Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413699
• Other study ID #: A3921024
• Secondary ID: 2006-005035-19
• Status: Completed
• Phase: Phase 3
• Start date: February 5, 2007
• Est. completion date: October 26, 2017

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4488
• Est. completion date: October 26, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Vaccine sub-study visit

• Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

Exclusion Criteria:

• Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Vaccine sub-study visit

1. Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study

2. Received any vaccine within 1 month prior to randomization in this study

3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• CP-690,550
5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
• CP-690,550
10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Reumatologicas y Osteologicas -CIRO	Buenos Aires	Caba
Argentina	Consultorios Reumatologicos Pampa	Buenos Aires
Argentina	Hospital Sirio Libanes	Buenos Aires
Argentina	Hospital Sirio Libanes	Buenos Aires
Argentina	OMI - Organización Médica de Investigación	Buenos Aires
Argentina	OMI- Organizacion Medica de Investigacion	Buenos Aires	Caba
Argentina	Saint Dennis Medical Group S.A.	Buenos Aires
Australia	Rheumatology Research	Cairns	Queensland
Australia	Optimus Clinical Research Pty. Ltd.	Kogarah	New South Wales
Australia	Emeritus Research	Malvern East	Victoria
Australia	Rheumatology Research Unit Sunshine Coast	Maroochydore	Queensland
Australia	Goatcher Clinical Research Unit	Perth	Western Australia
Australia	Royal North Shore Hospital	St Leonards
Australia	Queen Elizabeth Hospital, Department of Rheumatology	Woodville	South Australia
Austria	Medizinische Universitaet Wien / AKH	Wien
Austria	Rheuma-Ordination Favoriten	Wien
Austria	Sozialmedizinisches Zentrum Sued - Kaiser Franz Josef Spital	Wien
Belgium	Universitair Ziekenhuis Gent - Reumatologie	Gent	Oost-vlaanderen
Belgium	AZ Groeninge	Kortrijk
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Bosnia and Herzegovina	University Clinical Center Sarajevo	Sarajevo
Brazil	Centro de Estudos em Terapias Inovadoras	Curitiba	Paraná
Brazil	Centro de Estudos em Terapias Inovadoras	Curitiba	PR
Brazil	CIP - Centro Internacional de Pesquisa	Goiania	GO
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda	Rio de Janeiro	RJ
Brazil	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda	Sao Paulo
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo	SP
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)	Sao Paulo	SP
Brazil	IMA Brasil -Instituto de Pesquisa Clinica e Medicina Avancada	Sao Paulo	SP
Bulgaria	Revmatologichen kabinet, DKTs Sveti Pantaleimon OOD	Pleven
Bulgaria	Revmatologichno Otdelenie, MBAL - Plovdiv	Plovdiv
Bulgaria	UMBAL Kaspela Plovdiv	Plovdiv
Bulgaria	MBAL Akta Medika OOD	Sevlievo
Bulgaria	Clinic of Cardiology and Rheumatology Military Medical Academy	Sofia
Bulgaria	Clinic of Rheumatology Multiprofile Hospital for Active treatment Sveti Ivan Rilski	Sofia
Bulgaria	DKTs "Sveta Anna" Sofia, Konsultativen kabinet po Revmatologia	Sofia
Bulgaria	DKTs "Sveta Anna", Sofia / Diagnostic Consultative Center "Sveta Anna"	Sofia
Bulgaria	MBAL Sveti Ivan Rilski Sofia	Sofia
Bulgaria	MOBAL "D-r Stefan Cherkezov" AD,	Veliko Tarnovo
Canada	Rheumatology Research Associates Ltd.	Edmonton	Alberta
Canada	Cividino Medicine Professional Corporation	Hamilton	Ontario
Canada	Dr. William G. Bensen Medicine Professional Corporation	Hamilton	Ontario
Canada	Office of Dr. Fernando Bianchi	Hamilton	Ontario
Canada	KW Musculoskeletal Research Inc.	Kitchener	Ontario
Canada	St Joseph's Health Centre	London	Ontario
Canada	Credit Valley Rheumatology	Missisauga	Ontario
Canada	Institut de Rhumatologie de Montreal	Montreal	Quebec
Canada	The Arthritis Program Research Group Inc.	Newmarket	Ontario
Canada	Rheumatology and Osteoporosis Clinic	Oakville	Ontario
Canada	Rheumatology Research Associates	Ottawa	Ontario
Canada	West Island Rheumatology Research Associates	Pointe Claire	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.	Quebec
Canada	Arthritis Research Center, Royal University Hospital	Saskatoon	Saskatchewan
Canada	Niagara Peninsula Arthritis Centre	St. Catharines	Ontario
Canada	Nexus Clinical Research	St. John's	Newfoundland and Labrador
Canada	Centre de Recherche Musculo-Squelettique	Trois-Rivieres	Quebec
Canada	Dr. Alice Klinkhoff, Inc.	Vancouver	British Columbia
Canada	Percuro Clinical Research Limited	Victoria	British Columbia
Canada	Clinical Research and Arthritis Centre	Windsor	Ontario
Canada	Manitoba Clinic	Winnipeg	Manitoba
Chile	Clinica Santa Maria, Seccion Reumatologia	Providencia	Santiago, RM
Chile	Hospital Regional de Rancagua	Rancagua
Chile	Centro de Diagnostico y Tratamiento Hospital San Borja Arriaran	Santiago	Region Metropolitana
Chile	Centro de Estudios Reumatologicos	Santiago	RM
Chile	Clinica Santa Maria	Santiago
Chile	Consulta Privada Dra. Marta Aliste	Santiago	RM
Chile	Consulta Privada Dra. Lucia Ponce	Temuco	IX Region
Chile	Hospital Base Valdivia, Policlinico de Reumatologia	Valdivia	Region XIV
Chile	Estudios Clinicos V Region	Vina Del Mar, V Region
China	Beijing Chaoyang Hospital, Capital University of Medical Science	Beijing	Beijing
China	Peking University People's Hospital/Rheumatology and Immunology Department	Beijing
China	PLA General Hospital	Beijing
China	Xiangya Hospital of Centre-south University	Changsha	Hunan
China	Si Chuan Huaxi Hospital	Chengdu
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	An Hui Medical University 1st Hospital	Hefei
China	Anhui Province Hospital	Hefei
China	QiLu Hospital of Shandong University	Jinan	Shandong
China	Jiangsu Province Hospital	Nanjing
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shanghai Changhai Hospital	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou
China	"Department of Infectious Diseases & Immunology	Tianjin
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Xijing Hospital, The Fourth Military Medical University	Xi'an	Shaanxi
Colombia	Centro de Reumatologia y Ortopedia S.A.S.	Barranquilla	Atlantico
Colombia	Riesgo de Fractura S.A.	Bogota D.C.	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
Costa Rica	Centro de Reumatologia y Osteoporosis, Cartago	Cartago
Costa Rica	Hospital Cima San Jose	San Jose
Costa Rica	Hospital Cima San Jose	San Jose
Costa Rica	Oficina Privada Del Colegio deMedicos	San Jose
Croatia	University Hospital Center Osijek	Osijek
Croatia	University Hospital Split, Department for Internal Medicine, Division of Clinical Rheumatology	Split
Croatia	Clinical Hospital "Sveti Duh"	Zagreb
Croatia	University Hospital Center "Zagreb"	Zagreb
Croatia	University Hospital Center Zagreb	Zagreb
Czechia	Fakultni Nemocnice Brno, Interni hematoonkologicka klinika	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Revmacentrum MUDr. Mostera, s.r.o.	Brno
Czechia	X-MEDICA s.r.o.	Brno
Czechia	HESTE s.r.o. Revmatologie	Ceska Lipa
Czechia	MEDIPONT Plus sro	Ceske Budejovice
Czechia	L.K.N. Arthrocentrum, s.r.o.	Hlucin
Czechia	ARTMEDI UPD s r.o	Hostivice
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Revmatologicka ambulance	Ostrava
Czechia	ARTHROMED, s. r. o. Revmatologicka ambulance	Pardubice
Czechia	Affidea Praha, s.r.o.	Praha 11 - Chodov
Czechia	Revmatologicky ustav	Praha 2
Czechia	Fakultni Thomayerova nemocnice s poliklinikou	Praha 4
Czechia	Nuselska poliklinika RTG	Praha 4
Czechia	Revmatologicka ambulance	Praha 4
Czechia	Revmatologicka ambulance	Praha 4
Czechia	Nemocnice Atlas, a.s.	Zlin
Czechia	PV-Medical s.r.o.	Zlin
Denmark	Frederiksberg Hospital	Frederiksberg
Dominican Republic	Hospital Central de las Fuerzas Armadas	Santo Domingo
Finland	Helsingin Reumakeskus Oy	Helsinki
Finland	Kiljavan Laaketutkimus Oy	Hyvinkaa
Finland	TAYS/Reumakeskus/Finn-Medi 1	Tampere
France	Hopital Nord	Amiens
France	Hôpital Nord	Amiens
France	*CHR Hopital Porte Madeleine IPROS	Orleans
France	CHR ORLEANS - Service IPROS	Orleans
France	Hopital Cochin	Paris
France	Hôpital Saint-Antoine	Paris
Germany	Privat-Praxis	Aachen
Germany	Ambulantes Rheumazentrum Dr Soerensen	Berlin
Germany	Charite Campus Mitte, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie	Berlin
Germany	Schlosspark-Klinik Innere Medizin II, Rheumatologie	Berlin
Germany	Krankenhaus Friedrichstadt, I. Medizinische Klinik	Dresden
Germany	Studienambulanz Universitaetsklinikum Erlangen Medizinische Klinik 3	Erlangen
Germany	J.W.-Goethe-Universitaetsklinik, Medizinische Klinik II, Abteilung fuer Rheumatologie	Frankfurt am Main
Germany	Schwerpunktpraxis Rheumatologie	Halle
Germany	Schoen Klinik Hamburg-Eilbek	Hamburg
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Universitaetsklinikum Koeln Klinik I fuer Innere Medizin, Haus 16, 1. OG, Raum 1.008	Koeln
Germany	Universitaetsklinik Leipzig, Klinik fur Gastroenterologie und Rheumatologie, Sektion Rheumatologie	Leipzig
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Klinikum der Universitaet Muenchen, Campus Innenstadt, Rheuma-Einheit	Muenchen
Germany	Arztpraxis, Internist - Rheumatologie	Nuernberg
Germany	Rheumaforschung- Studienambulanz	Ratingen
Germany	Schwerpunktpraxis fuer Rheumatologie	Rheine
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Greece	424 General Army Hospital	Thessaloniki
Greece	General Hospital Euromedica "KYANOUS STAVROS"	Thessaloniki
Hungary	Drug Research Center Kft	Balatonfured
Hungary	Orszagos Reumatologiai Es Fizioterapias Intezet	Budapest
Hungary	Revita Reumatologiai Rendelo	Budapest
Hungary	Synexus Magyarorszag Kft.	Budapest
Hungary	MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles	Szolnok
India	Rheumatic Diseases Clinic	Ahmedabad	Gujarat
India	Shalby Hospitals	Ahmedabad	Gujarat
India	Chanre Rheumatology & Immunology Center & Research	Bangalore	Karnataka
India	Chanre Rheumatology and Immunology Center and Research	Bangalore	Karnataka
India	Shirdi Sai Hospital	Bangalore	Karnataka
India	St. John's Medical College and Hospital.	Bangalore	Karnataka
India	Mahavir Hospital & Research Center	Hyderabad	Andhra Pradesh
India	Arthritis Research and Care Foundation Centre for Rheumatic Diseases	Pune	Maharashtra
India	Jehangir Clinical Development Centre Pvt. Ltd.	Pune	Maharashtra
India	Krishna Institute of Medical Sciences Ltd	Secunderabad	Telangana
Ireland	St. Vincent's University Hospital	Elm Park	Dublin
Italy	A.O.U. Careggi - SOD Medicina Interna 1 e Reumatologia	Firenze	FI
Italy	U.O. Clinica Reumatologica	Genova
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Eulji University Hospital	Daejeon	Republic OF Korea
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Jung-gu	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center-University of Ulsan College of Medicine	Seoul
Korea, Republic of	Gangnam Severance Hospital-Yonsei University Health System	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital-The Catholic University of Korea	Seoul
Korea, Republic of	Yonsei University Health System	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul,
Malaysia	Hospital Selayang	Batu Caves	Selangor
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu	Sabah
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Malaysia	Sunway Medical Centre	Petaling Jaya	Selangor
Malaysia	Hospital Putrajaya, Dept. of Medicine	Putrajaya	Wilayah Persekutuan
Malaysia	Hospital Tuanku Ja'afar	Seremban	Negeri Sembilan
Malaysia	Subang Jaya Medical Centre	Subang Jaya	Selangor
Mexico	Investigacion y Biomedica de Chihuahua, SC	Chihuahua
Mexico	Centro de Investigacion Clinica Especializada, SC	Coyoacan	Mexico D.F.
Mexico	Fundacion El Hospitalito	Cuernavaca	Morelos
Mexico	Centro Integral en Reumatologia, SA de CV	Guadalajara	Jalisco
Mexico	Unidad de Investigacion en Enfermedades Cronico Degenerativas	Guadalajara	Jalisco
Mexico	Unidad Reumatologica Las Americas SCP	Merida	Yucatan
Mexico	Centro Medico Toluca	Metepec	Estado DE Mexico
Mexico	Hospital Angeles del Pedregal	Mexico	DF
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City
Mexico	Hospital Angeles Mocel	Mexico, D.F.
Mexico	Hospital Universitario Doctor Jose Eleuterio Gonzalez	Monterrey	Nuevo LEON
Mexico	Centro de Investigacion Clinica de Morelia	Morelia	Michoacan
Mexico	Clinica de Enfermedades Cronicas y Procedimientos Especiales SC	Morelia	Michoacan
Mexico	Centro Reumatologico Queretaro	Queretaro
Mexico	Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.	San Luis Potosi
Mexico	Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Reumatologia y Osteoporosis	San Luis Potosi
Mexico	Centro de Investigacion del Noroeste	Tijuana	BAJA California Norte
Mexico	Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC	Torreon	Coahuila
New Zealand	The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital	Christchurch
New Zealand	Waikato Hospital, Rheumatology	Hamilton
New Zealand	Clinical Trials Unit, Timaru Hospital	Timaru
Peru	Hospital Nacional IV Alberto Sabogal Sologuren	Callao
Peru	Centro Medico Corpac/Investigaciones en Reumatologia	Lima
Peru	Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR	Lima
Philippines	Angeles University Foundation Medical Center	Angeles City	Pampanga
Philippines	Chong Hua Hospital	Cebu City
Philippines	De La Salle University Health Sciences Campus Clinical Epidemiology Unit	Dasmarinas	Cavite
Philippines	Southern Philippine Medical Center	Davao City
Philippines	University of Perpetual Help Rizal Dalta Medical Center	Las Piñas City
Philippines	Mary Mediatrix Medical Center	Lipa City	Batangas
Philippines	University of Santo Tomas Hospital	Manila
Poland	"ZDROWIE OSTEO-MEDIC" s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik	Bialystok
Poland	ClinicMed Badurski i wspolnicy Spolka Jawna	Bialystok
Poland	NSZOZ Medicus II	Cieszyn
Poland	Szpital im. Teodora Dunina	Koscian
Poland	Krakowskie Centrum Medyczne NZOZ	Krakow
Poland	Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski	Poznan
Poland	Wojewodzki Zespol Reumatologiczny im. dr Jadwigi Titz-Kosko	Sopot
Poland	Nzoz "Nasz Lekarz"	Torun
Poland	Rheuma-Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	SYNEXUS Polska Sp. z.o.o.	Wroclaw
Puerto Rico	Edificio Parra	Ponce
Puerto Rico	Ponce School Of Medicine	Ponce
Puerto Rico	Mindful Medical Research	San Juan
Romania	Spitalul Clinic "Sf. Maria"	Bucharest
Romania	Spitalul Clinic De Recuperare	Iasi
Russian Federation	State Healthcare Institution Regional Clinical Hospital	Barnaul
Russian Federation	Ltd.Medical Association "Novaya Bolnitsa"	Ekaterinburg
Russian Federation	State Educational Institution of Higher Professional Education	Ekaterinburg
Russian Federation	State Educational Institution of Higher Professional Education Ural State Medical Academy of Federal	Ekaterinburg
Russian Federation	State Healthcare Institution	Ekaterinburg
Russian Federation	State Healthcare Institution Regional Clinical Hospital for War Veterans	Kemerovo
Russian Federation	Rheumatology Research Institute of Russian Academy of Medical Sciences	Moscow
Russian Federation	Russian State Medical University Moscow Faculty City Clinical Hospital #4	Moscow
Russian Federation	"Consultative Diagnostic Rheumatology Center ""Healthy Joints"", LLC"	Novosibirsk City	Novosibirsk Region
Russian Federation	City Clinical Hospital # 1	Novosibirsk City	Novosibirsk Region
Russian Federation	GUZ Republican Hospital n.a. Baranov	Petrozavodsk
Russian Federation	Federal North-West Medical Research Centre	Saint-Petersburg
Russian Federation	State Healthcare Institution City Hospital # 40 of Administrative Health Resort District	Saint-Petersburg	Sestroretsk, Russia
Russian Federation	Smolensk State Medical Academy	Smolensk	Smolensk Region
Russian Federation	Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency	St. Petersburg
Russian Federation	St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85	St. Petersburg
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution "Clinical Rheumathology Hospital #25"	St. Petersburg,
Russian Federation	Regional State Budget Institution Of Healthcare	Tomsk
Russian Federation	Regional State Budgetary Healthcare Institution of Tomsk Regional Clinical Hospital	Tomsk
Slovakia	NOVAPHARM s.r.o -Zeleznicna NaP, Reumatologicka ambulancia	Bratislava
Slovakia	Reumatologicka ambulancia, Poliklinika Ruzinov	Bratislava
Slovakia	AAGS, s.r.o. , nestatne zdravotnicke zariadenie	Dunajska Streda
Slovakia	Interna a reumatologicka ambulancia	Kosice
Slovakia	Ecclesia, s.r.o Reumatologicka ambulancia	Nove Zamky
Slovakia	Narodny Ustav Reumatickych Chorob	Piestany
Slovakia	Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.	Poprad
Slovakia	Reumatologicka ambulancia, REUMEX, s.r.o.	Rimavska Sobota
Slovakia	Reumatologicka ambulancia, Nestatne zdravotnicke zariadenie	Senica
Slovakia	Nestatna reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.	Zilina
Spain	Hospital Universitario Cruces	Barakaldo	Vizcaya
Spain	Hospital Del Mar	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Complejo Hospitalario Universitario A Coruna	Coruna
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario De La Paz	Madrid
Spain	Hospital Civil. Hospital Regional Universitario Carlos Haya	Malaga
Spain	Hospital de Merida	Merida	Badajoz
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	A Coruna
Spain	Hospital Nuestra Senora de la Esperanza	Santiago De Compostela	A Coruna
Spain	Hospital El Tomillar	Sevilla
Spain	Hospital Nuestra Señora de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Sweden	Falu lasarett	Falun
Sweden	Lanssjukhuset Ryhov	Jonkoping
Sweden	Skanes Universitetssjukhus i Malmo Reumamottagningen	Malmo
Sweden	Sundsvalls Sjukhus	Sundsvall
Sweden	Norrlands Universitetssjukhus	Umea
Sweden	Akademiska University Hospital	Uppsala
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Kwei-Shan	Taoyuan County
Taiwan	Chang Gung Medical Foundation-	Niao Sung Hsiang	Kaohsiung County
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,	Amphoe Mueang	Chiang MAI
Thailand	Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok
Thailand	Division of Allergy-Immunology-Rheumatology, Department of Medicine, Faculty of Medicine	Muang District	Khonkaen
Thailand	Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital	Rajathevee	Bangkok
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Ege University Medical Faculty	Bornova	Izmir
Turkey	Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi	Izmir
Ukraine	Municipal Establishment of Health Care "Kharkiv City Clinical Hospital #8", Dept. of Rheumatology	Kharkiv
Ukraine	State Establishment "Institute of Gerontology of NAMS of Ukraine n.a. D.F. Chebotareva"	Kyiv
Ukraine	State Institution Republican Clinical Hospital of the Ministry of Health of Ukraine	Kyiv
Ukraine	Municipal City Clinical Hospital #4, Policlinic Care	Lviv
Ukraine	"Multifield Medical Center of Odesa National Medical University ""University Clinic #1"""	Odesa
Ukraine	Multifield Medical Center of Odesa National Medical University "University Clinic #1"	Odesa
Ukraine	Crimean Republican Institution "Clinical Territorial Medical Association "University Clinic",	Simferopol	Crimea
Ukraine	CRIMEAN Republican Institution, "Clinical Hospital n.a. M.O. Semashko"	Simferopol Crimea
Ukraine	Vinnitsa Regional Clinical Hospital n.a. Pirogov	Vinnitsa
Ukraine	Municipal Establishment "City Hospital#7of Zaporizhzhia State Medical University	Zaporizhzhia
United Kingdom	The Royal Wolverhampton NHS Trust	Cannock
United Kingdom	Dudley Group of Hospitals NHS Trust	Dudley	WEST Midlands
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Wirral University Teaching Hospital NHS Foundation Trust-Arrowe Park Hospital	Wirral
United States	The Center for Rheumatology, LLP	Albany	New York
United States	Office of John P. Lavery, MD, PA	Allen	Texas
United States	Asheville Rheumatology & Osteoporosis Research Associates, P.A.	Asheville	North Carolina
United States	Asheville Rheumatology & Osteoporosis Research Associates, PA	Asheville	North Carolina
United States	Arthritis and Rheumatology of Georgia P.C.	Atlanta	Georgia
United States	Austin Rheumatology Research, PA	Austin	Texas
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Ochsner Clinic Foundation - Baton Rouge	Baton Rouge	Louisiana
United States	Bronson Internal Medicine and Rheumatology	Battle Creek	Michigan
United States	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania
United States	QUEST Research Institiute	Bingham Farms	Michigan
United States	Regional Rheumatology Associates	Binghamton	New York
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	St. Luke's Clinic	Boise	Idaho
United States	St. Luke's Clinic - Rheumatology	Boise	Idaho
United States	St. Luke's Intermountain Research Center	Boise	Idaho
United States	Boulder Medical Center, PC	Boulder	Colorado
United States	Physician's Clinic of Iowa, P.C.	Cedar Rapids	Iowa
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Cincinnati Rheumatic Disease Study Group, Inc.	Cincinnati	Ohio
United States	Mountain State Clinical Research	Clarksburg	West Virginia
United States	Arthritis Associates and Osteoporosis Center of Colorado Springs	Colorado Springs	Colorado
United States	University Of Missouri-Columbia	Columbia	Missouri
United States	University Physicians - Woodrail Clinic	Columbia	Missouri
United States	Klein and Associates, MD, PA	Cumberland	Maryland
United States	Arthritis Care and Diagnostic Center, P.A.	Dallas	Texas
United States	Baylor Research Institute	Dallas	Texas
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	STAT Research, Inc.	Dayton	Ohio
United States	Allergy, Asthma, Arthritis, & Lung	Daytona Beach	Florida
United States	Physicians Research Alliance LLC	DeBary	Florida
United States	Jeffrey D. Lieberman, MD, PC	Decatur	Georgia
United States	Medical Associates Clinic, PC	Dubuque	Iowa
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Arthritis and Rheumatology Consultants, P.A.	Edina	Minnesota
United States	Med Investigations, Inc.	Fair Oaks	California
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of North Texas Health Science Center at Fort Worth	Fort Worth	Texas
United States	The Arthritis Treatment Center	Frederick	Maryland
United States	Southeastern Arthritis Center	Gainesville	Florida
United States	Southeastern Imaging and Diagnostics	Gainesville	Florida
United States	Southeastern Integrated Medical PL d/b/a Florida Medical Research Institute	Gainesville	Florida
United States	Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute	Gainesville	Florida
United States	Arthrocare, Arthritis Care & Research, PC	Gilbert	Arizona
United States	Piedmont Arthritis Clinic, PA	Greenville	South Carolina
United States	Arthritis & Osteoporosis Center, PC	Hamden	Connecticut
United States	PMG Research Hickory, LLC	Hickory	North Carolina
United States	PMG Research of Hickory	Hickory	North Carolina
United States	Arthritis Associates, PLLC	Hixson	Tennessee
United States	CHI St. Vincent Medical Group Hot Springs	Hot Springs	Arkansas
United States	Accurate Clinical Research, Inc.	Houston	Texas
United States	Houston Institute for Clinical Research	Houston	Texas
United States	Talbert Medical Group	Huntington Beach	California
United States	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama
United States	Clinical Research Center of Cape Cod, Inc.	Hyannis	Massachusetts
United States	Institute of Arthritis Research	Idaho Falls	Idaho
United States	Diagnostic Rheumatology And Research PC	Indianapolis	Indiana
United States	Arthritis Clinic	Jackson	Tennessee
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Rheumatology Consultants, PLLC	Knoxville	Tennessee
United States	University of California San Diego Center for Innovative Therapy	La Jolla	California
United States	Florida Arthritis Center, P.L.	Lake Mary	Florida
United States	BayCare Outpatient Imaging at Bardmoor	Largo	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Bluegrass Community Research, Inc.	Lexington	Kentucky
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Little Rock Diagnostic Clinic, PA	Little Rock	Arkansas
United States	Osborne Research Center, LLC	Little Rock	Arkansas
United States	Keck Medicine of USC	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center, Drug Information Center	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of Southern California (USC) Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Southern California (USC) Norris Comprehensive Cancer Center-	Los Angeles	California
United States	Arthritis and Osteoporosis Associates, LLP	Lubbock	Texas
United States	Marietta Rheumatology Associates	Marietta	Georgia
United States	Clinical Pharmacology Study Group	Massachusetts	Nebraska
United States	Office of David R. Mandel, MD, Inc.	Mayfield	Ohio
United States	Loyola University Medical Center	Maywood	Illinois
United States	St. Luke's Clinic - Rhematology	Meridian	Idaho
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	Center for Arthritis and Rheumatic Diseases	Miami	Florida
United States	Trinity Health Center - Medical Arts	Minot	North Dakota
United States	Illinois Bone and Joint Institute, LLC	Morton Grove	Illinois
United States	Jeffrey Alper MD Research	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Delaware Arthritis and Osteoporosis Center	Newark	Delaware
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma Medical Research Foundation (OMRF)	Oklahoma City	Oklahoma
United States	Southern Tier Arthritis and Rheumatism	Olean	New York
United States	Heartland Clinic Research, Inc.	Omaha	Nebraska
United States	Westroads Clinical Research, Inc.	Omaha	Nebraska
United States	Gundersen Clinic, Ltd	Onalaska	Wisconsin
United States	Buffalo Rheumatology and Medicine, PLLC	Orchard Park	New York
United States	Dr. Jeffrey E. Poiley, MD , Office of	Orlando	Florida
United States	Millennium Research	Ormond Beach	Florida
United States	Kansas City Internal Medicine	Overland Park	Kansas
United States	Stanford University School of Medicine	Palo Alto	California
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Phoenix	Arizona
United States	DMI Research, Inc.	Pinellas Park	Florida
United States	Florida Arthritis & Osteoporosis Center	Port Richey	Florida
United States	Gulf Coast Medical Center	Port Richey	Florida
United States	Rheumatology Associates	Portland	Maine
United States	AAIR Research Center	Rochester	New York
United States	Rockford Health Physicians	Rockford	Illinois
United States	Rockford Orthopedic Associates	Rockford	Illinois
United States	Boice-Willis Clinic	Rocky Mount	North Carolina
United States	Office of Anupama Bhat, MD	Roseville	California
United States	Suncoast Medical Clinic	Saint Petersburg	Florida
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Pacific Arthritis Center Medical Group	Santa Maria	California
United States	Radiant Research, Inc.	Scottsdale	Arizona
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	The Seattle Arthritis Clinic	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Arthritis & Rheumatic Care Center	South Miami	Florida
United States	Miami Research Associates	South Miami	Florida
United States	Farmbrook Radiology Associates	Southfield	Michigan
United States	Springfield Clinic	Springfield	Illinois
United States	Springfield Clinic - Clinical Research	Springfield	Illinois
United States	Stanford Health Services - Medical Specialty Clinics	Stanford	California
United States	Tacoma Center of Arthritis Research, PS	Tacoma	Washington
United States	West Broward Rheumatology Associates, Inc.	Tamarac	Florida
United States	BayCare Medical Group, Inc	Tampa	Florida
United States	Rheumatology Associates of North Jersey	Teaneck	New Jersey
United States	New England Research Associates, LLC	Trumbull	Connecticut
United States	Catalina Pointe Clinical Research	Tucson	Arizona
United States	North Mississippi Medical Clinics, Inc.	Tupelo	Mississippi
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	The Vancouver Clinic, Inc. PS	Vancouver	Washington
United States	Lovelace Scientific Resources	Venice	Florida
United States	Venice Arthritis Center	Venice	Florida
United States	Deerbrook Medical Associates	Vernon Hills	Illinois
United States	Arthritis, Rheumatic & Back Disease Associates	Voorhees	New Jersey
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Via Christi Clinic, P.A.	Wichita	Kansas
United States	Rheumatic Disease Associates, Ltd.	Willow Grove	Pennsylvania
United States	Reliant Medical Group, Inc.	Worcester	Massachusetts
United States	Reliant Medical Group, Inc. at Worcester Medical Center	Worcester	Massachusetts
United States	Clinical Research Center of Reading LLP	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,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Costa Rica,  Croatia,  Czechia,  Denmark,  Dominican Republic,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  New Zealand,  Peru,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports	Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.; Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell	Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug
Primary	Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.	Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
Primary	Extension Period: Number of Participants With Laboratory Test Abnormalities	Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN).	Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
Primary	Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis	Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.	Includes AEs for every visit and up to 999 days after last dose of study drug
Primary	Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib	Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.	Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period
Secondary	Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses	The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.	Every visit until study completion
Secondary	Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses	ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.	Month 3, 6, 9 and 12 of Extension Period
Secondary	Initial Period: Area Under American College of Rheumatology (ACR) n Curve	No data were collected for this endpoint because it was removed from the protocol in a previous amendment.	Not applicable as no data were collected for this endpoint.
Secondary	Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])	Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.; DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.; The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of =3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.	Every visit until study completion
Secondary	Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12	DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.	Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period
Secondary	Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and =3.2	Percent participants with DAS28-4 (ESR) <2.6 and =3.2 and percent participants with DAS28-3 (CRP) <2.6 and =3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.; DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.; The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of =3.2 indicates low disease activity, and a score of <2.6 indicates disease remission.	Every visit until study completion
Secondary	Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2	DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission.	Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period
Secondary	Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.	Every visit until study completion
Secondary	Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12	HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.	Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period
Secondary	Initial Period: Short-Form-36 Health Survey (SF-36) Score	Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were "normed" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.	Every visit until study completion
Secondary	Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)	Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).; The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.	Every visit until study completion
Secondary	Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study	Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.; TSS=Total Sharp Score	Every 6 months until study completion
Secondary	Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by = 2-fold Increase in Antibody Concentrations	Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by =2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in =6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.; 95% CI is based on Clopper-Pearson exact method for response rate.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by = 4-fold Increase in Antibody Titers	Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by =4-fold increase in antibody titers from visit 2 (vaccination baseline) in =2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.; 95% CI is based on Clopper-Pearson exact method for response rate.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of = 1:40 in = 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4	Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of =1:40 in =2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.; The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.; 95% CI is based on Clopper-Pearson exact method for response rate.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by = 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4	Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by =2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in =6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.; 95% CI is based on Clopper-Pearson exact method for response rate.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by = 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4	Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as =4-fold increase in antibody titers from visit 2 (vaccination baseline) in =2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).; The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.; 95% CI is based on Clopper-Pearson exact method for response rate.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4	Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.; n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.; The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.; Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4	Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.; n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.; Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4	Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.; ug/mL=micrograms per milliliter	From vaccine sub-study visit 2 (baseline) to sub-study visit 4
Secondary	Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4	Mean influenza antibody titers at visits 3 and 4.	From vaccine sub-study visit 2 (baseline) to sub-study visit 4

External Links

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