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

July 21, 2021 updated by: Pfizer

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

4372

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 1428
        • Consultorios Reumatologicos Pampa.
      • Caba, Argentina, C1055AAF
        • CIER - Centro de Investigaciones en Enfermedades Reumaticas
      • Caba, Argentina, C1417EYG
        • Centro Privado de Medicina Familiar - Mindout Research S.R.L.
      • Cordoba, Argentina, 5016
        • Hospital Privado Centro Medico de Cordóba S.A.
      • Rosario, Argentina, 2000
        • Sanatorio Parque S.A y Consultorios Externos Asociados
      • San Isidro, Argentina, 1643
        • I.A.R.I. Instituto de Asistencia Reumatologica Integral - Sede IMAC
      • San Juan, Argentina, 5400
        • CER San Juan
    • Caba
      • Buenos Aires, Caba, Argentina, C1015ABO
        • OMI- Organización Médica de Investigación
      • C.a.b.a., Caba, Argentina, 1431
        • Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
    • Santa FE
      • Rosario, Santa FE, Argentina, 2000
        • Sanatorio Parque S.A y Consultorios Externos Asociados
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Centro Medico Privado de Reumatologia
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital (Melbourne)
      • Heidelberg, Victoria, Australia, 3081
        • Austin Repatriation Hospital
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
    • Western Australia
      • Victoria Park, Western Australia, Australia, 6100
        • RK Will Pty Ltd
      • Rio Grande De Sul, Brazil, 90560-030
        • Hospital Moinhos de Vento
      • Sao Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
    • BA
      • Salvador, BA, Brazil, 40150-150
        • SER - Servicos Especializados em Reumatologia da Bahia
    • Espírito Santo
      • Vitoria, Espírito Santo, Brazil, 29055-450
        • CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo
    • MG
      • Juiz De Fora, MG, Brazil, 36010-570
        • CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Hospital das Clinicas Universidade Federal de Minas Gerais
    • PR
      • Curitiba, PR, Brazil, 80440-080
        • EDUMED - Educação em Saùde SS Ltda
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22271-100
        • CCBR Brasil - Centro de Pesquisas e Analises Clinicas LTDA
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre - UFRGS
    • SAO Paulo
      • São Jose do Rio Preto, SAO Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
    • SP
      • Campinas, SP, Brazil, 13015-001
        • Clinica Medica Bonfliglioli Ltda.
      • Sao Paulo, SP, Brazil, 05652-900
        • Hospital Israelita Albert Einstein
      • Sao Paulo, SP, Brazil, 01244-030
        • CPCLin - Centro de Pesquisas Clinicas Ltda. / Clinica Dr. Freddy Goldberg Eliaschewitz LTDA EPP
      • Sao Paulo, SP, Brazil, 04032-060
        • AACD- Lar Escola\ Associacao de Assistencia a Crianca Deficiente
      • Sao Paulo, SP, Brazil, 04039-901
        • Instituto de Assistencia Medica do Hospital do Servidor Publico Estadual
      • Sao Paulo, SP, Brazil, 05403-900
        • Fundacao Faculdade de Medicina MECMPAS - Hospital das Clinicas da FMUSP
      • Pleven, Bulgaria, 5800
        • UMBAL "Dr Georgi Stranski" EAD
      • Plovdiv, Bulgaria, 4000
        • MBAL Eurohospital Plovdiv OOD
      • Ruse, Bulgaria, 7002
        • MBAL RUSe AD,
      • Sofia, Bulgaria, 1612
        • UMBAL Sveti Ivan Rilski" EAD
      • Varna, Bulgaria, 9010
        • MBAL Sveta Marina EAD
    • Alberta
      • Edmonton, Alberta, Canada, T5M 0H4
        • Rheumatology Research Associates
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • PerCuro Clinical Research Limited
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Medicine Professional Corporation
      • Windsor, Ontario, Canada, N8X2C9
        • Clinical Research and Arthritis Centre
    • Quebec
      • Rimouski, Quebec, Canada, G5L 8W1
        • Centre de Rhumatologie de l'Est du Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Centre De Recherche Musculo-Squelettique
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7510047
        • Prosalud
    • Region DE LA Araucania
      • Temuco, Region DE LA Araucania, Chile, 4790928
        • Centro Medico de Reumatologia Ltda.
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8330034
        • Centro de Investigacion Clinica Universidad Catolica (CICUC)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Centro Integral de Reumatologia REUMALAB S.A.S.
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Centro de Investigaciones Clinica del Country
      • Bogota D.C., Cundinamarca, Colombia, 112201
        • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
      • Chia, Cundinamarca, Colombia, 250001
        • Preventive Care S.A.S.
    • Santander
      • Bucaramanga, Santander, Colombia
        • Servimed S.A.S
      • Brno, Czechia, 61141
        • REVMACLINIC s.r.o.
      • Brno, Czechia, 638 00
        • Revmatologie, s.r.o.
      • Brno - Zidenice, Czechia, 615 00
        • Revmacentrum MUDr. Mostera, s.r.o.
      • Ostrava, Czechia, 722 00
        • Artroscan, s.r.o.
      • Praha 2, Czechia, 128 50
        • Revmatologicky ustav.
      • Praha 4, Czechia, 140 00
        • Revmatologicka ambulance
      • Zlin, Czechia, 76001
        • PV - MEDICAL s.r.o.
    • Czech Republic
      • Ostrava, Czech Republic, Czechia, 702 00
        • Vesalion, s.r.o.
      • Praha 11, Czech Republic, Czechia, 148 00
        • Mediscan Group, s.r.o.
      • Helsinki, Finland, 00290
        • Helsingin Yliopistollinen Keskussairaala
      • Hyvinkaa, Finland, 05800
        • Kiljavan Lääketutkimus Oy
      • Hyvinkaa, Finland, 05800
        • Laakarikeskus Aava Hyvinkaan Pipetti
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong, 999077
        • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
      • Shatin, Hong Kong
        • Prince of Wales Hospital
    • HKG
      • Chai Wan, HKG, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center - Rheumatology Outpatient Clinic
      • Beer Yaacov, Israel, 70300
        • Assaf Harofeh Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center Rheumatology Unit
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center - Hebrew University Hospital
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel-Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
      • Amman, Jordan, 11184
        • Istishari Hospital
      • Irbid, Jordan, 22110
        • King Abdullah University Hospital
      • Lebanon, Lebanon
        • Ain Wazein Hospital
    • Beirut
      • Achrafieh, Beirut, Lebanon
        • Hotel Dieu de France Hospital
    • Perak
      • Ipoh, Perak, Malaysia, 30990
        • Hospital Raja Permaisuri Bainun
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Hospital Selayang, Department of Medicine
      • Chihuahua, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua SC
      • Ciudad de Mexico, Mexico, 11850
        • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
      • San Luis Potosi, Mexico, 78213
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
      • San Luis Potosi, Mexico, 78290
        • Unidad de Investigaciones Reumatologicas
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 07760
        • Consultorio de Reumatologia
      • Mexico, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral en Reumatologia SA de CV
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
    • Michoacan
      • Morelia, Michoacan, Mexico, 58070
        • Centro de Investigacion Clinica de Morelia. S.C
      • Morelia, Michoacan, Mexico, 58249
        • Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80000
        • Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Unidad Reumatologica las Americas S.C.P.
      • Leeuwarden, Netherlands, 8934 AD
        • Medical Center Leeuwarden
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum (UMC) Utrecht
      • Auckland, New Zealand, 2025
        • Middlemore Hospital Middlemore Clinical Trials Trust
      • Hamilton, New Zealand, 3204
        • Rheumatology Clinic, Waikato Hospital
      • Timaru, New Zealand, 7910
        • Timaru Hospital
      • Wellington, New Zealand, 6021
        • Wellington Hospital
      • Arequipa, Peru, 04001
        • Centro de lnvestigacion de la Red Asistencial del Hospital Nacional ESSALUD Carlos Alberto Seguin E.
      • Lima, Peru, 11
        • ACQ MEDIC S.A.C. - Centro de Investigacion Clinica Inmunoreumatologia
      • Lima, Peru, 1
        • Unidad de Investigacion de la Clinica Internacional - Clinica Internacional
      • Lima, Peru, 21
        • ABK REUMA S.R.L. de Medicentro Biociencias- BIO CIENCIAS PERU S.R.L.
      • Lima, Peru, 27
        • Instituto Peruano del Hueso y la Articulacion - Instituto Peruano del Hueso y la Articulacion S.A.C.
      • Lima, Peru, 27
        • Investigaciones en Reumatologia - Centro Medico Corpac
      • Lima, Peru, 33
        • Investigaciones Clinicas S.A.C.
      • Lima, Peru, 41
        • Centro de Investigacion de Reumatologia - Clinica San Borja
      • Lima, Peru, 41
        • Centro de Investigacion en Salud - Centro de Excelencia en Reumatologia
    • LA Libertad
      • Trujillo, LA Libertad, Peru, 13001
        • Centro de Investigacion Clinica Trujillo E.I.R.L. Clinica Peruana Americana
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
      • Elblag, Poland, 82-300
        • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
      • Gdynia, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Lublin, Poland, 20-582
        • Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
      • Lublin, Poland, 20-022
        • Indywidualna Praktyka lekarska Dr hab. med. Anna Szczepańska - Szerej
      • Olsztyn, Poland, 10-357
        • PROFMEDICUS Sp. z o.o., Osrodek Badan Klinicznych
      • Poznan, Poland, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
      • Sopot, Poland, 81-759
        • Pomorskie Centrum Reumatologiczne im. Dr Jadwigi Titz-Kosko w Sopocie, Spolka. z o.o.
      • Staszow, Poland, 28-200
        • KO-MED Centra Kliniczne Sp. zo.o.
      • Torun, Poland, 87-100
        • Nasz Lekarz Przychodnie Medyczne
      • Warsaw, Poland, 02-118
        • Rheuma Medicus Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 01-868
        • Centrum Medyczne Pratia Warszawa
      • Wroclaw, Poland, 50-281
        • Synexus Polska Sp. z o.o.
      • Wroclaw, Poland, 53-224
        • NZOZ Biogenes Sp. z o.o.
    • Mazowieckie
      • Nadarzyn, Mazowieckie, Poland, 05-830
        • NZOZ Lecznica MAK-MED
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-351
        • ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation, Inc.
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigaction de Diego
      • Moscow, Russian Federation, 115093
        • SBHI City Clinical Hospital #4 of HD of Moscow
      • Moscow, Russian Federation, 119049
        • SBHI of Moscow City Clinical Hospital 1 n. a. N.I. Pirogov of the Healthcare Department of Moscow
      • Nizhniy Novgorod, Russian Federation, 603005
        • SBIH of Nizhniy Novgorod region City Clinical Hospital #5 of Nizhniy Novgorod district
      • Novosibirsk, Russian Federation, 630075
        • Federal State Budgetary Scientific Institution "Research Institute of Fundamental and
      • Novosibirsk, Russian Federation, 630099
        • Consulting and Diagnostic Rheumatological Center Healthy Joints LLC
      • Petrozavodsk, Russian Federation, 185000
        • GBUZ RK Republic Hospital n. a. V.A. Baranov of the MoH & social development Of The Karelia Republic
      • Smolensk, Russian Federation, 214019
        • Federal State Budgetary Educational Institution of Higher Education
      • St. Petersburg, Russian Federation, 198260
        • Saint-Petersburg State Budget Healthcare Institution Consultative-diagnostic Center #85
      • Yekaterinburg, Russian Federation, 620028
        • SBEI of HPE Ural State Medical University of the MoH of the RF
      • Yekaterinburg, Russian Federation, 620149
        • Municipal Budgetary Institution "Central City Clinical Hospital #6"
    • St.petersburg
      • St. Petersburg, St.petersburg, Russian Federation, 197706
        • Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the
      • Bratislava, Slovakia, 841 04
        • Neštátna Reumatologická Ambulancia
      • Bratislava - Petrzalka, Slovakia, 851 01
        • ROMJAN s.r. o. , Specializovana Reumatologicka ambulancia
      • Dunajska Streda, Slovakia, 929 01
        • AAGS, s.r.o., Reumatologicka ambulancia
      • Nove Zamky, Slovakia, 940 01
        • ECCLESIA s.r.o, Reumatologicka ambulancia
      • Partizanske, Slovakia, 958 01
        • REUMACENTRUM s.r.o., Reumatologicka ambulancia
      • Rimavska Sobota, Slovakia, 979 01
        • Reumex s.r.o
      • Trnava, Slovakia, 91701
        • Reuma-Global s.r.o., Reumatologicka ambulancia
      • Stellenbosch, South Africa, 7600
        • Winelands Medical Research Centre-
    • Eastern CAPE
      • Port Elizabeth, Eastern CAPE, South Africa, 6045
        • Greenacres Hospital
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • WITS Clinical Research Site
      • Kempton Park, Gauteng, South Africa, 1619
        • Clinresco Centres ( Pty ) Ltd
      • Pretoria, Gauteng, South Africa, 0084
        • Emmed Research
      • Pretoria, Gauteng, South Africa, 0002
        • Jakaranda Hospital
    • Kwa-zulu Natal
      • Durban, Kwa-zulu Natal, South Africa, 4001
        • St. Augustine's Hospital - Chelmsford Medical Centre 2
    • Western CAPE
      • Bellville, Cape Town, Western CAPE, South Africa, 7530
        • Tiervlei Trial Centre, Karl Bremer Hospital
      • Cape Town, Western CAPE, South Africa, 7500
        • Panorama Medical Centre
      • Cape Town, Western CAPE, South Africa, 7405
        • Arthritis Clinical Research Trials cc
      • Cape Town, Western CAPE, South Africa, 7925
        • University of Cape Town
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08006
        • Hospital Plató
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Malaga, Spain, 29009
        • Hospital Regional Universitario de Málaga
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen De La Macarena
    • Badajoz
      • Merida, Badajoz, Spain, 06800
        • Hospital de Mérida
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15705
        • Hospital Nuestra Señora de La Esperanza
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital Universitario de Cruces
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital Universitario de Basurto
      • Changhua City, Taiwan, 500
        • Changhua Christian Hospital
      • Chia-Yi, Taiwan, 62247
        • Buddhist Dalin Tzu Chi General Hospital
      • Taichung City, Taiwan
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Medical Foundation - Linkou Branch
    • Taiwan (r.o.c)
      • Taichung City, Taiwan (r.o.c), Taiwan, 40447
        • China Medical University Hospital
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital, Mahidol University
      • Bangkok, Thailand, 10700
        • Faculty of Medicine , Siriraj Hospital , Mahidol University
      • Chiang Mai, Thailand, 50200
        • Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,Chiang Mai University
      • Songkhla, Thailand, 90110
        • Prince of Songkla University
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Turkey, 06100
        • Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi
      • Aydin, Turkey, 09010
        • Adnan Menderes Universitesi Tip Fakultesi Hastanesi
      • Gaziantep, Turkey, 27310
        • Gaziantep Universitesi Tip Fakultesi
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Izmir, Turkey, 35180
        • Izmir Tepecik Egitim ve Arastirma Hastanesi
      • Kocaeli, Turkey, 41380
        • Kocaeli Universitesi Tip Fakultesi Hastanesi
      • Samsun, Turkey, 55200
        • Ondokuz Mayis Universitesi Tip Fakultesi Fiziksel Tip ve
      • Sivas, Turkey, 58140
        • Cumhuriyet Universitesi Tip Fakultesi Hastanesi
      • Cannock, United Kingdom, WS11 5XY
        • The Royal Wolverhampton NHS Trust-Cannock Chase Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital, Liverpool University Hospitals
      • Liverpool, United Kingdom, L9 7AL
        • Clinical trials, Pharmacy Department, Aintree University Hospitals
      • Liverpool, United Kingdom, L9 7AL
        • University of Liverpool Academic Rheumatology Unit. Aintree University Hospital. Liverpool Universit
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Clinical Research Facility
      • North Shields, United Kingdom, NE29 8NH
        • Northumbria Healthcare NHS Foundation Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • Pharmacy Department
    • Dorset
      • Poole, Dorset, United Kingdom, BH152JB
        • Poole Hospital, University Hospitals Dorset NHS Foundation Trust
    • Essex
      • Goodmayes, Essex, United Kingdom, IG3 8YB
        • Barking, Havering and Redbridge University Hospitals NHS Trust
    • Alabama
      • Birmingham, Alabama, United States, 35294-7201
        • University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama, PC
      • Tuscaloosa, Alabama, United States, 35406
        • Clinical and Translational Research Center of Alabama, PC
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Clinical and Translational Science Research Center
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System (SAVAHCS)
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • CHI St. Vincent Medical Group Hot Springs
      • Jonesboro, Arkansas, United States, 72401
        • Arthritis And Rheumatism Associates LLC
    • California
      • Covina, California, United States, 91722
        • Medvin Clinical Research
      • Fair Oaks, California, United States, 95628
        • Med Investigations, Inc.
      • Huntington Beach, California, United States, 92646
        • Talbert Medical Group
      • La Jolla, California, United States, 92037
        • University of California, San Diego (UCSD)- Perlman Ambulatory Clinic
      • Long Beach, California, United States, 90806
        • Valerius Medical Group and Research Center of Greater Long Beach, Inc.
      • Long Beach, California, United States, 90808
        • ProHealth Partners
      • Los Angeles, California, United States, 90033
        • Keck Medicine of USC
      • Northridge, California, United States, 91324
        • California Medical Research Associates Inc
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Placentia, California, United States, 92870
        • Medvin Clinical Research
      • Roseville, California, United States, 95661
        • Sierra Rheumatology, Inc.
      • San Diego, California, United States, 92108
        • San Diego Arthritis Medical Clinic
      • Santa Monica, California, United States, 90404
        • Dr. Orrin M. Troum, Md And Medical Associates
      • Torrance, California, United States, 90509
        • Harbor Ucla Medical Center
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
      • Tustin, California, United States, 92780
        • Robin K. Dore M.D., Inc.
      • Van Nuys, California, United States, 91405
        • Medvin Clinical Research
      • Ventura, California, United States, 93003
        • Ventura Clinical Trials
      • Victorville, California, United States, 92395
        • Desert Valley Medical Group
      • Whittier, California, United States, 90602
        • Medvin Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Arthritis Associates and Osteoporosis Center of Colorado Springs
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
    • Florida
      • Boca Raton, Florida, United States, 33486
        • RASF-Clinical Research Center, Inc
      • Brandon, Florida, United States, 33511
        • Bay Area Arthritis and Osteoporosis
      • Clearwater, Florida, United States, 33756
        • Arthritis & Rheumatism Associates (Private Practice)
      • Clearwater, Florida, United States, 33759
        • Florida Clinical Research Group (Administrative Office)
      • Clearwater, Florida, United States, 33765
        • Dr.Robert W. Levin MDOffice of
      • Daytona Beach, Florida, United States, 32117
        • International Medical Research
      • Fort Lauderdale, Florida, United States, 33309
        • Centre for Rheumatology, Immunology and Arthritis
      • Jacksonville, Florida, United States, 32207
        • University of Florida College of Medicine, Jacksonville - Rheumatology Research
      • Jacksonville, Florida, United States, 32207
        • University of Florida - Rheumatology at ACC
      • Miami, Florida, United States, 33145
        • Doctors Research Institute
      • Miami, Florida, United States, 33173
        • Center for Arthritis and Rheumatic Diseases
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
      • Ocoee, Florida, United States, 34761
        • Advanced Clinical Research of Orlando
      • Orange Park, Florida, United States, 32073
        • Arthritis & osteoporosis treatment center,PA
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida, PA
      • Orlando, Florida, United States, 32810
        • Omega Research Consultants, LLC
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Research Of Florida, Inc.
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center, Inc.
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Port Orange, Florida, United States, 32127
        • Advanced Urgent Care
      • Tampa, Florida, United States, 33612
        • USF Health Morsani Center For Advanced Healthcare
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Arthritis and Rheumatology of GA, P.C.
      • Canton, Georgia, United States, 30115
        • Medical Associates of North Georgia - Rheumatology
      • Decatur, Georgia, United States, 30033
        • Office of Jefrey D. Lieberman, MD, PC
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Coeur D'Alene Arthritis Clinic
    • Illinois
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Diagnostic Rheumatology and Research PC
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Midwest Clinical Research, LLC
      • Wichita, Kansas, United States, 67205-1138
        • Professional Research Network of Kansas, LLC
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Arthritis and Diabetes Clinic, Inc.
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein & Associates, M.D.,P.A.
      • Frederick, Maryland, United States, 21702
        • Arthritis Treatment Center
      • Hagerstown, Maryland, United States, 21740
        • Klein & Associates, MD, PA
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase Iii Clinical Research
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center, Memorial Campus
    • Michigan
      • Battle Creek, Michigan, United States, 49015
        • Bronson Healthcare Group
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
      • Kalamazoo, Michigan, United States, 49008
        • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
      • Kalamazoo, Michigan, United States, 49007
        • Jasper Clinic, Inc.
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Rheumatology Specialists
      • Lansing, Michigan, United States, 48910
        • June DO,PC
      • Saint Clair Shores, Michigan, United States, 48081
        • Shores Rheumatology P.C.
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology, PA
      • Mendota Heights, Minnesota, United States, 55118
        • Center for Diagnostic Imaging
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Kansas City Internal Medicine
      • Springfield, Missouri, United States, 65810
        • Clinvest Research, LLC
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institute
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC
      • Omaha, Nebraska, United States, 68114
        • Westroads Clinical Research, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada School of Medicine
      • Las Vegas, Nevada, United States, 89109
        • Steinberg Diagnostics
      • Las Vegas, Nevada, United States, 89128
        • EKSAKTI, LLC (dba: Eksakti Clinical Research)
      • Reno, Nevada, United States, 89502
        • Arthritis Center of Reno
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Nashua Rheumatology
    • New Jersey
      • Clifton, New Jersey, United States, 07012
        • Summit Medical Group
    • New York
      • Brooklyn, New York, United States, 11201
        • Weill Cornell Physicians At Brooklyn Heights
      • Great Neck, New York, United States, 11021
        • Northwell Health Division of Rheumatology
      • Lake Success, New York, United States, 11042
        • NYU Langone Rheumatology Associates Long Island.
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • EmergeOrtho,P.A.
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
      • Hickory, North Carolina, United States, 28602
        • PMG Research of Hickory, LLC
      • Hickory, North Carolina, United States, 28601
        • PMG Research of Hickory LLC
      • Hickory, North Carolina, United States, 28602
        • Frycare outpatient imaging Center
      • Statesville, North Carolina, United States, 28625
        • PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • St. Alexius Medical Center
      • Minot, North Dakota, United States, 58701
        • Trinity Health Center - Medical Arts
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Rheumatic Disease Study Group, Inc.
      • Dayton, Ohio, United States, 45417
        • STAT Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation (OMRF)
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Philadelphia, Pennsylvania, United States, 19152
        • The Arthritis Group
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Lupus Center of Excellence
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Arthritis and Autoimmunity Clinic
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Rheumatology Associates, P.A.
      • Greenville, South Carolina, United States, 29601
        • Innovative Clinical Research, LLC
      • Greenville, South Carolina, United States, 29601
        • Piedmont Arthritis Clinic, PA
      • Orangeburg, South Carolina, United States, 29118
        • Articluaris Healthcare Group d/b/a ACME Research
      • Summerville, South Carolina, United States, 29486
        • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants, PLLC
      • Memphis, Tennessee, United States, 38119
        • Dr. Ramesh C. Gupta MD, Office of
      • Nashville, Tennessee, United States, 37203
        • Center For Inflammatory Disease
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research, Ltd.
      • Austin, Texas, United States, 78731
        • Austin Regional Clinic
      • Carrollton, Texas, United States, 75007
        • Trinity Universal Research Associates, Inc
      • Cypress, Texas, United States, 77429
        • Pioneer Research Solutions, Inc.
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Arthritis Centers of Texas
      • Dallas, Texas, United States, 75231
        • Baylor Scott and White Research Institute / Arthritis Care and Research Center
      • Houston, Texas, United States, 77084
        • Accurate Clinical Management, LLC
      • Houston, Texas, United States, 77004
        • Rheumatic Disease Clinical Research Center
      • Houston, Texas, United States, 77034
        • Accurate Clinical Research, Inc.
      • Houston, Texas, United States, 77074
        • Houston Institute For Clinical Research
      • Houston, Texas, United States, 77004
        • Accurate Clinical Management, LLC
      • Houston, Texas, United States, 77089
        • Medical Center Research, LLC
      • League City, Texas, United States, 77573
        • Accurate Clinical Research, Inc.
      • Lubbock, Texas, United States, 79424
        • Arthritis and Osteoporosis Associates, LLP
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research, LLC
      • Plano, Texas, United States, 75024
        • Trinity Universal Research Associates, Inc.
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis and Rheumatic Diseases, PC
      • Suffolk, Virginia, United States, 23435
        • Center for Arthritis and Rheumatic Diseases, P.C.
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Rheumatic Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Arm 1
Oral tablet, 5 mg BID
Oral tablet, 10 mg BID
EXPERIMENTAL: Treatment Arm 2
Oral tablet, 5 mg BID
Oral tablet, 10 mg BID
ACTIVE_COMPARATOR: Treatment Arm 3
TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
Pre-filled syringe, 40 mg subcutaneous injection, every other week
Other Names:
  • Humira
Pre-filled syringe, 50 mg subcutaneous injection, every week
Other Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Non-fatal Stroke
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Non-fatal Myocardial Infarction
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Hepatic Events
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
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.
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)
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated All-Cause Deaths
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication
Time Frame: Baseline up to last contact date (maximum up to 72 months)
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.
Baseline up to last contact date (maximum up to 72 months)
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
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
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.
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
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
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
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.
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
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
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
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.
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
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria
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
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.
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
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3
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
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.
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
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8
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
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.
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
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11
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
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.
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
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=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
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.
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
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2
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
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.
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
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
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
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.
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
Number of Participants With an American College of Rheumatology 50% (ACR50) Response
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
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.
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
Number of Participants With an American College of Rheumatology 70% (ACR70) Response
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
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.
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
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
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
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.
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

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2014

Primary Completion (ACTUAL)

July 22, 2020

Study Completion (ACTUAL)

July 22, 2020

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (ESTIMATE)

March 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

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Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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