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Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
tofacitinib
tofacitinib
adalimumab
etanercept
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Post-marketing, Phase 4, Open-label, Safety Surveillance, CP690550, Xeljanz, oral treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Moderate to severe rheumatoid arthritis
  • Taking methotrexate without adequate control of symptoms
  • Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

Exclusion Criteria:

  • Current or recent infection
  • Clinically significant laboratory abnormalities
  • Pregnancy

Sites / Locations

  • University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program
  • Rheumatology Associates of North Alabama, PC
  • Clinical and Translational Research Center of Alabama, PC
  • Southern Arizona VA Health Care System (SAVAHCS)
  • University of Arizona Clinical and Translational Science Research Center
  • CHI St. Vincent Medical Group Hot Springs
  • Arthritis And Rheumatism Associates LLC
  • Medvin Clinical Research
  • Med Investigations, Inc.
  • Talbert Medical Group
  • University of California, San Diego (UCSD)- Perlman Ambulatory Clinic
  • Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
  • ProHealth Partners
  • Keck Medicine of USC
  • California Medical Research Associates Inc
  • Desert Medical Advances
  • Medvin Clinical Research
  • Sierra Rheumatology, Inc.
  • San Diego Arthritis Medical Clinic
  • Dr. Orrin M. Troum, Md And Medical Associates
  • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
  • Harbor UCLA Medical Center
  • Robin K. Dore M.D., Inc.
  • Medvin Clinical Research
  • Ventura Clinical Trials
  • Desert Valley Medical Group
  • Medvin Clinical Research
  • Arthritis Associates and Osteoporosis Center of Colorado Springs
  • Howard University Hospital
  • RASF-Clinical Research Center, Inc
  • Bay Area Arthritis and Osteoporosis
  • Arthritis & Rheumatism Associates (Private Practice)
  • Florida Clinical Research Group (Administrative Office)
  • Dr.Robert W. Levin MDOffice of
  • International Medical Research
  • Centre for Rheumatology, Immunology and Arthritis
  • University of Florida - Rheumatology at ACC
  • University of Florida College of Medicine, Jacksonville - Rheumatology Research
  • San Marcus Research Clinic
  • Doctors Research Institute
  • Center for Arthritis and Rheumatic Diseases
  • Ocala Rheumatology Research Center
  • Advanced Clinical Research of Orlando
  • Arthritis & osteoporosis treatment center,PA
  • Rheumatology Associates of Central Florida, PA
  • Omega Research Consultants, LLC
  • Millennium Research
  • Arthritis Center, Inc.
  • Arthritis Research of Florida, Inc.
  • Advanced Medical Research Center
  • Advanced Urgent Care
  • USF Health Morsani Center for Advanced Healthcare
  • Florida Medical Clinic, P.A.
  • Arthritis and Rheumatology of GA, P.C.
  • Medical Associates of North Georgia - Rheumatology
  • Office of Jefrey D. Lieberman, MD, PC
  • Coeur D'Alene Arthritis Clinic
  • Quincy Medical Group
  • Springfield Clinic
  • Diagnostic Rheumatology and Research PC
  • MidWest Clinical Research, LLC
  • Professional Research Network of Kansas, LLC
  • Arthritis and Diabetes Clinic, Inc.
  • Klein & Associates, M.D.,P.A.
  • Arthritis Treatment Center
  • Klein & Associates, MD, PA
  • The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC
  • Phase III Clinical Research
  • UMass Memorial Medical Center, Memorial Campus
  • Bronson Healthcare Group
  • Bronson Rheumatology Specialists
  • Jasper Clinic, Inc.
  • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
  • Borgess Medical Center
  • Borgess Research Institute
  • June DO,PC
  • Shores Rheumatology P.C.
  • St. Paul Rheumatology, PA
  • Center for Diagnostic Imaging
  • Mayo Clinic
  • Kansas City Internal Medicine
  • Clinvest Research, LLC
  • Glacier View Research Institute
  • Physician Research Collaboration, LLC
  • Westroads Clinical Research, Inc.
  • University of Nevada School of Medicine
  • Steinberg Diagnostics
  • EKSAKTI, LLC (dba: Eksakti Clinical Research)
  • Arthritis Center Of Reno
  • Nashua Rheumatology
  • Summit Medical Group
  • Weill Cornell Physicians at Brooklyn Heights
  • Northwell Health Division of Rheumatology
  • NYU Langone Rheumatology Associates Long Island.
  • EmergeOrtho,P.A.
  • Physicians East, PA
  • PMG Research of Hickory LLC
  • Frycare outpatient imaging Center
  • PMG Research of Hickory, LLC
  • PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
  • Carolina Arthritis Associates
  • St. Alexius Medical Center
  • Trinity Health Center - Medical Arts
  • Cincinnati Rheumatic Disease Study Group, Inc.
  • STAT Research, Inc.
  • Health Research of Oklahoma
  • Oklahoma Medical Research Foundation (OMRF)
  • Lynn Health Science Institute
  • Altoona Center for Clinical Research
  • The Arthritis Group
  • UPMC Arthritis and Autoimmunity Clinic
  • UPMC Lupus Center of Excellence
  • Clinical Research Center of Reading, LLC
  • Rheumatology Associates, P.A.
  • Innovative Clinical Research, LLC
  • Piedmont Arthritis Clinic, PA
  • Articluaris Healthcare Group d/b/a ACME Research
  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
  • West Tennessee Research Institute
  • Rheumatology Consultants, PLLC
  • Dr. Ramesh C. Gupta MD, Office of
  • Center For Inflammatory Disease
  • Amarillo Center for Clinical Research, Ltd.
  • Austin Regional Clinic
  • Trinity Universal Research Associates, Inc
  • Pioneer Research Solutions, Inc.
  • Baylor Scott and White Research Institute / Arthritis Care and Research Center
  • Arthritis Centers of Texas
  • UT Southwestern Medical Center
  • Accurate Clinical Management, LLC
  • Rheumatic Disease Clinical Research Center
  • Accurate Clinical Research, Inc.
  • Houston Institute for Clinical Research
  • Accurate Clinical Management, LLC
  • Medical Center Research, LLC
  • Accurate Clinical Research, Inc.
  • Arthritis and Osteoporosis Associates, LLP
  • Southwest Rheumatology Research, LLC
  • Trinity Universal Research Associates, Inc.
  • Center for Arthritis and Rheumatic Diseases, PC
  • Center for Arthritis and Rheumatic Diseases, P.C.
  • Rheumatic Disease Center
  • OMI- Organizacion Medica de Investigacion
  • Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
  • Sanatorio Parque S.A y Consultorios Externos Asociados
  • Centro Medico Privado de Reumatologia
  • Consultorios Reumatologicos Pampa.
  • CIER - Centro de Investigaciones en Enfermedades Reumaticas
  • Centro Privado de Medicina Familiar - Mindout Research S.R.L.
  • Hospital Privado Centro Medico de Cordoba S.A.
  • Sanatorio Parque S.A y Consultorios Externos Asociados
  • I.A.R.I. Instituto de Asistencia Reumatologica Integral - Sede IMAC
  • CER San Juan
  • The Queen Elizabeth Hospital
  • St. Vincent's Hospital (Melbourne)
  • Austin Health - Repatriation Hospital
  • Austin Repatriation Hospital
  • RK Will Pty Ltd
  • SER - Servicos Especializados em Reumatologia da Bahia
  • CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo
  • CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
  • Hospital das Clinicas Universidade Federal de Minas Gerais
  • EDUMED - Educacao em Saude SS Ltda
  • CCBR Brasil - Centro de Pesquisas e Analises Clinicas LTDA
  • Hospital de Clinicas de Porto Alegre - UFRGS
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • Clinica Medica Bonfliglioli Ltda.
  • CPCLin - Centro de Pesquisas Clinicas Ltda. / Clinica Dr. Freddy Goldberg Eliaschewitz LTDA EPP
  • AACD- Lar Escola\ Associacao de Assistencia a Crianca Deficiente
  • Instituto de Assistencia Medica do Hospital do Servidor Publico Estadual
  • Fundacao Faculdade de Medicina MECMPAS - Hospital das Clinicas da FMUSP
  • Hospital Israelita Albert Einstein
  • Hospital Moinhos de Vento
  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
  • UMBAL "Dr Georgi Stranski" EAD
  • MBAL Eurohospital Plovdiv OOD
  • MBAL RUSe AD,
  • UMBAL Sveti Ivan Rilski" EAD
  • MBAL Sveta Marina EAD
  • Rheumatology Research Associates
  • PerCuro Clinical Research Limited
  • Medicine Professional Corporation
  • Clinical Research and Arthritis Centre
  • Centre de Rhumatologie de l'Est du Quebec
  • Centre de Recherche Musculo-Squelettique
  • Prosalud
  • Centro Medico de Reumatologia Ltda.
  • Centro de Investigacion Clinica Universidad Catolica (CICUC)
  • Guangdong General Hospital
  • Centro Integral de Reumatologia REUMALAB S.A.S.
  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
  • Centro de Investigaciones Clinica del Country
  • Preventive Care S.A.S.
  • Servimed S.A.S
  • Vesalion, s.r.o.
  • Mediscan Group, s.r.o.
  • Revmacentrum MUDr. Mostera, s.r.o.
  • REVMACLINIC s.r.o.
  • Revmatologie, s.r.o.
  • Artroscan, s.r.o.
  • Revmatologicky ustav.
  • Revmatologicka Ambulance
  • PV - MEDICAL s.r.o.
  • Helsingin yliopistollinen keskussairaala
  • Kiljavan Laaketutkimus Oy
  • Laakarikeskus Aava Hyvinkaan Pipetti
  • Pamela Youde Nethersole Eastern Hospital
  • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
  • Tuen Mun Hospital
  • Prince of Wales Hospital
  • Barzilai Medical Center - Rheumatology Outpatient Clinic
  • Assaf Harofeh Medical Center
  • Bnai Zion Medical Center Rheumatology Unit
  • Rambam Health Care Campus
  • Carmel Medical Center
  • Hadassah Medical Center - Hebrew University Hospital
  • Meir Medical Center
  • Rabin Medical Center
  • Tel Aviv Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • Istishari Hospital
  • King Abdullah University Hospital
  • Hotel Dieu de France Hospital
  • Ain Wazein Hospital
  • Hospital Raja Permaisuri Bainun
  • Sarawak General Hospital
  • Hospital Selayang, Department of Medicine
  • Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
  • Consultorio de Reumatologia
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Centro Integral en Reumatologia SA de CV
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Centro de Investigacion Clinica de Morelia. S.C
  • Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
  • Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
  • Unidad Reumatologica Las Americas S.C.P.
  • Investigacion y Biomedicina de Chihuahua SC
  • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
  • Unidad de Investigaciones Reumatologicas
  • Medical Center Leeuwarden
  • Universitair Medisch Centrum (UMC) Utrecht
  • Middlemore Hospital Middlemore Clinical Trials Trust
  • Rheumatology Clinic, Waikato Hospital
  • Timaru Hospital
  • Wellington Hospital
  • Centro de Investigacion Clinica Trujillo E.I.R.L. Clinica Peruana Americana
  • Centro de lnvestigacion de la Red Asistencial del Hospital Nacional ESSALUD Carlos Alberto Seguin E.
  • ACQ MEDIC S.A.C. - Centro de Investigacion Clinica Inmunoreumatologia
  • Unidad de Investigacion de la Clinica Internacional - Clinica Internacional
  • ABK REUMA S.R.L. de Medicentro Biociencias- BIO CIENCIAS PERU S.R.L.
  • Instituto Peruano del Hueso y la Articulacion - Instituto Peruano del Hueso y la Articulacion S.A.C.
  • Investigaciones en Reumatologia - Centro Medico Corpac
  • Investigaciones Clinicas S.A.C.
  • Centro de Investigacion de Reumatologia - Clinica San Borja
  • Centro de Investigacion en Salud - Centro de Excelencia en Reumatologia
  • NZOZ Lecznica MAK-MED
  • Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
  • Centrum Medyczne Pratia Gdynia
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Centrum Medyczne Pratia Katowice
  • Indywidualna Praktyka lekarska Dr hab. med. Anna Szczepańska - Szerej
  • Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
  • PROFMEDICUS Sp. z o.o., Osrodek Badan Klinicznych
  • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
  • Pomorskie Centrum Reumatologiczne im. Dr Jadwigi Titz-Kosko w Sopocie, Spolka. z o.o.
  • KO-MED Centra Kliniczne Sp. zo.o.
  • NASZ LEKARZ Przychodnie Medyczne
  • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Centrum Medyczne Pratia Warszawa
  • Synexus Polska Sp. z o.o.
  • NZOZ Biogenes Sp. z o.o.
  • Ponce Medical School Foundation, Inc.
  • Fundacion de Investigaction de Diego
  • Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the
  • SBHI City Clinical Hospital #4 of HD of Moscow
  • SBHI of Moscow City Clinical Hospital 1 n. a. N.I. Pirogov of the Healthcare Department of Moscow
  • SBIH of Nizhniy Novgorod region City Clinical Hospital #5 of Nizhniy Novgorod district
  • Federal State Budgetary Scientific Institution "Research Institute of Fundamental and
  • Consulting and Diagnostic Rheumatological Center Healthy Joints LLC
  • GBUZ RK Republic Hospital n. a. V.A. Baranov of the MoH & social development Of The Karelia Republic
  • Federal State Budgetary Educational Institution of Higher Education
  • Saint-Petersburg State Budget Healthcare Institution Consultative-diagnostic Center #85
  • SBEI of HPE Ural State Medical University of the MoH of the RF
  • Municipal Budgetary Institution "Central City Clinical Hospital #6"
  • ROMJAN s.r. o. , Specializovana Reumatologicka ambulancia
  • Nestatna reumatologicka ambulancia
  • AAGS, s.r.o., Reumatologicka ambulancia
  • ECCLESIA s.r.o, Reumatologicka ambulancia
  • REUMACENTRUM s.r.o., Reumatologicka ambulancia
  • Reumex s.r.o
  • Reuma-Global s.r.o., Reumatologicka ambulancia
  • Greenacres Hospital
  • Wits Clinical Research Site
  • Clinresco Centres ( Pty ) Ltd
  • Jakaranda Hospital
  • Emmed Research
  • St. Augustine's Hospital - Chelmsford Medical Centre 2
  • Tiervlei Trial Centre, Karl Bremer Hospital
  • Arthritis Clinical Research Trials cc
  • Panorama Medical Centre
  • University of Cape Town
  • Winelands Medical Research Centre-
  • Hospital de Merida
  • Hospital Universitario Marques de Valdecilla
  • Hospital Nuestra Senora de la Esperanza
  • Hospital Universitario de Cruces
  • Hospital Universitario de Basurto
  • Hospital Plato
  • Hospital De La Santa Creu I Sant Pau
  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario de Malaga
  • Hospital Universitario Virgen de la Macarena
  • China Medical University Hospital
  • Changhua Christian Hospital
  • Buddhist Dalin Tzu Chi General Hospital
  • Chung Shan Medical University Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation - Linkou Branch
  • Phramongkutklao Hospital
  • Ramathibodi Hospital, Mahidol University
  • Faculty of Medicine , Siriraj Hospital , Mahidol University
  • Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,Chiang Mai University
  • Prince of Songkla University
  • Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
  • Hacettepe Universitesi Tip Fakultesi
  • Adnan Menderes Universitesi Tip Fakultesi Hastanesi
  • Gaziantep Universitesi Tip Fakultesi
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Izmir Tepecik Egitim ve Arastirma Hastanesi
  • Kocaeli Universitesi Tip Fakultesi Hastanesi
  • Ondokuz Mayis Universitesi Tip Fakultesi Fiziksel Tip ve
  • Cumhuriyet Universitesi Tip Fakultesi Hastanesi
  • Poole Hospital, University Hospitals Dorset NHS Foundation Trust
  • Barking, Havering and Redbridge University Hospitals NHS Trust
  • The Royal Wolverhampton NHS Trust-Cannock Chase Hospital
  • Aintree University Hospital, Liverpool University Hospitals
  • Clinical trials, Pharmacy Department, Aintree University Hospitals
  • University of Liverpool Academic Rheumatology Unit. Aintree University Hospital. Liverpool Universit
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Clinical Research Facility
  • Northumbria Healthcare NHS Foundation Trust
  • Pharmacy Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment Arm 1

Treatment Arm 2

Treatment Arm 3

Arm Description

TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.

Outcomes

Primary Outcome Measures

Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
Incidence rate (number of participants with event per 100 participant year [PY]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
MACE included the cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke of any classification, including reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.

Secondary Outcome Measures

Incidence Rate of Non-fatal Stroke
Non-fatal stroke included reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Incidence Rate of Non-fatal Myocardial Infarction
Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
Opportunistic infections (OI) were reviewed and adjudicated by the opportunistic infection review committee (OIRC). Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Incidence Rate of Adjudicated Hepatic Events
Hepatic events (adjudicated) included drug-induced liver injury (DILI) - probable, highly likely and definite, DILI - listed separately, DILI - cases meeting classification and severity, participants with elevations of transaminase levels greater than (>) 1* upper limit of normal (ULN), greater than or equal to (>=) 3*ULN, >=5*ULN (based on laboratory values). Incidence rate was the total number of participants with admissible events divided by total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was minimum of The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.
Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
Cardiovascular events (adjudicated) were death (coronary and non-coronary), MI, all coronary revascularization, unstable angina, new ischemic heart disease, stroke (fatal and non-fatal), transient ischemic attack (TIA), congestive heart failure (CHF), peripheral arterial vascular disease (PAVD), deep vein thrombosis, pulmonary embolism, arterial embolism, arterial thrombosis. Incidence rate was total number of participants with admissible events divided by total (for all qualifying participants) time at risk for cohort/treatment group of interest. Risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE was any untoward medical occurrence post treatment; event need not necessarily had causal relationship with treatment or usage. SAE: any untoward medical occurrence at any dose: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly. TEAE: event that occurred for first time during effective duration of treatment and not seen prior to start of treatment or event seen prior to start of treatment but increase in severity during treatment. Risk period (RP) for AE: minimum of last contact date or last study treatment dose date+28 days. RP for SAEs: last contact date. Last contact date was maximum: AE start, AE stop, last study visit, withdrawal and telephone contact. In case of death, last contact was death date. First events counted within RP. Participant did not have event or had event outside risk period were censored at end of RP.
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Clinically significant laboratory abnormalities: Hematology: hemoglobin, hematocrit, erythrocytes with primary criteria as less than [<] 0.8* lower limit of normal [LLN]), platelets (<0.5* LLN; >1.75* ULN), leukocytes (<0.6*LLN; >1.5*ULN), lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes (<0.8*LLN; >1.2*ULN), eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes (>1.2*ULN); urinalysis: urine glucose, urine protein, urine hemoglobin, and leukocyte esterase (>=1); chemistry: bilirubin, indirect bilirubin (>1.5*ULN) aspartate aminotransferase, alanine aminotransferase (>3.0*ULN), creatinine, triglycerides, cholesterol (>1.3*ULN) and HDL cholesterol (<0.8*LLN). Risk period (RP) was minimum of last contact date or last study treatment dose date+28 days. Last contact date was (date of death or maximum of dates: AE start, AE stop, last study visit, withdrawal, telephone contact). Participants without event or event outside RP were censored at end of RP.
Incidence Rate of Adjudicated All-Cause Deaths
All-cause death was defined as the death due to any cause during the course of study. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Incidence rate of all-cause deaths (adjudicated by Adjudication Committee) was reported in this outcome measure. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication
Number of participants who permanent or temporary discontinued study medication due to any AE, treatment related AEs, Coronavirus disease 2019 (COVID 19) related AEs, and herpes zoster were reported. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (milligrams per liter [mg/L]) and patient's global assessment of disease activity (PtGA) on a 100 mm Visual Analog Scale (VAS) (scores ranging from 0 millimeter [mm] [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and physician's global assessment of health (PhyGA) both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria
ACR-EULAR Boolean-based definition of remission participant must satisfy all of the following: TJC28 <=1, SJC28 <=1, CRP <=10 mg/L, PtGA on a 0-100 mm scale, higher scores indicate greater affection due to disease activity.
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2
DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
ACR20 response is a >= 20% improvement in TJC (28) and SJC (28) and >=20% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
Number of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response is a >= 50% improvement in TJC (28) and SJC (28) and >=50% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
Number of Participants With an American College of Rheumatology 70% (ACR70) Response
ACR70 response is a >= 70% improvement in TJC (28) and SJC (28) and >=70% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Full Information

First Posted
March 3, 2014
Last Updated
July 21, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02092467
Brief Title
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Official Title
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 14, 2014 (Actual)
Primary Completion Date
July 22, 2020 (Actual)
Study Completion Date
July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Post-marketing, Phase 4, Open-label, Safety Surveillance, CP690550, Xeljanz, oral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1
Arm Type
Experimental
Arm Title
Treatment Arm 2
Arm Type
Experimental
Arm Title
Treatment Arm 3
Arm Type
Active Comparator
Arm Description
TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
Intervention Type
Drug
Intervention Name(s)
tofacitinib
Intervention Description
Oral tablet, 5 mg BID
Intervention Type
Drug
Intervention Name(s)
tofacitinib
Intervention Description
Oral tablet, 10 mg BID
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Pre-filled syringe, 40 mg subcutaneous injection, every other week
Intervention Type
Biological
Intervention Name(s)
etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
Pre-filled syringe, 50 mg subcutaneous injection, every week
Primary Outcome Measure Information:
Title
Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
Description
Incidence rate (number of participants with event per 100 participant year [PY]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
Description
MACE included the cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke of any classification, including reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Secondary Outcome Measure Information:
Title
Incidence Rate of Non-fatal Stroke
Description
Non-fatal stroke included reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Incidence Rate of Non-fatal Myocardial Infarction
Description
Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
Description
Opportunistic infections (OI) were reviewed and adjudicated by the opportunistic infection review committee (OIRC). Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Incidence Rate of Adjudicated Hepatic Events
Description
Hepatic events (adjudicated) included drug-induced liver injury (DILI) - probable, highly likely and definite, DILI - listed separately, DILI - cases meeting classification and severity, participants with elevations of transaminase levels greater than (>) 1* upper limit of normal (ULN), greater than or equal to (>=) 3*ULN, >=5*ULN (based on laboratory values). Incidence rate was the total number of participants with admissible events divided by total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was minimum of The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
Description
Cardiovascular events (adjudicated) were death (coronary and non-coronary), MI, all coronary revascularization, unstable angina, new ischemic heart disease, stroke (fatal and non-fatal), transient ischemic attack (TIA), congestive heart failure (CHF), peripheral arterial vascular disease (PAVD), deep vein thrombosis, pulmonary embolism, arterial embolism, arterial thrombosis. Incidence rate was total number of participants with admissible events divided by total (for all qualifying participants) time at risk for cohort/treatment group of interest. Risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. Last contact date was maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). In case of death, last contact date was death date. First events counted within RP. Participant did not have an event or had an event outside risk period were censored at end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
AE was any untoward medical occurrence post treatment; event need not necessarily had causal relationship with treatment or usage. SAE: any untoward medical occurrence at any dose: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly. TEAE: event that occurred for first time during effective duration of treatment and not seen prior to start of treatment or event seen prior to start of treatment but increase in severity during treatment. Risk period (RP) for AE: minimum of last contact date or last study treatment dose date+28 days. RP for SAEs: last contact date. Last contact date was maximum: AE start, AE stop, last study visit, withdrawal and telephone contact. In case of death, last contact was death date. First events counted within RP. Participant did not have event or had event outside risk period were censored at end of RP.
Time Frame
AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months)
Title
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Description
Clinically significant laboratory abnormalities: Hematology: hemoglobin, hematocrit, erythrocytes with primary criteria as less than [<] 0.8* lower limit of normal [LLN]), platelets (<0.5* LLN; >1.75* ULN), leukocytes (<0.6*LLN; >1.5*ULN), lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes (<0.8*LLN; >1.2*ULN), eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes (>1.2*ULN); urinalysis: urine glucose, urine protein, urine hemoglobin, and leukocyte esterase (>=1); chemistry: bilirubin, indirect bilirubin (>1.5*ULN) aspartate aminotransferase, alanine aminotransferase (>3.0*ULN), creatinine, triglycerides, cholesterol (>1.3*ULN) and HDL cholesterol (<0.8*LLN). Risk period (RP) was minimum of last contact date or last study treatment dose date+28 days. Last contact date was (date of death or maximum of dates: AE start, AE stop, last study visit, withdrawal, telephone contact). Participants without event or event outside RP were censored at end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Incidence Rate of Adjudicated All-Cause Deaths
Description
All-cause death was defined as the death due to any cause during the course of study. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Incidence rate of all-cause deaths (adjudicated by Adjudication Committee) was reported in this outcome measure. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication
Description
Number of participants who permanent or temporary discontinued study medication due to any AE, treatment related AEs, Coronavirus disease 2019 (COVID 19) related AEs, and herpes zoster were reported. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 28 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Time Frame
Baseline up to last contact date (maximum up to 72 months)
Title
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Description
DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (milligrams per liter [mg/L]) and patient's global assessment of disease activity (PtGA) on a 100 mm Visual Analog Scale (VAS) (scores ranging from 0 millimeter [mm] [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root.
Time Frame
Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Title
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Description
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and physician's global assessment of health (PhyGA) both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
Time Frame
Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Title
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Description
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
Time Frame
Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Title
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria
Description
ACR-EULAR Boolean-based definition of remission participant must satisfy all of the following: TJC28 <=1, SJC28 <=1, CRP <=10 mg/L, PtGA on a 0-100 mm scale, higher scores indicate greater affection due to disease activity.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3
Description
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8
Description
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11
Description
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/L). SDAI total score ranges from 0 to 86 with higher score indicating greater disease activity. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity. SDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10 + CRP/10.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10
Description
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PhyGA both assessed on a 0 to 100 mm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76 with higher score indicating greater disease activity. CDAI <=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity. CDAI = (28TJC) + (28SJC) + PhyGA/10 + PtGA/10.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2
Description
DAS28 is a measure of disease activity in participants with rheumatoid arthritis based on a 28-joint assessment. DAS28-4 (CRP) was calculated from number of painful joints out of 28 joints (TJC28) and number of swollen joints out of 28 joints (SJC28), CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (CRP) score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 indicates low disease activity and > 3.2 to <=5.1 indicates moderate disease activity, >5.1 indicates high disease activity, and DAS28-4 (CRP) < 2.6 indicates remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
Description
ACR20 response is a >= 20% improvement in TJC (28) and SJC (28) and >=20% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Number of Participants With an American College of Rheumatology 50% (ACR50) Response
Description
ACR50 response is a >= 50% improvement in TJC (28) and SJC (28) and >=50% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Number of Participants With an American College of Rheumatology 70% (ACR70) Response
Description
ACR70 response is a >= 70% improvement in TJC (28) and SJC (28) and >=70% improvement in 3 of the 5 remaining ACR-core criteria: 1) PGA of arthritis, 2) PtGA of arthritis, 3) participant's assessment of arthritis pain, 4) participant's assessment of functional disability by HAQ-DI, and 5) CRP (mg/L) at each visit. PGA: physician's global assessment of arthritis on VAS, 0 (very well) to 100 mm (worst arthritis), higher scores=worse condition. PtGA: participant's global assessment of arthritis on VAS, 0 mm (very well) to 100 mm (worst arthritis condition), higher scores = worse condition. Participant's assessment of arthritis pain: assessed on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (unable to do), higher score=more disability.
Time Frame
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Title
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Description
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time Frame
Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe rheumatoid arthritis Taking methotrexate without adequate control of symptoms Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease) Exclusion Criteria: Current or recent infection Clinically significant laboratory abnormalities Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-7201
Country
United States
Facility Name
Rheumatology Associates of North Alabama, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinical and Translational Research Center of Alabama, PC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Southern Arizona VA Health Care System (SAVAHCS)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University of Arizona Clinical and Translational Science Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
CHI St. Vincent Medical Group Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Arthritis And Rheumatism Associates LLC
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Med Investigations, Inc.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
University of California, San Diego (UCSD)- Perlman Ambulatory Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
ProHealth Partners
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Keck Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
California Medical Research Associates Inc
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Medvin Clinical Research
City
Placentia
State/Province
California
ZIP/Postal Code
92870
Country
United States
Facility Name
Sierra Rheumatology, Inc.
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
San Diego Arthritis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Dr. Orrin M. Troum, Md And Medical Associates
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Robin K. Dore M.D., Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Medvin Clinical Research
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Desert Valley Medical Group
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Arthritis Associates and Osteoporosis Center of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
RASF-Clinical Research Center, Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Arthritis & Rheumatism Associates (Private Practice)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Florida Clinical Research Group (Administrative Office)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Dr.Robert W. Levin MDOffice of
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
International Medical Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Centre for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
University of Florida - Rheumatology at ACC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida College of Medicine, Jacksonville - Rheumatology Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Doctors Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Center for Arthritis and Rheumatic Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Advanced Clinical Research of Orlando
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Arthritis & osteoporosis treatment center,PA
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Rheumatology Associates of Central Florida, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Consultants, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Arthritis Center, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Arthritis Research of Florida, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Advanced Urgent Care
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
USF Health Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Arthritis and Rheumatology of GA, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medical Associates of North Georgia - Rheumatology
City
Canton
State/Province
Georgia
ZIP/Postal Code
30115
Country
United States
Facility Name
Office of Jefrey D. Lieberman, MD, PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Coeur D'Alene Arthritis Clinic
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Diagnostic Rheumatology and Research PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
MidWest Clinical Research, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
Arthritis and Diabetes Clinic, Inc.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Klein & Associates, M.D.,P.A.
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Arthritis Treatment Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Klein & Associates, MD, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Phase III Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
UMass Memorial Medical Center, Memorial Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Bronson Healthcare Group
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
Facility Name
Bronson Rheumatology Specialists
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Jasper Clinic, Inc.
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
June DO,PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Shores Rheumatology P.C.
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
St. Paul Rheumatology, PA
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Center for Diagnostic Imaging
City
Mendota Heights
State/Province
Minnesota
ZIP/Postal Code
55118
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Kansas City Internal Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Westroads Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nevada School of Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Steinberg Diagnostics
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
EKSAKTI, LLC (dba: Eksakti Clinical Research)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Arthritis Center Of Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Nashua Rheumatology
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Summit Medical Group
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
Weill Cornell Physicians at Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Northwell Health Division of Rheumatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Langone Rheumatology Associates Long Island.
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
EmergeOrtho,P.A.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
PMG Research of Hickory LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Frycare outpatient imaging Center
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Carolina Arthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
St. Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Trinity Health Center - Medical Arts
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Medical Research Foundation (OMRF)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
The Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
UPMC Arthritis and Autoimmunity Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Lupus Center of Excellence
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
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
Rheumatology Associates, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Innovative Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Piedmont Arthritis Clinic, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Articluaris Healthcare Group d/b/a ACME Research
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Rheumatology Consultants, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Dr. Ramesh C. Gupta MD, Office of
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Center For Inflammatory Disease
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Amarillo Center for Clinical Research, Ltd.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Trinity Universal Research Associates, Inc
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Baylor Scott and White Research Institute / Arthritis Care and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Arthritis Centers of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Accurate Clinical Management, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Rheumatic Disease Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Houston Institute for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Accurate Clinical Management, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Medical Center Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Arthritis and Osteoporosis Associates, LLP
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Southwest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Trinity Universal Research Associates, Inc.
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
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
Center for Arthritis and Rheumatic Diseases, P.C.
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
OMI- Organizacion Medica de Investigacion
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
City
C.a.b.a.
State/Province
Caba
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Sanatorio Parque S.A y Consultorios Externos Asociados
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Consultorios Reumatologicos Pampa.
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
CIER - Centro de Investigaciones en Enfermedades Reumaticas
City
Caba
ZIP/Postal Code
C1055AAF
Country
Argentina
Facility Name
Centro Privado de Medicina Familiar - Mindout Research S.R.L.
City
Caba
ZIP/Postal Code
C1417EYG
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba S.A.
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Sanatorio Parque S.A y Consultorios Externos Asociados
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
I.A.R.I. Instituto de Asistencia Reumatologica Integral - Sede IMAC
City
San Isidro
ZIP/Postal Code
1643
Country
Argentina
Facility Name
CER San Juan
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
St. Vincent's Hospital (Melbourne)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Health - Repatriation Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Austin Repatriation Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
RK Will Pty Ltd
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
SER - Servicos Especializados em Reumatologia da Bahia
City
Salvador
State/Province
BA
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo
City
Vitoria
State/Province
Espírito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
City
Juiz De Fora
State/Province
MG
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Hospital das Clinicas Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
EDUMED - Educacao em Saude SS Ltda
City
Curitiba
State/Province
PR
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
CCBR Brasil - Centro de Pesquisas e Analises Clinicas LTDA
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
City
São Jose do Rio Preto
State/Province
SAO Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Clinica Medica Bonfliglioli Ltda.
City
Campinas
State/Province
SP
ZIP/Postal Code
13015-001
Country
Brazil
Facility Name
CPCLin - Centro de Pesquisas Clinicas Ltda. / Clinica Dr. Freddy Goldberg Eliaschewitz LTDA EPP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
AACD- Lar Escola\ Associacao de Assistencia a Crianca Deficiente
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Instituto de Assistencia Medica do Hospital do Servidor Publico Estadual
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Fundacao Faculdade de Medicina MECMPAS - Hospital das Clinicas da FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05652-900
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Rio Grande De Sul
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
UMBAL "Dr Georgi Stranski" EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MBAL Eurohospital Plovdiv OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MBAL RUSe AD,
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMBAL Sveti Ivan Rilski" EAD
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
MBAL Sveta Marina EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Rheumatology Research Associates
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
PerCuro Clinical Research Limited
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Medicine Professional Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Clinical Research and Arthritis Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X2C9
Country
Canada
Facility Name
Centre de Rhumatologie de l'Est du Quebec
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 8W1
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Prosalud
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7510047
Country
Chile
Facility Name
Centro Medico de Reumatologia Ltda.
City
Temuco
State/Province
Region DE LA Araucania
ZIP/Postal Code
4790928
Country
Chile
Facility Name
Centro de Investigacion Clinica Universidad Catolica (CICUC)
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8330034
Country
Chile
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Centro Integral de Reumatologia REUMALAB S.A.S.
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
City
Bogota D.C.
State/Province
Cundinamarca
ZIP/Postal Code
112201
Country
Colombia
Facility Name
Centro de Investigaciones Clinica del Country
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Preventive Care S.A.S.
City
Chia
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Servimed S.A.S
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Vesalion, s.r.o.
City
Ostrava
State/Province
Czech Republic
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Mediscan Group, s.r.o.
City
Praha 11
State/Province
Czech Republic
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Revmacentrum MUDr. Mostera, s.r.o.
City
Brno - Zidenice
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
REVMACLINIC s.r.o.
City
Brno
ZIP/Postal Code
61141
Country
Czechia
Facility Name
Revmatologie, s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Artroscan, s.r.o.
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Revmatologicky ustav.
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Revmatologicka Ambulance
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
PV - MEDICAL s.r.o.
City
Zlin
ZIP/Postal Code
76001
Country
Czechia
Facility Name
Helsingin yliopistollinen keskussairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Kiljavan Laaketutkimus Oy
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Laakarikeskus Aava Hyvinkaan Pipetti
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Chai Wan
State/Province
HKG
Country
Hong Kong
Facility Name
The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Barzilai Medical Center - Rheumatology Outpatient Clinic
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Beer Yaacov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Bnai Zion Medical Center Rheumatology Unit
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassah Medical Center - Hebrew University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Istishari Hospital
City
Amman
ZIP/Postal Code
11184
Country
Jordan
Facility Name
King Abdullah University Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Facility Name
Hotel Dieu de France Hospital
City
Achrafieh
State/Province
Beirut
Country
Lebanon
Facility Name
Ain Wazein Hospital
City
Lebanon
Country
Lebanon
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Selayang, Department of Medicine
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Consultorio de Reumatologia
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Centro Integral en Reumatologia SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Centro de Investigacion Clinica de Morelia. S.C
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58070
Country
Mexico
Facility Name
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58249
Country
Mexico
Facility Name
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Facility Name
Unidad Reumatologica Las Americas S.C.P.
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigacion y Biomedicina de Chihuahua SC
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
City
Ciudad de Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Unidad de Investigaciones Reumatologicas
City
San Luis Potosi
ZIP/Postal Code
78290
Country
Mexico
Facility Name
Medical Center Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Universitair Medisch Centrum (UMC) Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Middlemore Hospital Middlemore Clinical Trials Trust
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Rheumatology Clinic, Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Timaru Hospital
City
Timaru
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Centro de Investigacion Clinica Trujillo E.I.R.L. Clinica Peruana Americana
City
Trujillo
State/Province
LA Libertad
ZIP/Postal Code
13001
Country
Peru
Facility Name
Centro de lnvestigacion de la Red Asistencial del Hospital Nacional ESSALUD Carlos Alberto Seguin E.
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
ACQ MEDIC S.A.C. - Centro de Investigacion Clinica Inmunoreumatologia
City
Lima
ZIP/Postal Code
11
Country
Peru
Facility Name
Unidad de Investigacion de la Clinica Internacional - Clinica Internacional
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
ABK REUMA S.R.L. de Medicentro Biociencias- BIO CIENCIAS PERU S.R.L.
City
Lima
ZIP/Postal Code
21
Country
Peru
Facility Name
Instituto Peruano del Hueso y la Articulacion - Instituto Peruano del Hueso y la Articulacion S.A.C.
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Investigaciones en Reumatologia - Centro Medico Corpac
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Investigaciones Clinicas S.A.C.
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Centro de Investigacion de Reumatologia - Clinica San Borja
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Centro de Investigacion en Salud - Centro de Excelencia en Reumatologia
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
NZOZ Lecznica MAK-MED
City
Nadarzyn
State/Province
Mazowieckie
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Indywidualna Praktyka lekarska Dr hab. med. Anna Szczepańska - Szerej
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
PROFMEDICUS Sp. z o.o., Osrodek Badan Klinicznych
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Pomorskie Centrum Reumatologiczne im. Dr Jadwigi Titz-Kosko w Sopocie, Spolka. z o.o.
City
Sopot
ZIP/Postal Code
81-759
Country
Poland
Facility Name
KO-MED Centra Kliniczne Sp. zo.o.
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
NASZ LEKARZ Przychodnie Medyczne
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
City
Warsaw
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Synexus Polska Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-281
Country
Poland
Facility Name
NZOZ Biogenes Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
53-224
Country
Poland
Facility Name
Ponce Medical School Foundation, Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Fundacion de Investigaction de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the
City
St. Petersburg
State/Province
St.petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
SBHI City Clinical Hospital #4 of HD of Moscow
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
SBHI of Moscow City Clinical Hospital 1 n. a. N.I. Pirogov of the Healthcare Department of Moscow
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
SBIH of Nizhniy Novgorod region City Clinical Hospital #5 of Nizhniy Novgorod district
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution "Research Institute of Fundamental and
City
Novosibirsk
ZIP/Postal Code
630075
Country
Russian Federation
Facility Name
Consulting and Diagnostic Rheumatological Center Healthy Joints LLC
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
GBUZ RK Republic Hospital n. a. V.A. Baranov of the MoH & social development Of The Karelia Republic
City
Petrozavodsk
ZIP/Postal Code
185000
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Saint-Petersburg State Budget Healthcare Institution Consultative-diagnostic Center #85
City
St. Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
SBEI of HPE Ural State Medical University of the MoH of the RF
City
Yekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Municipal Budgetary Institution "Central City Clinical Hospital #6"
City
Yekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
ROMJAN s.r. o. , Specializovana Reumatologicka ambulancia
City
Bratislava - Petrzalka
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Nestatna reumatologicka ambulancia
City
Bratislava
ZIP/Postal Code
841 04
Country
Slovakia
Facility Name
AAGS, s.r.o., Reumatologicka ambulancia
City
Dunajska Streda
ZIP/Postal Code
929 01
Country
Slovakia
Facility Name
ECCLESIA s.r.o, Reumatologicka ambulancia
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
REUMACENTRUM s.r.o., Reumatologicka ambulancia
City
Partizanske
ZIP/Postal Code
958 01
Country
Slovakia
Facility Name
Reumex s.r.o
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Reuma-Global s.r.o., Reumatologicka ambulancia
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Greenacres Hospital
City
Port Elizabeth
State/Province
Eastern CAPE
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Wits Clinical Research Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Clinresco Centres ( Pty ) Ltd
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Jakaranda Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
St. Augustine's Hospital - Chelmsford Medical Centre 2
City
Durban
State/Province
Kwa-zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Tiervlei Trial Centre, Karl Bremer Hospital
City
Bellville, Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Arthritis Clinical Research Trials cc
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
University of Cape Town
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Winelands Medical Research Centre-
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hospital de Merida
City
Merida
State/Province
Badajoz
ZIP/Postal Code
06800
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Nuestra Senora de la Esperanza
City
Santiago de Compostela
State/Province
LA Coruna
ZIP/Postal Code
15705
Country
Spain
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Plato
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital De La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung City
State/Province
Taiwan (r.o.c)
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Changhua Christian Hospital
City
Changhua City
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Buddhist Dalin Tzu Chi General Hospital
City
Chia-Yi
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou Branch
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Medicine , Siriraj Hospital , Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Prince of Songkla University
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Adnan Menderes Universitesi Tip Fakultesi Hastanesi
City
Aydin
ZIP/Postal Code
09010
Country
Turkey
Facility Name
Gaziantep Universitesi Tip Fakultesi
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Izmir Tepecik Egitim ve Arastirma Hastanesi
City
Izmir
ZIP/Postal Code
35180
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi Hastanesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi Fiziksel Tip ve
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Cumhuriyet Universitesi Tip Fakultesi Hastanesi
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Poole Hospital, University Hospitals Dorset NHS Foundation Trust
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH152JB
Country
United Kingdom
Facility Name
Barking, Havering and Redbridge University Hospitals NHS Trust
City
Goodmayes
State/Province
Essex
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust-Cannock Chase Hospital
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Facility Name
Aintree University Hospital, Liverpool University Hospitals
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Clinical trials, Pharmacy Department, Aintree University Hospitals
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
University of Liverpool Academic Rheumatology Unit. Aintree University Hospital. Liverpool Universit
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Clinical Research Facility
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Pharmacy Department
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
36323490
Citation
Weitz JI, Szekanecz Z, Charles-Schoeman C, Vranic I, Sahin B, Paciga SA, Wang Z, Hyde C, Martin DA. Biomarkers to predict risk of venous thromboembolism in patients with rheumatoid arthritis receiving tofacitinib or tumour necrosis factor inhibitors. RMD Open. 2022 Nov;8(2):e002571. doi: 10.1136/rmdopen-2022-002571.
Results Reference
derived
PubMed Identifier
36137735
Citation
Charles-Schoeman C, Buch MH, Dougados M, Bhatt DL, Giles JT, Ytterberg SR, Koch GG, Vranic I, Wu J, Wang C, Kwok K, Menon S, Rivas JL, Yndestad A, Connell CA, Szekanecz Z. Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance. Ann Rheum Dis. 2023 Jan;82(1):119-129. doi: 10.1136/ard-2022-222259. Epub 2022 Sep 22.
Results Reference
derived
PubMed Identifier
35922124
Citation
Balanescu AR, Citera G, Pascual-Ramos V, Bhatt DL, Connell CA, Gold D, Chen AS, Sawyerr G, Shapiro AB, Pope JE, Schulze-Koops H. Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2022 Nov;81(11):1491-1503. doi: 10.1136/ard-2022-222405. Epub 2022 Aug 3. Erratum In: Ann Rheum Dis. 2023 Oct;82(10):e219.
Results Reference
derived
PubMed Identifier
35081280
Citation
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, Germino R, Menon S, Sun Y, Wang C, Shapiro AB, Kanik KS, Connell CA; ORAL Surveillance Investigators. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med. 2022 Jan 27;386(4):316-326. doi: 10.1056/NEJMoa2109927.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921133&StudyName=Safety%20Study%20Of%20tofacitinib%20Versus%20Tumor%20Necrosis%20Factor%20%28TNF%29%20Inhibitor%20In%20Subjects%20With%20Rheumatoid%20Arthritis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

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