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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092467
• Other study ID #: A3921133
• Secondary ID: 2013-003177-99
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2014
• Est. completion date: July 22, 2020

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4372
• Est. completion date: July 22, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Necrosis

Intervention

Drug:
• tofacitinib
Oral tablet, 5 mg BID
• tofacitinib
Oral tablet, 10 mg BID

Biological:
• adalimumab
Pre-filled syringe, 40 mg subcutaneous injection, every other week
• etanercept
Pre-filled syringe, 50 mg subcutaneous injection, every week

Locations

Country	Name	City	State
Argentina	Consultorios Reumatologicos Pampa.	Buenos Aires
Argentina	OMI- Organizacion Medica de Investigacion	Buenos Aires	Caba
Argentina	Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)	C.a.b.a.	Caba
Argentina	Centro Privado de Medicina Familiar - Mindout Research S.R.L.	Caba
Argentina	CIER - Centro de Investigaciones en Enfermedades Reumaticas	Caba
Argentina	Hospital Privado Centro Medico de Cordoba S.A.	Cordoba
Argentina	Sanatorio Parque S.A y Consultorios Externos Asociados	Rosario
Argentina	Sanatorio Parque S.A y Consultorios Externos Asociados	Rosario	Santa FE
Argentina	I.A.R.I. Instituto de Asistencia Reumatologica Integral - Sede IMAC	San Isidro
Argentina	CER San Juan	San Juan
Argentina	Centro Medico Privado de Reumatologia	San Miguel de Tucuman	Tucuman
Australia	St. Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	Austin Repatriation Hospital	Heidelberg	Victoria
Australia	Austin Health - Repatriation Hospital	Heidelberg West	Victoria
Australia	RK Will Pty Ltd	Victoria Park	Western Australia
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Brazil	Hospital das Clinicas Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	Clinica Medica Bonfliglioli Ltda.	Campinas	SP
Brazil	EDUMED - Educacao em Saude SS Ltda	Curitiba	PR
Brazil	CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor	Juiz De Fora	MG
Brazil	Hospital de Clinicas de Porto Alegre - UFRGS	Porto Alegre	RS
Brazil	CCBR Brasil - Centro de Pesquisas e Analises Clinicas LTDA	Rio de Janeiro	RJ
Brazil	Hospital Moinhos de Vento	Rio Grande De Sul
Brazil	SER - Servicos Especializados em Reumatologia da Bahia	Salvador	BA
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	São Jose do Rio Preto	SAO Paulo
Brazil	AACD- Lar Escola\ Associacao de Assistencia a Crianca Deficiente	Sao Paulo	SP
Brazil	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda	Sao Paulo
Brazil	CPCLin - Centro de Pesquisas Clinicas Ltda. / Clinica Dr. Freddy Goldberg Eliaschewitz LTDA EPP	Sao Paulo	SP
Brazil	Fundacao Faculdade de Medicina MECMPAS - Hospital das Clinicas da FMUSP	Sao Paulo	SP
Brazil	Hospital Israelita Albert Einstein	Sao Paulo	SP
Brazil	Instituto de Assistencia Medica do Hospital do Servidor Publico Estadual	Sao Paulo	SP
Brazil	CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo	Vitoria	Espírito Santo
Bulgaria	UMBAL "Dr Georgi Stranski" EAD	Pleven
Bulgaria	MBAL Eurohospital Plovdiv OOD	Plovdiv
Bulgaria	MBAL RUSe AD,	Ruse
Bulgaria	UMBAL Sveti Ivan Rilski" EAD	Sofia
Bulgaria	MBAL Sveta Marina EAD	Varna
Canada	Rheumatology Research Associates	Edmonton	Alberta
Canada	Medicine Professional Corporation	Ottawa	Ontario
Canada	Centre de Rhumatologie de l'Est du Quebec	Rimouski	Quebec
Canada	Centre de Recherche Musculo-Squelettique	Trois-Rivieres	Quebec
Canada	PerCuro Clinical Research Limited	Victoria	British Columbia
Canada	Clinical Research and Arthritis Centre	Windsor	Ontario
Chile	Centro de Investigacion Clinica Universidad Catolica (CICUC)	Santiago	Region Metropolitana
Chile	Prosalud	Santiago	Metropolitana
Chile	Centro Medico de Reumatologia Ltda.	Temuco	Region DE LA Araucania
China	Guangdong General Hospital	Guangzhou	Guangdong
Colombia	Centro de Investigaciones Clinica del Country	Bogota	Cundinamarca
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S	Bogota D.C.	Cundinamarca
Colombia	Servimed S.A.S	Bucaramanga	Santander
Colombia	Preventive Care S.A.S.	Chia	Cundinamarca
Colombia	Centro Integral de Reumatologia REUMALAB S.A.S.	Medellin	Antioquia
Czechia	REVMACLINIC s.r.o.	Brno
Czechia	Revmatologie, s.r.o.	Brno
Czechia	Revmacentrum MUDr. Mostera, s.r.o.	Brno - Zidenice
Czechia	Artroscan, s.r.o.	Ostrava
Czechia	Vesalion, s.r.o.	Ostrava	Czech Republic
Czechia	Mediscan Group, s.r.o.	Praha 11	Czech Republic
Czechia	Revmatologicky ustav.	Praha 2
Czechia	Revmatologicka Ambulance	Praha 4
Czechia	PV - MEDICAL s.r.o.	Zlin
Finland	Helsingin yliopistollinen keskussairaala	Helsinki
Finland	Kiljavan Laaketutkimus Oy	Hyvinkaa
Finland	Laakarikeskus Aava Hyvinkaan Pipetti	Hyvinkaa
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Chai Wan	HKG
Hong Kong	The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Shatin
Israel	Barzilai Medical Center - Rheumatology Outpatient Clinic	Ashkelon
Israel	Assaf Harofeh Medical Center	Beer Yaacov
Israel	Bnai Zion Medical Center Rheumatology Unit	Haifa
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center - Hebrew University Hospital	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Chaim Sheba Medical Center	Tel-Hashomer
Jordan	Istishari Hospital	Amman
Jordan	King Abdullah University Hospital	Irbid
Lebanon	Hotel Dieu de France Hospital	Achrafieh	Beirut
Lebanon	Ain Wazein Hospital	Lebanon
Malaysia	Hospital Selayang, Department of Medicine	Batu Caves	Selangor
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Mexico	Investigacion y Biomedicina de Chihuahua SC	Chihuahua
Mexico	CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.	Ciudad de Mexico
Mexico	Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C	Culiacan	Sinaloa
Mexico	Centro Integral en Reumatologia SA de CV	Guadalajara	Jalisco
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Unidad Reumatologica Las Americas S.C.P.	Merida	Yucatan
Mexico	Consultorio de Reumatologia	Mexico	Distrito Federal
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	Distrito Federal
Mexico	Centro de Investigacion Clinica de Morelia. S.C	Morelia	Michoacan
Mexico	Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC	Morelia	Michoacan
Mexico	Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.	San Luis Potosi
Mexico	Unidad de Investigaciones Reumatologicas	San Luis Potosi
Mexico	Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.	Torreon	Coahuila
Netherlands	Medical Center Leeuwarden	Leeuwarden
Netherlands	Universitair Medisch Centrum (UMC) Utrecht	Utrecht
New Zealand	Middlemore Hospital Middlemore Clinical Trials Trust	Auckland
New Zealand	Rheumatology Clinic, Waikato Hospital	Hamilton
New Zealand	Timaru Hospital	Timaru
New Zealand	Wellington Hospital	Wellington
Peru	Centro de lnvestigacion de la Red Asistencial del Hospital Nacional ESSALUD Carlos Alberto Seguin E.	Arequipa
Peru	ABK REUMA S.R.L. de Medicentro Biociencias- BIO CIENCIAS PERU S.R.L.	Lima
Peru	ACQ MEDIC S.A.C. - Centro de Investigacion Clinica Inmunoreumatologia	Lima
Peru	Centro de Investigacion de Reumatologia - Clinica San Borja	Lima
Peru	Centro de Investigacion en Salud - Centro de Excelencia en Reumatologia	Lima
Peru	Instituto Peruano del Hueso y la Articulacion - Instituto Peruano del Hueso y la Articulacion S.A.C.	Lima
Peru	Investigaciones Clinicas S.A.C.	Lima
Peru	Investigaciones en Reumatologia - Centro Medico Corpac	Lima
Peru	Unidad de Investigacion de la Clinica Internacional - Clinica Internacional	Lima
Peru	Centro de Investigacion Clinica Trujillo E.I.R.L. Clinica Peruana Americana	Trujillo	LA Libertad
Poland	Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska	Elblag
Poland	Centrum Medyczne Pratia Gdynia	Gdynia
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia
Poland	Centrum Medyczne Pratia Katowice	Katowice
Poland	Indywidualna Praktyka lekarska Dr hab. med. Anna Szczepanska - Szerej	Lublin
Poland	Zespol Poradni Specjalistycznych Reumed Filia Onyksowa	Lublin
Poland	NZOZ Lecznica MAK-MED	Nadarzyn	Mazowieckie
Poland	PROFMEDICUS Sp. z o.o., Osrodek Badan Klinicznych	Olsztyn
Poland	Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj	Poznan
Poland	Pomorskie Centrum Reumatologiczne im. Dr Jadwigi Titz-Kosko w Sopocie, Spolka. z o.o.	Sopot
Poland	KO-MED Centra Kliniczne Sp. zo.o.	Staszow
Poland	NASZ LEKARZ Przychodnie Medyczne	Torun
Poland	Rheuma Medicus Zaklad Opieki Zdrowotnej	Warsaw
Poland	Centrum Medyczne Pratia Warszawa	Warszawa
Poland	NZOZ Biogenes Sp. z o.o.	Wroclaw
Poland	Synexus Polska Sp. z o.o.	Wroclaw
Puerto Rico	Ponce Medical School Foundation, Inc.	Ponce
Puerto Rico	Fundacion de Investigaction de Diego	San Juan
Russian Federation	SBHI City Clinical Hospital #4 of HD of Moscow	Moscow
Russian Federation	SBHI of Moscow City Clinical Hospital 1 n. a. N.I. Pirogov of the Healthcare Department of Moscow	Moscow
Russian Federation	SBIH of Nizhniy Novgorod region City Clinical Hospital #5 of Nizhniy Novgorod district	Nizhniy Novgorod
Russian Federation	Consulting and Diagnostic Rheumatological Center Healthy Joints LLC	Novosibirsk
Russian Federation	Federal State Budgetary Scientific Institution "Research Institute of Fundamental and	Novosibirsk
Russian Federation	GBUZ RK Republic Hospital n. a. V.A. Baranov of the MoH & social development Of The Karelia Republic	Petrozavodsk
Russian Federation	Federal State Budgetary Educational Institution of Higher Education	Smolensk
Russian Federation	Saint-Petersburg State Budget Healthcare Institution Consultative-diagnostic Center #85	St. Petersburg
Russian Federation	Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the	St. Petersburg	St.petersburg
Russian Federation	Municipal Budgetary Institution "Central City Clinical Hospital #6"	Yekaterinburg
Russian Federation	SBEI of HPE Ural State Medical University of the MoH of the RF	Yekaterinburg
Slovakia	Nestatna reumatologicka ambulancia	Bratislava
Slovakia	ROMJAN s.r. o. , Specializovana Reumatologicka ambulancia	Bratislava - Petrzalka
Slovakia	AAGS, s.r.o., Reumatologicka ambulancia	Dunajska Streda
Slovakia	ECCLESIA s.r.o, Reumatologicka ambulancia	Nove Zamky
Slovakia	REUMACENTRUM s.r.o., Reumatologicka ambulancia	Partizanske
Slovakia	Reumex s.r.o	Rimavska Sobota
Slovakia	Reuma-Global s.r.o., Reumatologicka ambulancia	Trnava
South Africa	Tiervlei Trial Centre, Karl Bremer Hospital	Bellville, Cape Town	Western CAPE
South Africa	Arthritis Clinical Research Trials cc	Cape Town	Western CAPE
South Africa	Panorama Medical Centre	Cape Town	Western CAPE
South Africa	University of Cape Town	Cape Town	Western CAPE
South Africa	St. Augustine's Hospital - Chelmsford Medical Centre 2	Durban	Kwa-zulu Natal
South Africa	Wits Clinical Research Site	Johannesburg	Gauteng
South Africa	Clinresco Centres ( Pty ) Ltd	Kempton Park	Gauteng
South Africa	Greenacres Hospital	Port Elizabeth	Eastern CAPE
South Africa	Emmed Research	Pretoria	Gauteng
South Africa	Jakaranda Hospital	Pretoria	Gauteng
South Africa	Winelands Medical Research Centre-	Stellenbosch
Spain	Hospital Universitario de Cruces	Barakaldo	Vizcaya
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Plato	Barcelona
Spain	Hospital Universitario de Basurto	Bilbao	Vizcaya
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Regional Universitario de Malaga	Malaga
Spain	Hospital de Merida	Merida	Badajoz
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Nuestra Senora de la Esperanza	Santiago de Compostela	LA Coruna
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Buddhist Dalin Tzu Chi General Hospital	Chia-Yi
Taiwan	China Medical University Hospital	Taichung City	Taiwan (r.o.c)
Taiwan	Chung Shan Medical University Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou Branch	Taoyuan City
Thailand	Faculty of Medicine , Siriraj Hospital , Mahidol University	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok
Thailand	Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,Chiang Mai University	Chiang Mai
Thailand	Prince of Songkla University	Songkhla
Turkey	Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Adnan Menderes Universitesi Tip Fakultesi Hastanesi	Aydin
Turkey	Gaziantep Universitesi Tip Fakultesi	Gaziantep
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Izmir Tepecik Egitim ve Arastirma Hastanesi	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi Fiziksel Tip ve	Samsun
Turkey	Cumhuriyet Universitesi Tip Fakultesi Hastanesi	Sivas
United Kingdom	The Royal Wolverhampton NHS Trust-Cannock Chase Hospital	Cannock
United Kingdom	Barking, Havering and Redbridge University Hospitals NHS Trust	Goodmayes	Essex
United Kingdom	Aintree University Hospital, Liverpool University Hospitals	Liverpool
United Kingdom	Clinical trials, Pharmacy Department, Aintree University Hospitals	Liverpool
United Kingdom	University of Liverpool Academic Rheumatology Unit. Aintree University Hospital. Liverpool Universit	Liverpool
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Clinical Research Facility	Newcastle Upon Tyne
United Kingdom	Northumbria Healthcare NHS Foundation Trust	North Shields
United Kingdom	Poole Hospital, University Hospitals Dorset NHS Foundation Trust	Poole	Dorset
United Kingdom	Pharmacy Department	Wolverhampton
United States	Amarillo Center for Clinical Research, Ltd.	Amarillo	Texas
United States	Arthritis and Rheumatology of GA, P.C.	Atlanta	Georgia
United States	Austin Regional Clinic	Austin	Texas
United States	Bronson Healthcare Group	Battle Creek	Michigan
United States	University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program	Birmingham	Alabama
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	RASF-Clinical Research Center, Inc	Boca Raton	Florida
United States	Bay Area Arthritis and Osteoporosis	Brandon	Florida
United States	Weill Cornell Physicians at Brooklyn Heights	Brooklyn	New York
United States	Medical Associates of North Georgia - Rheumatology	Canton	Georgia
United States	Trinity Universal Research Associates, Inc	Carrollton	Texas
United States	Rheumatology Associates, P.A.	Charleston	South Carolina
United States	Center for Arthritis and Rheumatic Diseases, PC	Chesapeake	Virginia
United States	Cincinnati Rheumatic Disease Study Group, Inc.	Cincinnati	Ohio
United States	Arthritis & Rheumatism Associates (Private Practice)	Clearwater	Florida
United States	Dr.Robert W. Levin MDOffice of	Clearwater	Florida
United States	Florida Clinical Research Group (Administrative Office)	Clearwater	Florida
United States	Summit Medical Group	Clifton	New Jersey
United States	Coeur D'Alene Arthritis Clinic	Coeur d'Alene	Idaho
United States	Arthritis Associates and Osteoporosis Center of Colorado Springs	Colorado Springs	Colorado
United States	Medvin Clinical Research	Covina	California
United States	Klein & Associates, M.D.,P.A.	Cumberland	Maryland
United States	Pioneer Research Solutions, Inc.	Cypress	Texas
United States	Arthritis Centers of Texas	Dallas	Texas
United States	Baylor Scott and White Research Institute / Arthritis Care and Research Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	STAT Research, Inc.	Dayton	Ohio
United States	International Medical Research	Daytona Beach	Florida
United States	Office of Jefrey D. Lieberman, MD, PC	Decatur	Georgia
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	EmergeOrtho,P.A.	Durham	North Carolina
United States	St. Paul Rheumatology, PA	Eagan	Minnesota
United States	Med Investigations, Inc.	Fair Oaks	California
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	Arthritis Treatment Center	Frederick	Maryland
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Northwell Health Division of Rheumatology	Great Neck	New York
United States	Innovative Clinical Research, LLC	Greenville	South Carolina
United States	Physicians East, PA	Greenville	North Carolina
United States	Piedmont Arthritis Clinic, PA	Greenville	South Carolina
United States	Klein & Associates, MD, PA	Hagerstown	Maryland
United States	Frycare outpatient imaging Center	Hickory	North Carolina
United States	PMG Research of Hickory LLC	Hickory	North Carolina
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	CHI St. Vincent Medical Group Hot Springs	Hot Springs	Arkansas
United States	Accurate Clinical Management, LLC	Houston	Texas
United States	Accurate Clinical Management, LLC	Houston	Texas
United States	Accurate Clinical Research, Inc.	Houston	Texas
United States	Houston Institute for Clinical Research	Houston	Texas
United States	Medical Center Research, LLC	Houston	Texas
United States	Rheumatic Disease Clinical Research Center	Houston	Texas
United States	Talbert Medical Group	Huntington Beach	California
United States	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama
United States	Diagnostic Rheumatology and Research PC	Indianapolis	Indiana
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	University of Florida - Rheumatology at ACC	Jacksonville	Florida
United States	University of Florida College of Medicine, Jacksonville - Rheumatology Research	Jacksonville	Florida
United States	Arthritis And Rheumatism Associates LLC	Jonesboro	Arkansas
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Bronson Rheumatology Specialists	Kalamazoo	Michigan
United States	Jasper Clinic, Inc.	Kalamazoo	Michigan
United States	Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research	Kalamazoo	Michigan
United States	Glacier View Research Institute	Kalispell	Montana
United States	Kansas City Internal Medicine	Kansas City	Missouri
United States	Rheumatology Consultants, PLLC	Knoxville	Tennessee
United States	University of California, San Diego (UCSD)- Perlman Ambulatory Clinic	La Jolla	California
United States	NYU Langone Rheumatology Associates Long Island.	Lake Success	New York
United States	June DO,PC	Lansing	Michigan
United States	EKSAKTI, LLC (dba: Eksakti Clinical Research)	Las Vegas	Nevada
United States	Steinberg Diagnostics	Las Vegas	Nevada
United States	University of Nevada School of Medicine	Las Vegas	Nevada
United States	Accurate Clinical Research, Inc.	League City	Texas
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	ProHealth Partners	Long Beach	California
United States	Valerius Medical Group And Research Center Of Greater Long Beach, Inc.	Long Beach	California
United States	Keck Medicine of USC	Los Angeles	California
United States	Arthritis and Osteoporosis Associates, LLP	Lubbock	Texas
United States	Dr. Ramesh C. Gupta MD, Office of	Memphis	Tennessee
United States	Center for Diagnostic Imaging	Mendota Heights	Minnesota
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	Center for Arthritis and Rheumatic Diseases	Miami	Florida
United States	Doctors Research Institute	Miami	Florida
United States	San Marcus Research Clinic	Miami Lakes	Florida
United States	Trinity Health Center - Medical Arts	Minot	North Dakota
United States	Arthritis and Diabetes Clinic, Inc.	Monroe	Louisiana
United States	Nashua Rheumatology	Nashua	New Hampshire
United States	Center For Inflammatory Disease	Nashville	Tennessee
United States	California Medical Research Associates Inc	Northridge	California
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Advanced Clinical Research of Orlando	Ocoee	Florida
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma Medical Research Foundation (OMRF)	Oklahoma City	Oklahoma
United States	Westroads Clinical Research, Inc.	Omaha	Nebraska
United States	Arthritis & osteoporosis treatment center,PA	Orange Park	Florida
United States	Articluaris Healthcare Group d/b/a ACME Research	Orangeburg	South Carolina
United States	Omega Research Consultants, LLC	Orlando	Florida
United States	Rheumatology Associates of Central Florida, PA	Orlando	Florida
United States	Millennium Research	Ormond Beach	Florida
United States	MidWest Clinical Research, LLC	Overland Park	Kansas
United States	Desert Medical Advances	Palm Desert	California
United States	Arthritis Center, Inc.	Palm Harbor	Florida
United States	Arthritis Research of Florida, Inc.	Palm Harbor	Florida
United States	The Arthritis Group	Philadelphia	Pennsylvania
United States	UPMC Arthritis and Autoimmunity Clinic	Pittsburgh	Pennsylvania
United States	UPMC Lupus Center of Excellence	Pittsburgh	Pennsylvania
United States	Medvin Clinical Research	Placentia	California
United States	Trinity Universal Research Associates, Inc.	Plano	Texas
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Advanced Urgent Care	Port Orange	Florida
United States	Quincy Medical Group	Quincy	Illinois
United States	Arthritis Center Of Reno	Reno	Nevada
United States	Mayo Clinic	Rochester	Minnesota
United States	Sierra Rheumatology, Inc.	Roseville	California
United States	Shores Rheumatology P.C.	Saint Clair Shores	Michigan
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Dr. Orrin M. Troum, Md And Medical Associates	Santa Monica	California
United States	Clinvest Research, LLC	Springfield	Missouri
United States	Springfield Clinic	Springfield	Illinois
United States	PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare	Statesville	North Carolina
United States	Center for Arthritis and Rheumatic Diseases, P.C.	Suffolk	Virginia
United States	Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology	Summerville	South Carolina
United States	USF Health Morsani Center for Advanced Healthcare	Tampa	Florida
United States	Harbor UCLA Medical Center	Torrance	California
United States	Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center	Torrance	California
United States	Southern Arizona VA Health Care System (SAVAHCS)	Tucson	Arizona
United States	University of Arizona Clinical and Translational Science Research Center	Tucson	Arizona
United States	Clinical and Translational Research Center of Alabama, PC	Tuscaloosa	Alabama
United States	Robin K. Dore M.D., Inc.	Tustin	California
United States	Medvin Clinical Research	Van Nuys	California
United States	Ventura Clinical Trials	Ventura	California
United States	Desert Valley Medical Group	Victorville	California
United States	Howard University Hospital	Washington	District of Columbia
United States	The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC	Wheaton	Maryland
United States	Medvin Clinical Research	Whittier	California
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Carolina Arthritis Associates	Wilmington	North Carolina
United States	UMass Memorial Medical Center, Memorial Campus	Worcester	Massachusetts
United States	Clinical Research Center of Reading, LLC	Wyomissing	Pennsylvania
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Finland,  Hong Kong,  Israel,  Jordan,  Lebanon,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Peru,  Poland,  Puerto Rico,  Russian Federation,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to last contact date (maximum up to 72 months)
Primary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	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)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	Baseline up to last contact date (maximum up to 72 months)
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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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