hampshire Hospital
- Southampton General Hospital
- Whipps Cross University Hospital
- Guy's Hospital
- Northumbria Healthcare NHS Foundation Trust
- St Lukes Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
4 milligram (mg) Baricitinib
2 mg Baricitinib
2 mg Baricitinib Step-down
4 mg Baricitinib Step-down
Arm Description
4 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
2 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
2 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
4 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Outcomes
Primary Outcome Measures
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%.
An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Secondary Outcome Measures
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Percentage of Participants With mTSS Change ≤0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Percentage of Participants With mTSS Change ≤0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Percentage of Participants With mTSS Change ≤0
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing
Change From Baseline of Originating Study in Duration of Morning Stiffness
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Change From Baseline of Originating Study in Duration of Morning Stiffness
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Change From Baseline of Originating Study in Duration of Morning Stiffness
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Change From Baseline of Originating Study in Bone Erosion Score
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet).
Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Change From Baseline of Originating Study in Bone Erosion Score
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Change From Baseline of Originating Study in Bone Erosion Score
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Healthcare Resource Utilization
Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period
Relapse is defined as a Clinical Disease Activity Index score > 10. The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
Total number of participants at risk multiplied by estimate of cumulative event probability would need to be rounded up or down to get a whole number.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01885078
Brief Title
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Acronym
RA-BEYOND
Official Title
A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2013 (Actual)
Primary Completion Date
November 12, 2020 (Actual)
Study Completion Date
November 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.
The study provides 7 years of additional treatment with baricitinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2877 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 milligram (mg) Baricitinib
Arm Type
Experimental
Arm Description
4 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Arm Title
2 mg Baricitinib
Arm Type
Experimental
Arm Description
2 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Arm Title
2 mg Baricitinib Step-down
Arm Type
Experimental
Arm Description
2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Arm Title
4 mg Baricitinib Step-down
Arm Type
Experimental
Arm Description
4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY 3009104, INCB 028050
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%.
An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Time Frame
Baseline through 84 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Description
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Description
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Description
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Description
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Description
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Description
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Description
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Description
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Description
ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Description
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Description
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Description
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Description
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Description
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Description
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Description
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Description
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Description
Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame
Year 5 after entry into JADY
Title
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Description
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame
Baseline, Year 1
Title
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Description
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame
Baseline, Year 3
Title
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Description
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame
Baseline, Year 5
Title
Percentage of Participants With mTSS Change ≤0
Description
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants With mTSS Change ≤0
Description
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants With mTSS Change ≤0
Description
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame
Year 5 after entry into JADY
Title
Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
Description
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Time Frame
Baseline, Year 1
Title
Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
Description
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Time Frame
Baseline, Year 3
Title
Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
Description
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing
Time Frame
Baseline, Year 5
Title
Change From Baseline of Originating Study in Duration of Morning Stiffness
Description
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame
Baseline, Year 1
Title
Change From Baseline of Originating Study in Duration of Morning Stiffness
Description
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame
Baseline, Year 3
Title
Change From Baseline of Originating Study in Duration of Morning Stiffness
Description
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame
Baseline, Year 5
Title
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Description
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame
Baseline, Year 1
Title
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Description
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame
Baseline, Year 3
Title
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Description
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame
Baseline, Year 5
Title
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame
Baseline, Year 1
Title
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame
Baseline, Year 3
Title
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description
The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame
Baseline, Year 5
Title
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Description
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Description
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Description
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame
Years 5 after entry into JADY
Title
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8
Description
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Description
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Description
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Description
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame
Year 5 after entry into JADY
Title
Change From Baseline of Originating Study in Bone Erosion Score
Description
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet).
Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Time Frame
Baseline, Year 1
Title
Change From Baseline of Originating Study in Bone Erosion Score
Description
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Time Frame
Baseline, Year 3
Title
Change From Baseline of Originating Study in Bone Erosion Score
Description
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion.
LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Time Frame
Baseline, Year 5
Title
Healthcare Resource Utilization
Description
Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY.
Time Frame
Baseline up to 84 Months
Title
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Description
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Description
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Description
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Description
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Time Frame
Year 1 after entry into JADY
Title
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Description
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Time Frame
Year 3 after entry into JADY
Title
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Description
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Time Frame
Year 5 after entry into JADY
Title
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period
Description
Relapse is defined as a Clinical Disease Activity Index score > 10. The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
Total number of participants at risk multiplied by estimate of cumulative event probability would need to be rounded up or down to get a whole number.
Time Frame
Week 0 through Week 96 of Step-down
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)
Exclusion Criteria:
Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
Have a known hypersensitivity to baricitinib or any component of this investigational product
Had investigational product permanently discontinued at any time during a previous baricitinib study
Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P. C.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Sun Valley Arthritis Center, LTD
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Valley Endocrine, Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Allergy and Rheumatology Medical Clinic Inc
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Pacific Arthritis Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Inland Rheumatology & Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Boulder Medical Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Denver Arthritis Clinic - Lowry
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
New England Research Associates
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Clinical Research Center of CT/NY
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Delaware Arthritis
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Medallion Clinical Research Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Sun Coast Clinical Research, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Arthritis Research of Florida
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
West Broward Rheumatology Associates, Inc
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
AdventHealth Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Intermountain Research Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Deerbrook Medical Associates
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Diagnostic Rheumatology and Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Goldpoint Clinical Research LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Klein and Associates MD, PA
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
West Michigan Rheumatology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Borgess Rheumatology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Advanced Rheumatology, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Office: Dr. Fiechtner, Justus
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Arthritis and Osteporosis Treatment and Research Center
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Clayton Medical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Arthritis Consultants, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dr. George Timothy Kelly
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
(AOA) Arthritis & Osteoporosis Associates
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Ocean Rheumatology, PA
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Drug Trials of America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Allergy Asthma Immunology of Rochester, AAIR Research Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Asheville Rheumatology & Osteoporosis Research Assoc, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Arthritis and Osteoporosis Consultants of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Healthcare Research Consultant
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
East Penn Rheumatology Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Clinical Research Center of Reading,LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Carolina Rheumatology and Neurology Associates
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Pioneer Research Solutions
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Accurate Clinical Research
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Arthritis & Osteoporosis Associates LLP
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Accurate Clinical Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Center for Arthritis and Rheumatic Diseases, PC
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Western Washington Arthritis Clinic
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Facility Name
Kadlec Clinic Rheumatology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
The Vancouver Clinic
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Rheumatology and Immunotherapy Center
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Hospital Italiano Regional del Sur
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
B8000HXM
Country
Argentina
Facility Name
Atencion Integral en Reumatología
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1426AAL
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
CER Instituto Medico
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVC
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Quilmes
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Instituto Medico de Alta Complejidad San Isidro
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
B1642
Country
Argentina
Facility Name
CENIT Centro de Neurociencias, Investigación y Tratamiento
City
Caba
State/Province
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Instituto Centenario
City
Caba
State/Province
Ciudad Autonoma De Buenos Aire
ZIP/Postal Code
1204
Country
Argentina
Facility Name
Centro de Enfermedades del Higado y Aparato Digestivo
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CFJ
Country
Argentina
Facility Name
Instituto CAICI SRL
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000
Country
Argentina
Facility Name
CIR Centro de Investigacions Reumatologicas
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000BRD
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Consultorios Asociados de Endocrinologia
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Organizacion Medica de Investigacion - OMI
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Centro De Osteopatias - Comlit
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Hospital Ramos Mejia
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Centro de Medicina Familiar Mindout Research
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1417EYG
Country
Argentina
Facility Name
Consultorios Reumatologicos Pampa
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1428DZF
Country
Argentina
Facility Name
CCBR Buenos Aires
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1430CKE
Country
Argentina
Facility Name
CEMIC Saavedra
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
CENUDIAB
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Instituto Medico Strusberg
City
Cordoba
ZIP/Postal Code
X5000EDC
Country
Argentina
Facility Name
Hospital Italiano de Cordoba
City
Cordoba
ZIP/Postal Code
X5004BAK
Country
Argentina
Facility Name
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba SA
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Combined Rheumatology Practice (CRP)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Coast Joint Care
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Universitätsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Rheuma Zentrum Favoriten GmbH
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
State/Province
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
State/Province
Vlaams Gewest
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Reuma Clinic, Locatie Jaarbeurslaan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
CHU Ambroise Pare
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
CPCLIN
City
São Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica
City
São Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Associacao de Assistencia a Crianca Deficiente (AACD)
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Rheumatology Research Associates Group
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
The Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Manitoba Clinic Medical Corporation
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
KW Musculoskeletal Research Inc
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Niagara Peninsula Arthritis Centre, Inc.
City
St. Catherines
State/Province
Ontario
ZIP/Postal Code
L2N 7E4
Country
Canada
Facility Name
UHN-Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Center de Recherche St Louis
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Saskatoon Osteoporosis Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Afflilated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliate Hospital of AnHui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
1st Hospital affiliated to Medical College of Shantou Univer
City
Shantou
State/Province
Guangzhou
ZIP/Postal Code
515041
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
ZhuZhou Central Hospital
City
ZhuZhou
State/Province
Hunan
ZIP/Postal Code
412007
Country
China
Facility Name
YanCheng First People's Hospital
City
Yancheng
State/Province
Jiangsu
ZIP/Postal Code
224005
Country
China
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Shanghai Guanghua Hospital
City
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
KBC Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicka bolnica Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika K-centar
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Revmatologicky ustav
City
Praha 2
State/Province
Praha, Hlavní Mešto
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Revmaclinic, s.r.o
City
Brno
ZIP/Postal Code
611 41
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Bruntal
ZIP/Postal Code
792 01
Country
Czechia
Facility Name
ELIMATES BRNO s.r.o. Revmatologicka ambulance
City
Hustopece
ZIP/Postal Code
693 01
Country
Czechia
Facility Name
Vesalion s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Artroscan, s.r.o.
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
ARTHROHELP s.r.o.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Medical Plus
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
PV Medical Services s.r.o.
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Frederiksberg Hospital
City
Frederiksberg
State/Province
Hovedstaden
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Copenhagen University Hospital
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
State/Province
Syd
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHRU de Limoges Hopital Dupuytren
City
Limoges CEDEX
State/Province
Haute-Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier Jean Rougier
City
Cahors CEDEX 9
ZIP/Postal Code
46005
Country
France
Facility Name
Hôpital Trousseau, CHRU de Tours
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Hôpital Arnaud de Villeneuve - CHU Montpellier
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Nouvel Hôpital Orléans La Source
City
Orleans CEDEX 2
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital de la Pitie Salpetriere
City
Paris CEDEX 13
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Cochin
City
Paris CEDEX 14
ZIP/Postal Code
75679
Country
France
Facility Name
CHU la Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU Rennes/Hopital Sud
City
Rennes CEDEX 2
ZIP/Postal Code
35056
Country
France
Facility Name
Hopital Bel Air
City
Thionville
ZIP/Postal Code
57100
Country
France
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Internistisch-rheumatologische Praxisgemeinschaft Bayreuth
City
Bayreuth
State/Province
Bayern
ZIP/Postal Code
95444
Country
Germany
Facility Name
Klinikum der Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitätsklinikum Würzburg A. ö. R.
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Immunologisches Zentrum Vogelsang-Gommern GmbH
City
Gommern
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39245
Country
Germany
Facility Name
Städtisches Klinikum Dresden-Friedrichstadt
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Schön Klinik Hamburg Eilbek
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Hippokration Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Attica KAT
City
Kifissia
State/Province
Attiki
ZIP/Postal Code
14561
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Kiskunhalasi Semmelweis Korhaz
City
Kiskunhalas
State/Province
Bacs-Kiskun
ZIP/Postal Code
6400
Country
Hungary
Facility Name
Dr. Rethy Pal Korhaz es Rendelointezet
City
Bekescsaba
State/Province
Bekes
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Revita Clinic
City
Budapest
State/Province
Pest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Orszagos Reumatologiai es Fizioterapias Intezet
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Sumana Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500072
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Shalby Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Medanta-The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Manipal Centre for Clinical Research (MCCR)
City
Attavar, Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
St. John Medical College & Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
M S Ramaiah Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
KLES Prabhakar Kore Hospital and Medical Research Centre
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400053
Country
India
Facility Name
Shri Nidan Hospital & Hope Fertility Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Care Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Krishna Institute of Medical Sciences Ltd.
City
Secunderabad
State/Province
Telengana
ZIP/Postal Code
500003
Country
India
Facility Name
CSM Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226018
Country
India
Facility Name
IPGMER and SSKM Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Apollo Gleneagles Hospitals Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
State/Province
HaDarom
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3525406
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Carmel Hospital
City
Haifa
State/Province
Ḥeifā
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Stabilimento Ospedaliero Santa Chiara
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Polic.Umberto I -Univ. La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale San Giovanni Bosco
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Ospedale Policlinico Giambattista Rossi, Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Chubu-Rosai Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Chiba-East-Hospital
City
Chuo-ku
State/Province
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Matsudo City Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
271-8511
Country
Japan
Facility Name
Chibaken Saiseikai Narashino Hospital
City
Narashino
State/Province
Chiba
ZIP/Postal Code
275-8580
Country
Japan
Facility Name
Shimoshizu National Hospital
City
Yotsukaido
State/Province
Chiba
ZIP/Postal Code
284-0003
Country
Japan
Facility Name
PS Clinic
City
Hakata-ku
State/Province
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Aso Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
University of Occupational and Enviromental Health
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Katayama Clinic
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Facility Name
Sagawa Akira Rheumatology Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
NTT East Japan Sapporo Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hokkaido Medical Center for Rheumatic Diseases
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0811
Country
Japan
Facility Name
Matsubara Mayflower Hospital
City
Kato
State/Province
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Takarazuka City Hospital
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Facility Name
Oasis Clinic
City
Hitachi
State/Province
Ibaragi
ZIP/Postal Code
316-0015
Country
Japan
Facility Name
Tsukuba University Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Yoshida Orthopaedic and Rheumatic Clinic
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0015
Country
Japan
Facility Name
Komagamine Orthopedic and Rheumatology Clinic
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0034
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Yoshitama Clinic Rheumatology & Internal Medicine
City
Kirishima
State/Province
Kagoshima
ZIP/Postal Code
899-5117
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
St Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Tsuzuki Azuma Clinic: Primary care and Rheumatology
City
Yokohama-City
State/Province
Kanagawa
ZIP/Postal Code
224-0041
Country
Japan
Facility Name
Yokohama Rosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Yokohama Minami Kyosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0037
Country
Japan
Facility Name
Kumamoto Saishun Medical Center
City
Koshi
State/Province
Kumamoto
ZIP/Postal Code
861-1196
Country
Japan
Facility Name
Yokkaichi Hazu Medical Center
City
Yokkaichi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
National Nagasaki Medical Center
City
Omura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Sasebo Chuo Hospital
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Niigata Rheumatic Center
City
Shibata
State/Province
Niigata
ZIP/Postal Code
957-0054
Country
Japan
Facility Name
Osafune Clinic
City
Setouchi
State/Province
Okayama
ZIP/Postal Code
701-4264
Country
Japan
Facility Name
Tomishiro Central Hospital
City
Tomigusuku
State/Province
Okinawa
ZIP/Postal Code
901-0243
Country
Japan
Facility Name
NHO Ureshino Medical Center
City
Ureshino
State/Province
Saga
ZIP/Postal Code
843 0301
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Kaneko Clinic
City
Kawaguchi
State/Province
Saitama
ZIP/Postal Code
333-0833
Country
Japan
Facility Name
Azuma Rheumatology Clinic
City
Sayama
State/Province
Saitama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
Hirose Clinic
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1111
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo Women's Medical University East Medical Center
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-8567
Country
Japan
Facility Name
St. Lukes International Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104 8560
Country
Japan
Facility Name
Fujimori Clinic
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0931
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
National Tokyo Medical Center
City
Meguro-Ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Takaoka Rheumatic Orthopedic CL
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-0874
Country
Japan
Facility Name
Miyasato Clinic
City
Shunan
State/Province
Yamaguchi
ZIP/Postal Code
745-0824
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810 8563
Country
Japan
Facility Name
Kondo Clinic for Rheumatism and Orthopaedics
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Medical Co. LTA Fukuoka Mirai Hospital
City
Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
Shono Rheumatism Clinic
City
Fukuoka
ZIP/Postal Code
814-0002
Country
Japan
Facility Name
Hiroshima Rheumatology Clinic
City
Hiroshima
ZIP/Postal Code
730-0017
Country
Japan
Facility Name
Hiroshima Clinic
City
Hiroshima
ZIP/Postal Code
733-0032
Country
Japan
Facility Name
Kagoshima Red Cross Hospital
City
Kagoshima
ZIP/Postal Code
891-0133
Country
Japan
Facility Name
Kumamoto Rheumatology Clinic
City
Kumamoto
ZIP/Postal Code
861-5515
Country
Japan
Facility Name
Kumamoto Orthopedic Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Kumamoto Shinto General hospital
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
Nagano Red Cross Hospital
City
Nagano
ZIP/Postal Code
380-8582
Country
Japan
Facility Name
Nagasaki Medical Hospital of Rheumatology
City
Nagasaki
ZIP/Postal Code
850-0832
Country
Japan
Facility Name
The Japanese Red Cross Nagasaki Genbaku Hospital
City
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Facility Name
Oribe Clinic Rheumatism and Medicine
City
Oita
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Okayama Saiseikai General Hospital Outpatient Center
City
Okayama
ZIP/Postal Code
700-0013
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital
City
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Yokota Clinic for Rheumatology
City
Osaka
ZIP/Postal Code
545-0011
Country
Japan
Facility Name
Shizuoka Rheumatism orthopedic Rehabilitation Hospital
City
Shizuoka
ZIP/Postal Code
420-0821
Country
Japan
Facility Name
JA-Shizuoka Shizuoka-Kosei General Hospital
City
Shizuoka
ZIP/Postal Code
420-8623
Country
Japan
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Dae Jeon
State/Province
Korea
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Kyung Pook National University Hospital
City
Daegu
State/Province
Korea
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
State/Province
Korea
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Korea
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Korea
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Korea
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
State/Province
Korea
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital at Gangdong
City
Seoul
State/Province
Korea
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Seoul Municipal Boramae Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Catholic University of Korea Yeouido St. Mary's Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Rheumatology Practice in Jaunliepaja Primary Health Care Cen
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
Pauls Stradins Kliniska Universitates Slimnica
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Dr. Sarmite Saleniece
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Dr. Kildos Klinika
City
Kaunas
ZIP/Postal Code
LT-50128
Country
Lithuania
Facility Name
Klaipedos Universitetine Ligonine
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Respublikine Siauliu Ligonine
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Ctro Inv en Artritis y Osteoporosis SC
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
Centro de Investigacion del Noroeste
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Mexico Centre for Clinical Research SA de CV
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
RM Pharma Specialists S.A. de C.V.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Hospital de Jesus I.A.P.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Comite Mexicano para la Prevencion de la Osteoporosis A.C.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Mentrials S.A. de C.V
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Centro Integral en Reumatologia SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Unidad de Investigacion en Enfermedades Cronico Degenerative
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S. C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Private Service
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica y Clinica, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Hospital Universitario de Monterrey
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Centro Medico de las Americas
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Medical Care and Research, S.A. de C.V.
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Ziekenhuisgroep Twente, Almelo
City
Almelo
ZIP/Postal Code
7600 SZ
Country
Netherlands
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Ambulatorium Barbara Bazela
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90242
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED s.c.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
REUMATIKA - Centrum Reumatologii
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Hospital Garcia da Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Instituto Portugues de Reumatologia
City
Lisbon
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Hospital do Conde de Bertiandos
City
Ponte de Lima
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital de Sao Joao E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Ramon L. Ortega Colon
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Ponce School of Medicine CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Barbara Diaz Hernandez
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Spital Clinic Judetean de Urgenta Tg.Mures
City
Tg.Mures
State/Province
Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
SC DUO Medical S.R.L Rheumatology
City
Bucuresti
ZIP/Postal Code
010584
Country
Romania
Facility Name
Spitalul Clinic Sf Maria Bucuresti
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic "Dr. Ioan Cantacuzino"
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Spitalul Clinic de Recuperare Iasi
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Gbuz Lokb
City
Saint-Petersburg
State/Province
Leningradskaya Oblast'
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
GUZ UOKB
City
Ul'yanovsk
State/Province
Ul'yanovskaya Oblast
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Family Clinic No 4
City
Korolev
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
V.A. Nasonova Research Institute of Rheumatology
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
City Clinical Hospital 1 named after N.I. Pirogov
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Ryazan Regional Clinincal Cardiology Dispensary
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Saratov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Clinical Rheumatology Hospital # 25
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Clinical Emergency Hospital N.V.Solovyov
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Nestatna reumatologicka ambulancia
City
Bratislava
ZIP/Postal Code
84231
Country
Slovakia
Facility Name
ROMJAN s.r.o.
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Reumacentrum s.r.o.
City
Partizanske
ZIP/Postal Code
958 01
Country
Slovakia
Facility Name
REUMED s.r.o.
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
LERAM s.r.o.
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
Bolnisnica Dr. P. Drzaja UKCLJ
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Netcare Greenacres Hospital
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Saint Augustine's Hospital
City
Durban
State/Province
KZ-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Precise Clinical Solutions (Pty) Ltd
City
Durban
State/Province
KZ-Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Arthritis Clinical Trial Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Somerset West Trial Centre
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hospital Marina Baixa
City
La Vila Joiosa
State/Province
Alicante
ZIP/Postal Code
03570
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41010
Country
Spain
Facility Name
Corporacion Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario Marques De Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital De Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
State/Province
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Reumatologiska Kliniken Skånes universitetssjukhus Malmö
City
Malmo
ZIP/Postal Code
20502
Country
Sweden
Facility Name
CHUV Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
HFR Fribourg - Hôpital Cantonal
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Chang Gung Memorial Hospital - Kaohsiung Branch
City
Kaohsiung City
ZIP/Postal Code
833401
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Neihu Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
MacKay Memorial Hospital
City
Taipei City
ZIP/Postal Code
104217
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei City
ZIP/Postal Code
106438
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112201
Country
Taiwan
Facility Name
Chi-Mei Medical Center
City
Yongkang City
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Basingstoke and North Hampshire Hospital
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hants
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Surrey
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
Surrey
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Newcastle upon Tyne
State/Province
Tyneside
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
St Lukes Hospital
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
34706874
Citation
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
Results Reference
derived
PubMed Identifier
34028703
Citation
Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.
Results Reference
derived
PubMed Identifier
31233281
Citation
Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.
Results Reference
derived
PubMed Identifier
31040122
Citation
Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.
Results Reference
derived
PubMed Identifier
30999933
Citation
Winthrop KL, Bingham CO 3rd, Komocsar WJ, Bradley J, Issa M, Klar R, Kartman CE. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy. Arthritis Res Ther. 2019 Apr 18;21(1):102. doi: 10.1186/s13075-019-1883-1.
Results Reference
derived
PubMed Identifier
30219772
Citation
Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649.
Results Reference
derived
PubMed Identifier
30058112
Citation
Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.
Results Reference
derived
PubMed Identifier
29463520
Citation
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Results Reference
derived
Learn more about this trial
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
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