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A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)

Primary Purpose

Systemic Lupus Erythematosus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).

Sites / Locations

  • Achieve Clinical Research, LLC
  • Arizona Arthritis & Rheumatology Research
  • Arizona Arthritis & Rheumatology Associates, P. C.
  • Wallace Rheumatic Studies Center
  • Medvin Clinical Research - Weidmann
  • Providence Medical Foundation
  • MD Medical Corporation
  • ACRC Studies
  • Inland Rheumatology & Osteoporosis Medical Group
  • Medvin Clinical Research - Weidmann
  • Denver Arthritis Clinic - Lowry
  • New England Research Associates
  • Arthritis and Rheumatic Disease
  • Clinical Research of West Florida, Inc. (Clearwater)
  • Lakes Research, LLC
  • Millennium Research
  • Integral Rheumatology & Immunology Specialists
  • IRIS Research and Development, LLC
  • ForCare Clinical Research
  • Tampa Medical Group, P.A.
  • Piedmont Healthcare
  • Emory University
  • North Georgia Rheumatology, PC
  • Arthritis Center of Lexington
  • Johns Hopkins Asthma and Allergy Center
  • Henry Ford Health System
  • Advanced Rheumatology, PC
  • Clinical Research Institute of Michigan, LLC
  • Glacir View Research Institute
  • Allied Clinical Research
  • Arthritis and Osteoporosis Associates of New Mexico
  • St. Lawrence Health System
  • The Feinstein Institute for Medical Research
  • Columbia University Medical Center
  • NYU Langone
  • SUNY Upstate Medical University
  • Joint and Muscle Medical Care
  • Box Arthritis & Rheumatology of the Carolinas, PLLC
  • Medication Management
  • Cincinnati Rheumatic Disease Study Group
  • Paramount Medical Research
  • Arthritis & Rheumatology Center of Oklahoma PLLC
  • Oklahoma Medical Research Foundation
  • East Penn Rheumatology Associates
  • Clinical Research Center of Reading,LLC
  • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
  • Eagle Medical
  • West Tennessee Research Institute
  • Amarillo Center for Clinical Research
  • Accurate Clinical Management
  • Dr. Dhiman Basu Private Practice
  • Metroplex Clinical Research Center
  • Precision Comprehensive Clinical Research Solutions
  • Rheumatology Center Of Houston
  • Accurate Clinical Research
  • Southwest Rheumatology, P.A.
  • Accurate Clinical Research, Inc.
  • Advanced Rheumatology of Houston
  • Arthritis Clinic of Northern VA, P.C.
  • Spectrum Medical Inc.
  • Rheumatic Disease Center
  • Aprillus Asistencia e Investigacion de Arcis Salud SRL
  • DOM Centro de Reumatologia
  • Framingham Centro Medico
  • CER Instituto Medico
  • Instituto de Investigaciones Clinicas Quilmes
  • Clinica Adventista Belgrano
  • Sanatorio Británico
  • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
  • IR Medical Center S.A. Instituto de Reumatologia
  • Centro de Investigaciones Médicas Tucuman
  • Optimus Clinical Research
  • The Rheumatology Research Unit Sunshine Coast
  • Emeritus Research
  • St. Vincent's Hospital
  • A O Krankenhaus der Elisabethinen
  • Medizinische Universität Graz
  • UZ Leuven
  • Cliniques Universitaires Saint-Luc
  • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
  • Santa Casa de Misericordia de Belo Horizonte
  • Centro de Estudos em Terapias Inovadoras-CETI
  • EDUMED - Educação em Saúde Ltda.
  • LMK Serviços Médicos S/S
  • Hospital de Clinicas UNICAMP
  • Oncovida- Centro de Onco-Hematologia de Mato Grosso
  • Clinical Research Chile SpA
  • Enroll SpA
  • Clinica Alemana de Osorno
  • Sociedad Medica Del Aparato Locomotor SA
  • Prosalud y cia. Ltda.
  • CINVEC- Estudos Clínicos Quinta Región Limitada
  • First affiliated Hospital of Sun Yat-Sen University
  • First Affiliated Hospital of the Harbin Medical University
  • Wuhan Union Hospital
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Pingxiang People's Hospital
  • China-Japan Union Hospital, CJUH.
  • Zhongshan Hospital, Fudan University
  • Tianjin Medical University General Hospital
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Ningbo First Hospital
  • Peking University First Hospital
  • Beijing Peking Union Medical College Hospital
  • Shanghai Huashan Hospital Affil to Fu Dan University
  • China Medical University (CMU) - First Affiliated Hospital
  • The First Affliated Hospital of Suzhou University
  • The First Affiliated Hospital of Zhengzhou Universtiy
  • HPTU-El Hospital con alma Pablo Tobon Uribe
  • Clinica de la Costa
  • Circaribe SAS
  • Idearg S.A.S.
  • Servimed S.A.S.
  • Centro de Medicina Interna
  • Preventive Care Ltdac
  • Klinicki Bolnicki Centar Rijeka
  • University Hospital Split
  • Revmatologicky ustav
  • Revmatologie.s.r.o.
  • Fakultni nemocnice Olomouc
  • ARTHROHELP s.r.o.
  • VFN a 1 LF University Karlovy
  • CHRU Brest - Hopital Cavale Blanche
  • Centre hospitalier universitaire Pellegrin
  • CHRU Lille - Hopital Claude Huriez
  • Hopital Européen
  • Hôpital de HautePierre
  • Universitätsklinikum Freiburg
  • Universitätsklinikum Tübingen
  • Klinikum der Universität München Großhadern
  • Universitätsklinikum Würzburg A. ö. R.
  • Universitätsmedizin Johannes Gutenberg Universität Mainz
  • Universitätsklinikum Carl Gustav Carus
  • Universitatsklinikum Leipzig
  • Charité Campus Virchow-Klinikum
  • Immanuel Krankenhaus Rheuma Klinik Berlin Buch
  • Schlosspark Klinik
  • Universitaetsklinikum Koeln
  • Gen Hospital of Athens G Gennimatas
  • University General Hospital of Heraklion
  • Regional General University Hospital of Larissa
  • Kianous Stavros
  • Gen. Hosp. of Thessaloniki "Hippokration"
  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
  • Vital Medical Center
  • Budai Irgalmasrendi Korhaz
  • Qualiclinic
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
  • Debreceni Egyetem Klinikai Kozpont
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
  • Vita Verum Egeszsegugyi Szolgaltato Bt
  • Panchshil hospital
  • CIMS Hospital Private Limited
  • Shree Giriraj Hospital
  • Nirmal Hospital Private Limited
  • Sterling Hospital
  • ChanRe Rheumatology And Immunology Center And Research
  • St. John Medical College & Hospital
  • Sushruta Multispecialty Hospital & Research Center Pvt Ltd
  • Kasturba Medical College Hospital, Mangalore
  • Jasleen Hospital
  • Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
  • Fortis Escorts Hospital
  • Krishna Institute of Medical Science
  • Meir Medical Center
  • Sheba Medical Center
  • Carmel Hospital
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Universitaria Pisana
  • Azienda Policlinico Umberto I
  • Azienda Ospedaliera Santa Maria Della Misericordia
  • University of Occupational and Enviromental Health
  • National Hospital Organization Asahikawa Medical Center
  • Hokkaido University Hospital
  • Jp Red Cross Society Himeji Hp
  • Kobe University Hospital
  • Kagawa University Hospital
  • Tohoku University Hospital
  • Tomishiro Central Hospital
  • Seirei Hamamatsu General Hospital
  • Juntendo University Hospital
  • Nippon Medical School Hospital
  • Showa University Hospital
  • National Hospital Organization Kyushu Medical Center
  • Hamanomachi Hospital
  • Hiroshima University Hospital
  • St. Luke's International Hospital
  • Keio university hospital
  • Seoul National University Bundang Hospital
  • Kyung Pook National University Hospital
  • Chungnam National University Hospital
  • Gachon University Gil Hospital
  • Hanyang University Medical Center
  • Asan Medical Center
  • Seoul St. Mary's Hospital
  • Dr. Alberto Esteban Bazzoni Ruiz
  • Clinica para el Diagnostico y Tratamiento de la Enfermedades
  • Morales Vargas Centro de Investigacion, S.C.
  • Centro Integral en Reumatologia SA de CV
  • Clinica de Investigacion en Reumatologia y Obesidad S. C.
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
  • Centro de Alta Especialidad Reumatologia Inv del Potosi SC
  • Consultorio Jose Luis Garcia Figueroa
  • Köhler & Milstein Research
  • Centro Peninsular de Investigacion S.C.P
  • Cemdeicy S.C.P.
  • Centro de Investigación y Tratamiento Reumatológico S.C
  • Clinosar Mexico S.A. de C.V
  • Consultorio de Reumatologia
  • Oaxaca Site Management Organization
  • Medische Centrum Leeuwarden
  • Vrije Universiteit Medisch Centrum Amsterdam
  • Mary Mediatrix Medical Center
  • Cebu Doctors Hospital
  • Chong Hua Hospital
  • Southern Philippines Medical Center
  • Makati Medical Center
  • St. Luke's Medical Center
  • Angeles University Foundation and Medical Center
  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej
  • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Medycyna Kliniczna
  • Reumatika - Centrum Reumatologii
  • Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
  • Zespol Poradni Specjalistycznych REUMED
  • Ambulatorium Barbara Bazela
  • Centrum Medyczne Pratia Katowice
  • MCM Krakow - PRATIA - PPDS
  • Centrum Medyczne Plejady
  • NZOZ Lecznica MAK-MED s.c.
  • Klinika Reumatologii i Rehabilitacji
  • Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM
  • Centrum Medyczne AMED
  • C.M.D.T.A. Neomed
  • Spitalul Euroclinic
  • Napoca Emergency Clinical County Hospital
  • Craiova Emergency Clinical County Hospital
  • SANA Medical Center
  • Spitalul Clinic Sf Maria Bucuresti
  • Spitalul Clinic "Dr. Ioan Cantacuzino"
  • Moscow City Clinical Hospital Number 52
  • LLC MK Med
  • Chelyabinsk Regional Clinical Hospital
  • City Hospital # 7
  • V.A. Nasonova Research Institute of Rheumatology
  • Russian National Research Medical University n.a. N.I.Pirogov
  • City Clinical Hospital 1 named after N.I. Pirogov
  • Research Institute of Clinical Immunology
  • Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
  • Regional Hospital - Omsk
  • Orenburg State Medical Academy of Roszdrav
  • Kursk Regional Clinical Hospital
  • Ryazan State Medical University
  • Russian Medical Military Academy n.a. S.M. Kirov
  • Departmental Hospital at Smolensk Station "rzhd" JSC
  • Kuvatov Republican Clinical Hospital
  • LLC Medical Center Zdorovaya Semiya
  • Institute of Rheumatology
  • Military Medical Academy
  • University Clinical Center of Serbia
  • Institute for Treatment and Rehabilitation Niska Banja
  • Clinical Center of Vojvodina
  • Suite 509 Umhlanga Netcare Medical Centre
  • WITS Clinical Research
  • Jakaranda Hospital
  • Vincent Pallotti Hospital
  • Panorama Medical Centre
  • Winelands Medical Research Centre
  • University Of Pretoria
  • Hospital Marina Baixa
  • Hospital Universitari Vall d'Hebron
  • Corporacion Sanitaria Parc Tauli
  • Hospital De Fuenlabrada
  • Hospital do Meixoeiro
  • Corporació Sanitària Clínic
  • Hospital Quiron Infanta Luisa
  • Cantonal Hospital St.Gallen
  • Hualien Tzu-Chi Hospital
  • Kaohsiung Veterans General Hospital
  • Chang Gung Memorial Hospital - Kaohsiung Branch
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Chi-Mei Medical Center
  • National Taiwan University Hospital
  • Taipei Medical University Hospital
  • Chang Gung Memorial Hospital - Linkou
  • Maidstone Hospital
  • Whipps Cross University Hospital
  • St George's Hospital
  • Guys/St. Thomas Hospital
  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • Leeds Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

2 mg Baricitinib

4 mg Baricitinib

Placebo to 2 mg Baricitinib

Placebo to 4 mg Baricitinib

Arm Description

Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).

Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.

Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies.
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Percentage of Participants With Temporary Investigational Product Interruptions
Percentage of participants with temporary investigational product interruptions.
Percentage of Participants With Permanent Investigational Product Discontinuations
Percentage of participants with permanent investigational product discontinuations.

Secondary Outcome Measures

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
SRI-4 response defined as 1)greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Percentage of participants achieving a LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.
Change From Baseline in Prednisone Dose
Change from baseline in prednisone dose.
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25.
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score
The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Change From Baseline in Tender Joint Count
The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Change From Baseline in Swollen Joint Count
The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score
The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0 indicates no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Change from baseline in Worst Pain NRS. It is assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". Overall severity of a patient's pain is indicated by selecting the number that best describes the worst level of pain during the past 7 days.

Full Information

First Posted
February 14, 2019
Last Updated
May 12, 2023
Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03843125
Brief Title
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
Acronym
SLE-BRAVE-X
Official Title
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation

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 reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
Arm Title
4 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
Arm Title
Placebo to 2 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
Arm Title
Placebo to 4 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Week 134
Title
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Description
Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies.
Time Frame
Week 134
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Description
Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame
Week 134
Title
Percentage of Participants With Temporary Investigational Product Interruptions
Description
Percentage of participants with temporary investigational product interruptions.
Time Frame
Week 134
Title
Percentage of Participants With Permanent Investigational Product Discontinuations
Description
Percentage of participants with permanent investigational product discontinuations.
Time Frame
Week 134
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
Description
SRI-4 response defined as 1)greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
Time Frame
Week 134
Title
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Description
Percentage of participants achieving a LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.
Time Frame
Week 48
Title
Change From Baseline in Prednisone Dose
Description
Change from baseline in prednisone dose.
Time Frame
Baseline through Week 48
Title
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
Description
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25.
Time Frame
Baseline through Week 48
Title
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score
Description
The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Time Frame
Week 48
Title
Change From Baseline in Tender Joint Count
Description
The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Time Frame
Baseline through Week 48
Title
Change From Baseline in Swollen Joint Count
Description
The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Time Frame
Baseline trough Week 48
Title
Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score
Description
The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0 indicates no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.
Time Frame
Baseline through Week 48
Title
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Description
Change from baseline in Worst Pain NRS. It is assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". Overall severity of a patient's pain is indicated by selecting the number that best describes the worst level of pain during the past 7 days.
Time Frame
Baseline through Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
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
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P. C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Wallace Rheumatic Studies Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Medvin Clinical Research - Weidmann
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
MD Medical Corporation
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
ACRC Studies
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Inland Rheumatology & Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Medvin Clinical Research - Weidmann
City
Whittier
State/Province
California
ZIP/Postal Code
90602
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
Arthritis and Rheumatic Disease
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Clinical Research of West Florida, Inc. (Clearwater)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Lakes Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
IRIS Research and Development, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
North Georgia Rheumatology, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Arthritis Center of Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Johns Hopkins Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Advanced Rheumatology, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Glacir View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Allied Clinical Research
City
Reno
State/Province
Nevada
ZIP/Postal Code
89519
Country
United States
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
St. Lawrence Health System
City
Canton
State/Province
New York
ZIP/Postal Code
13617
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Joint and Muscle Medical Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Box Arthritis & Rheumatology of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Medication Management
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5046
Country
United States
Facility Name
East Penn Rheumatology Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
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
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Eagle Medical
City
Crossville
State/Province
Tennessee
ZIP/Postal Code
38555
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Accurate Clinical Management
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Dr. Dhiman Basu Private Practice
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Rheumatology Center Of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Southwest Rheumatology, P.A.
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Rheumatology of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
Arthritis Clinic of Northern VA, P.C.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Spectrum Medical Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Aprillus Asistencia e Investigacion de Arcis Salud SRL
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1046
Country
Argentina
Facility Name
DOM Centro de Reumatologia
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1111AAH
Country
Argentina
Facility Name
Framingham Centro Medico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
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
Clinica Adventista Belgrano
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Sanatorio Británico
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
IR Medical Center S.A. Instituto de Reumatologia
City
Mendoza
ZIP/Postal Code
M5500CPH
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman
City
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Optimus Clinical Research
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
The Rheumatology Research Unit Sunshine Coast
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. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
A O Krankenhaus der Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Centro de Estudos em Terapias Inovadoras-CETI
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
EDUMED - Educação em Saúde Ltda.
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
LMK Serviços Médicos S/S
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90540-000
Country
Brazil
Facility Name
Hospital de Clinicas UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Oncovida- Centro de Onco-Hematologia de Mato Grosso
City
Cuiaba
ZIP/Postal Code
78043-142
Country
Brazil
Facility Name
Clinical Research Chile SpA
City
Valdivia
State/Province
Los Ríos
ZIP/Postal Code
5110683
Country
Chile
Facility Name
Enroll SpA
City
Providencia
State/Province
Región Metropolitana De Santia
ZIP/Postal Code
7500587
Country
Chile
Facility Name
Clinica Alemana de Osorno
City
Osorno
ZIP/Postal Code
5290000
Country
Chile
Facility Name
Sociedad Medica Del Aparato Locomotor SA
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Prosalud y cia. Ltda.
City
Santiago
Country
Chile
Facility Name
CINVEC- Estudos Clínicos Quinta Región Limitada
City
Vina del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
First affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
First Affiliated Hospital of the Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337000
Country
China
Facility Name
China-Japan Union Hospital, CJUH.
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Shanghai Huashan Hospital Affil to Fu Dan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
China Medical University (CMU) - First Affiliated Hospital
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
The First Affliated Hospital of Suzhou University
City
Suzhou Shi
ZIP/Postal Code
215000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou Universtiy
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Facility Name
HPTU-El Hospital con alma Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Clinica de la Costa
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Circaribe SAS
City
Barranquilla
State/Province
Atlántico
Country
Colombia
Facility Name
Idearg S.A.S.
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Servimed S.A.S.
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
12345
Country
Colombia
Facility Name
Centro de Medicina Interna
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Facility Name
Preventive Care Ltdac
City
Chia
Country
Colombia
Facility Name
Klinicki Bolnicki Centar Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
University Hospital Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Revmatologicky ustav
City
Praha 2
State/Province
Praha, Hlavní Mešto
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Revmatologie.s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
ARTHROHELP s.r.o.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
VFN a 1 LF University Karlovy
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHRU Brest - Hopital Cavale Blanche
City
Brest Cedex
State/Province
Finistère
ZIP/Postal Code
29609
Country
France
Facility Name
Centre hospitalier universitaire Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Hôpital de HautePierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum der Universität München Großhadern
City
München
State/Province
Bayern
ZIP/Postal Code
81337
Country
Germany
Facility Name
Universitätsklinikum Würzburg A. ö. R.
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Universitätsmedizin Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
4103
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Immanuel Krankenhaus Rheuma Klinik Berlin Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Schlosspark Klinik
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Gen Hospital of Athens G Gennimatas
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Irakleío
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Regional General University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41 221
Country
Greece
Facility Name
Kianous Stavros
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Gen. Hosp. of Thessaloniki "Hippokration"
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
City
Gyula
State/Province
Békés
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprem
State/Province
Veszprém City
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Qualiclinic
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Vita Verum Egeszsegugyi Szolgaltato Bt
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Panchshil hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380005
Country
India
Facility Name
CIMS Hospital Private Limited
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
Shree Giriraj Hospital
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360004
Country
India
Facility Name
Nirmal Hospital Private Limited
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Sterling Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390007
Country
India
Facility Name
ChanRe Rheumatology And Immunology Center And Research
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
St. John Medical College & Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Sushruta Multispecialty Hospital & Research Center Pvt Ltd
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580021
Country
India
Facility Name
Kasturba Medical College Hospital, Mangalore
City
Madhav Nagar, Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
Jasleen Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Facility Name
Fortis Escorts Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Krishna Institute of Medical Science
City
Secunderabad
State/Province
Telengana
ZIP/Postal Code
500003
Country
India
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Carmel Hospital
City
Haifa
State/Province
Ḥeifā
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
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
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Jp Red Cross Society Himeji Hp
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tomishiro Central Hospital
City
Tomigusuku
State/Province
Okinawa
ZIP/Postal Code
901-0243
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8555
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810 8563
Country
Japan
Facility Name
Hamanomachi Hospital
City
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Keio university hospital
City
Tokyo
ZIP/Postal Code
1600035
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
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
Chungnam National University Hospital
City
Daejeon
State/Province
Korea
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
State/Province
Korea
ZIP/Postal Code
21565
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
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
Dr. Alberto Esteban Bazzoni Ruiz
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Clinica para el Diagnostico y Tratamiento de la Enfermedades
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion, S.C.
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro Integral en Reumatologia SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
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
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
City
San Luis Potosi
State/Province
SLP
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Consultorio Jose Luis Garcia Figueroa
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
89190
Country
Mexico
Facility Name
Köhler & Milstein Research
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro Peninsular de Investigacion S.C.P
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Cemdeicy S.C.P.
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Centro de Investigación y Tratamiento Reumatológico S.C
City
Ciudad De México
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Clinosar Mexico S.A. de C.V
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Consultorio de Reumatologia
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Medische Centrum Leeuwarden
City
Leeuwarden
State/Province
Fryslân
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Mary Mediatrix Medical Center
City
Lipa
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Cebu Doctors Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Chong Hua Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Southern Philippines Medical Center
City
Davao
State/Province
Davao Del Norte
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati
State/Province
Luzon
ZIP/Postal Code
1229
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
State/Province
Luzon
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Angeles University Foundation and Medical Center
City
Angeles City
State/Province
Pampanga
ZIP/Postal Code
2009
Country
Philippines
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53224
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Twoja Przychodnia Centrum Medyczne Nowa Sol
City
Nowa Sol
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Medycyna Kliniczna
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00874
Country
Poland
Facility Name
Reumatika - Centrum Reumatologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-077
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych REUMED
City
Lublin
State/Province
Polska
ZIP/Postal Code
20582
Country
Poland
Facility Name
Ambulatorium Barbara Bazela
City
Elblag
State/Province
Warminsko-Mazurki
ZIP/Postal Code
82300
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
MCM Krakow - PRATIA - PPDS
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30363
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED s.c.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Klinika Reumatologii i Rehabilitacji
City
Poznan
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
C.M.D.T.A. Neomed
City
Brasov
State/Province
Brașov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Spitalul Euroclinic
City
Bucureti
State/Province
București
ZIP/Postal Code
14461
Country
Romania
Facility Name
Napoca Emergency Clinical County Hospital
City
Napoca
State/Province
Cluj
ZIP/Postal Code
40006
Country
Romania
Facility Name
Craiova Emergency Clinical County Hospital
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200642
Country
Romania
Facility Name
SANA Medical Center
City
Bucharest
ZIP/Postal Code
11025
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
Moscow City Clinical Hospital Number 52
City
Moscow
State/Province
Moskva
Country
Russian Federation
Facility Name
LLC MK Med
City
St. Petersburg
State/Province
Saint Petersburg
ZIP/Postal Code
197372
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
City Hospital # 7
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
V.A. Nasonova Research Institute of Rheumatology
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Russian National Research Medical University n.a. N.I.Pirogov
City
Moscow
ZIP/Postal Code
117997
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
Research Institute of Clinical Immunology
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Regional Hospital - Omsk
City
Omsk
ZIP/Postal Code
644111
Country
Russian Federation
Facility Name
Orenburg State Medical Academy of Roszdrav
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Kursk Regional Clinical Hospital
City
Rursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Ryazan State Medical University
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Russian Medical Military Academy n.a. S.M. Kirov
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Departmental Hospital at Smolensk Station "rzhd" JSC
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Kuvatov Republican Clinical Hospital
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
LLC Medical Center Zdorovaya Semiya
City
Zonova
ZIP/Postal Code
630061
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Treatment and Rehabilitation Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Clinical Center of Vojvodina
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Suite 509 Umhlanga Netcare Medical Centre
City
Umhlanga
State/Province
Durban
ZIP/Postal Code
4319
Country
South Africa
Facility Name
WITS Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Jakaranda Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Vincent Pallotti Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Panorama Medical Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
University Of Pretoria
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital Marina Baixa
City
La Vila Joiosa
State/Province
Alicante
ZIP/Postal Code
03570
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
8035
Country
Spain
Facility Name
Corporacion Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital De Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28944
Country
Spain
Facility Name
Hospital do Meixoeiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Corporació Sanitària Clínic
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Cantonal Hospital St.Gallen
City
st.Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Hualien Tzu-Chi Hospital
City
Dalin Township
ZIP/Postal Code
622
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Chi-Mei Medical Center
City
Tainan City
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
St George's Hospital
City
Tooting
State/Province
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Guys/St. Thomas Hospital
City
London
State/Province
Surrey
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Leeds Teaching Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
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/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/522BW42nIOGg3wGqAYUcrw
Description
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

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A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

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