AzTrials
AzTrials

Arthritis, RheumatoidPhase 3NCT00413699

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

A Phase 3 study testing CP-690,550 in people with Arthritis, Rheumatoid, run by Pfizer at 469 sites in 43 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
CP-690,550
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,488 participants
Where
469 sitesin 43 countries
Study dates
5 Feb 2007to 26 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
  • Vaccine sub-study visit
  • Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
  • Received any vaccine within 1 month prior to randomization in this study
  • Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.

Trial locations and contacts

469 sites in 43 countries.

469 sites in 43 countries

United States147 sites

  • The Center for Rheumatology, LLP

    Albany, New York, 12203

  • Office of John P. Lavery, MD, PA

    Allen, Texas, 75013

  • Asheville Rheumatology & Osteoporosis Research Associates, P.A.

    Asheville, North Carolina, 28801

  • Asheville Rheumatology & Osteoporosis Research Associates, PA

    Asheville, North Carolina, 28803

  • Arthritis and Rheumatology of Georgia P.C.

    Atlanta, Georgia, 30342

  • Austin Rheumatology Research, PA

    Austin, Texas, 78705

  • Arthritis and Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Ochsner Clinic Foundation - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Bronson Internal Medicine and Rheumatology

    Battle Creek, Michigan, 49015

  • East Penn Rheumatology Associates, PC

    Bethlehem, Pennsylvania, 18015

  • QUEST Research Institiute

    Bingham Farms, Michigan, 48025

  • Regional Rheumatology Associates

    Binghamton, New York, 13905

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • St. Luke's Clinic - Rheumatology

    Boise, Idaho, 83702

  • St. Luke's Clinic

    Boise, Idaho, 83702

  • St. Luke's Intermountain Research Center

    Boise, Idaho, 83702

  • Boulder Medical Center, PC

    Boulder, Colorado, 80304

  • Physician's Clinic of Iowa, P.C.

    Cedar Rapids, Iowa, 52403

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • Cincinnati Rheumatic Disease Study Group, Inc.

    Cincinnati, Ohio, 45219

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • Arthritis Associates and Osteoporosis Center of Colorado Springs

    Colorado Springs, Colorado, 80910

  • University Physicians - Woodrail Clinic

    Columbia, Missouri, 65203

  • University Of Missouri-Columbia

    Columbia, Missouri, 65212

  • Klein and Associates, MD, PA

    Cumberland, Maryland, 21502

  • Arthritis Care and Diagnostic Center, P.A.

    Dallas, Texas, 75231

  • Baylor Research Institute

    Dallas, Texas, 75231

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • STAT Research, Inc.

    Dayton, Ohio, 45417

  • Allergy, Asthma, Arthritis, & Lung

    Daytona Beach, Florida, 32114

  • Physicians Research Alliance LLC

    DeBary, Florida, 32713

  • Jeffrey D. Lieberman, MD, PC

    Decatur, Georgia, 30333

  • Medical Associates Clinic, PC

    Dubuque, Iowa, 52002

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Arthritis and Rheumatology Consultants, P.A.

    Edina, Minnesota, 55435

  • Med Investigations, Inc.

    Fair Oaks, California, 95628

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-5353

  • University of North Texas Health Science Center at Fort Worth

    Fort Worth, Texas, 76107

  • The Arthritis Treatment Center

    Frederick, Maryland, 21702

  • Southeastern Arthritis Center

    Gainesville, Florida, 32607

  • Southeastern Imaging and Diagnostics

    Gainesville, Florida, 32607

  • Southeastern Integrated Medical PL d/b/a Florida Medical Research Institute

    Gainesville, Florida, 32607

  • Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute

    Gainesville, Florida, 32607

  • Arthrocare, Arthritis Care & Research, PC

    Gilbert, Arizona, 85234

  • Piedmont Arthritis Clinic, PA

    Greenville, South Carolina, 29601

  • Arthritis & Osteoporosis Center, PC

    Hamden, Connecticut, 06518

  • PMG Research Hickory, LLC

    Hickory, North Carolina, 28602

  • PMG Research of Hickory

    Hickory, North Carolina, USA 28602

  • Arthritis Associates, PLLC

    Hixson, Tennessee, 37343

  • CHI St. Vincent Medical Group Hot Springs

    Hot Springs, Arkansas, 71913

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77034

  • Houston Institute for Clinical Research

    Houston, Texas, 77074

  • Talbert Medical Group

    Huntington Beach, California, 92646

  • Rheumatology Associates of North Alabama, PC

    Huntsville, Alabama, 35801

  • Clinical Research Center of Cape Cod, Inc.

    Hyannis, Massachusetts, 02601

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Diagnostic Rheumatology And Research PC

    Indianapolis, Indiana, 46227

  • Arthritis Clinic

    Jackson, Tennessee, 38305

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • Rheumatology Consultants, PLLC

    Knoxville, Tennessee, 37909-1907

  • University of California San Diego Center for Innovative Therapy

    La Jolla, California, 92093

  • Florida Arthritis Center, P.L.

    Lake Mary, Florida, 32746

  • BayCare Outpatient Imaging at Bardmoor

    Largo, Florida, 33777

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Bluegrass Community Research, Inc.

    Lexington, Kentucky, 40504

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • Osborne Research Center, LLC

    Little Rock, Arkansas, 72201

  • Little Rock Diagnostic Clinic, PA

    Little Rock, Arkansas, 72205

  • Keck Medicine of USC

    Los Angeles, California, 90033

  • University of Southern California (USC) Norris Comprehensive Cancer Center-

    Los Angeles, California, 90033

  • University of Southern California (USC) Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095-6984

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Arthritis and Osteoporosis Associates, LLP

    Lubbock, Texas, 79424

  • Marietta Rheumatology Associates

    Marietta, Georgia, 30060

  • Clinical Pharmacology Study Group

    Massachusetts, Nebraska, 01605

  • Office of David R. Mandel, MD, Inc.

    Mayfield, Ohio, 44143

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • St. Luke's Clinic - Rhematology

    Meridian, Idaho, 83642

  • Southwest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • Center for Arthritis and Rheumatic Diseases

    Miami, Florida, 33173

  • Trinity Health Center - Medical Arts

    Minot, North Dakota, 58701

  • Illinois Bone and Joint Institute, LLC

    Morton Grove, Illinois, 60053

  • Jeffrey Alper MD Research

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70115

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Delaware Arthritis and Osteoporosis Center

    Newark, Delaware, 19713

  • Ocala Rheumatology Research Center

    Ocala, Florida, 34474

  • Oklahoma Medical Research Foundation (OMRF)

    Oklahoma City, Oklahoma, 73104

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Southern Tier Arthritis and Rheumatism

    Olean, New York, 14760

  • Westroads Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Heartland Clinic Research, Inc.

    Omaha, Nebraska, 68134

  • Gundersen Clinic, Ltd

    Onalaska, Wisconsin, 54650

  • Buffalo Rheumatology and Medicine, PLLC

    Orchard Park, New York, 14127

  • Dr. Jeffrey E. Poiley, MD , Office of

    Orlando, Florida, 32804

  • Millennium Research

    Ormond Beach, Florida, 32174

  • Kansas City Internal Medicine

    Overland Park, Kansas, 66209

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona, 85032

  • DMI Research, Inc.

    Pinellas Park, Florida, 33782

  • Florida Arthritis & Osteoporosis Center

    Port Richey, Florida, 34668

  • Gulf Coast Medical Center

    Port Richey, Florida, 34668

  • Rheumatology Associates

    Portland, Maine, 04102

  • AAIR Research Center

    Rochester, New York, 14618

  • Rockford Health Physicians

    Rockford, Illinois, 61103-3692

  • Rockford Orthopedic Associates

    Rockford, Illinois, 61114

  • Boice-Willis Clinic

    Rocky Mount, North Carolina, 27804

  • Office of Anupama Bhat, MD

    Roseville, California, 95661

  • San Diego Arthritis Medical Clinic

    San Diego, California, 92108

  • Pacific Arthritis Center Medical Group

    Santa Maria, California, 93454

  • Radiant Research, Inc.

    Scottsdale, Arizona, 85251

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Rheumatology Associates

    Seattle, Washington, 98122

  • The Seattle Arthritis Clinic

    Seattle, Washington, 98133

  • Arthritis & Rheumatic Care Center

    South Miami, Florida, 33143

  • Miami Research Associates

    South Miami, Florida, 33143

  • Farmbrook Radiology Associates

    Southfield, Michigan, 48034

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Clinic - Clinical Research

    Springfield, Illinois, 62703

  • Suncoast Medical Clinic

    St. Petersburg, Florida, 33782

  • Stanford Health Services - Medical Specialty Clinics

    Stanford, California, 94305

  • Tacoma Center of Arthritis Research, PS

    Tacoma, Washington, 98405

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida, 33321

  • BayCare Medical Group, Inc

    Tampa, Florida, 33614

  • Rheumatology Associates of North Jersey

    Teaneck, New Jersey, 07666

  • New England Research Associates, LLC

    Trumbull, Connecticut, 06611

  • Catalina Pointe Clinical Research

    Tucson, Arizona, 85704

  • North Mississippi Medical Clinics, Inc.

    Tupelo, Mississippi, 38801

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • The Vancouver Clinic, Inc. PS

    Vancouver, Washington, 98664

  • Lovelace Scientific Resources

    Venice, Florida, 34292

  • Venice Arthritis Center

    Venice, Florida, 34292

  • Deerbrook Medical Associates

    Vernon Hills, Illinois, 60061

  • Arthritis, Rheumatic & Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67203

  • Via Christi Clinic, P.A.

    Wichita, Kansas, 67208

  • Rheumatic Disease Associates, Ltd.

    Willow Grove, Pennsylvania, 19090

  • Reliant Medical Group, Inc.

    Worcester, Massachusetts, 01605

  • Reliant Medical Group, Inc. at Worcester Medical Center

    Worcester, Massachusetts, 01608

  • Clinical Research Center of Reading LLP

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Canada22 sites

  • Rheumatology Research Associates Ltd.

    Edmonton, Alberta, T5M 0H4

  • Dr. William G. Bensen Medicine Professional Corporation

    Hamilton, Ontario, L8N 1Y2

  • Office of Dr. Fernando Bianchi

    Hamilton, Ontario, L8N 1Y2

  • Cividino Medicine Professional Corporation

    Hamilton, Ontario, L8N 2B6

  • KW Musculoskeletal Research Inc.

    Kitchener, Ontario, N2M 5N6

  • St Joseph's Health Centre

    London, Ontario, N6A 4V2

  • Credit Valley Rheumatology

    Missisauga, Ontario, L5M 2V8

  • Institut de Rhumatologie de Montreal

    Montreal, Quebec, H2L 1S6

  • The Arthritis Program Research Group Inc.

    Newmarket, Ontario, L3Y 3R7

  • Rheumatology and Osteoporosis Clinic

    Oakville, Ontario, L6M 4J2

  • Rheumatology Research Associates

    Ottawa, Ontario, K1H 1A2

  • West Island Rheumatology Research Associates

    Pointe-Claire, Quebec, H9R 3J1

  • Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.

    Québec, Quebec, G1V 3M7

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W4R4

  • Arthritis Research Center, Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Niagara Peninsula Arthritis Centre

    St. Catharines, Ontario, L2N 7E4

  • Nexus Clinical Research

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Centre de Recherche Musculo-Squelettique

    Trois-Rivières, Quebec, G8Z 1Y2

  • Dr. Alice Klinkhoff, Inc.

    Vancouver, British Columbia, V5Z 1L7

  • Percuro Clinical Research Limited

    Victoria, British Columbia, V8V 3P9

  • Clinical Research and Arthritis Centre

    Windsor, Ontario, N8X 5A6

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

China20 sites

  • Beijing Chaoyang Hospital, Capital University of Medical Science

    Beijing, Beijing Municipality, 100020

  • Peking University People's Hospital/Rheumatology and Immunology Department

    Beijing, 100044

  • PLA General Hospital

    Beijing, 100853

  • Xiangya Hospital of Centre-south University

    Changsha, Hunan, 410008

  • Si Chuan Huaxi Hospital

    Chengdu, 610041

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310009

  • Anhui Province Hospital

    Hefei, 230001

  • An Hui Medical University 1st Hospital

    Hefei, 230022

  • QiLu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200001

  • Shanghai Changhai Hospital

    Shanghai, 200433

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • "Department of Infectious Diseases & Immunology

    Tianjin, 300052

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Xijing Hospital, The Fourth Military Medical University

    Xi'an, Shaan'xi, 710032

Other trials in China

Czechia19 sites

  • X-MEDICA s.r.o.

    Brno, 61300

  • Revmacentrum MUDr. Mostera, s.r.o.

    Brno, 615 00

  • Fakultni Nemocnice Brno, Interni hematoonkologicka klinika

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • HESTE s.r.o. Revmatologie

    Česká Lípa, 470 01

  • MEDIPONT Plus sro

    České Budějovice, 370 01

  • L.K.N. Arthrocentrum, s.r.o.

    Hlučín, 748 01

  • ARTMEDI UPD s r.o

    Hostivice, 253 01

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Revmatologicka ambulance

    Ostrava, 70800

  • ARTHROMED, s. r. o. Revmatologicka ambulance

    Pardubice, 530 02

  • Revmatologicky ustav

    Prague, 12850

  • Revmatologicka ambulance

    Prague, 140 00

  • Fakultni Thomayerova nemocnice s poliklinikou

    Prague, 140 59

  • Nuselska poliklinika RTG

    Prague, 14000

  • Revmatologicka ambulance

    Prague, 14000

  • Affidea Praha, s.r.o.

    Praha 11 - Chodov, 148 00

  • Nemocnice Atlas, a.s.

    Zlín, 760 01

  • PV-Medical s.r.o.

    Zlín, 760 01

Other trials in Czechia

Russia19 sites

  • State Healthcare Institution Regional Clinical Hospital

    Barnaul, 656024

  • State Healthcare Institution Regional Clinical Hospital for War Veterans

    Kemerovo, 650099

  • Russian State Medical University Moscow Faculty City Clinical Hospital #4

    Moscow, 115093

  • Rheumatology Research Institute of Russian Academy of Medical Sciences

    Moscow, 115522

  • City Clinical Hospital # 1

    Novosibirsk, Novosibirsk Oblast, 630047

  • "Consultative Diagnostic Rheumatology Center ""Healthy Joints"", LLC"

    Novosibirsk, Novosibirsk Oblast, 630091

  • GUZ Republican Hospital n.a. Baranov

    Petrozavodsk, 185019

  • State Healthcare Institution City Hospital # 40 of Administrative Health Resort District

    Saint Petersburg, Sestroretsk, Russia, 197706

  • Saint-Petersburg State Budgetary Healthcare Institution "Clinical Rheumathology Hospital #25"

    Saint Petersburg, 190068

  • Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency

    Saint Petersburg, 194291

  • Federal North-West Medical Research Centre

    Saint Petersburg, 197341

  • St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85

    Saint Petersburg, 198260

  • Smolensk State Medical Academy

    Smolensk, Smolensk Oblast, 214019

  • Regional State Budget Institution Of Healthcare

    Tomsk, 634063

  • Regional State Budgetary Healthcare Institution of Tomsk Regional Clinical Hospital

    Tomsk, 634063

  • State Healthcare Institution

    Yekaterinburg, 620102

  • State Educational Institution of Higher Professional Education Ural State Medical Academy of Federal

    Yekaterinburg, 620149

  • State Educational Institution of Higher Professional Education

    Yekaterinburg, 620149

  • Ltd.Medical Association "Novaya Bolnitsa"

    Yekaterinburg, 620219

Other trials in Russia

Germany18 sites

  • Privat-Praxis

    Aachen, 52064

  • Charite Campus Mitte, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

    Berlin, 10117

  • Schlosspark-Klinik Innere Medizin II, Rheumatologie

    Berlin, 14059

  • Ambulantes Rheumazentrum Dr Soerensen

    Berlin, 14163

  • Universitaetsklinikum Koeln Klinik I fuer Innere Medizin, Haus 16, 1. OG, Raum 1.008

    Cologne, 50937

  • Krankenhaus Friedrichstadt, I. Medizinische Klinik

    Dresden, 01067

  • Studienambulanz Universitaetsklinikum Erlangen Medizinische Klinik 3

    Erlangen, 91054

  • J.W.-Goethe-Universitaetsklinik, Medizinische Klinik II, Abteilung fuer Rheumatologie

    Frankfurt am Main, 60590

  • Schwerpunktpraxis Rheumatologie

    Halle, 06108

  • Schoen Klinik Hamburg-Eilbek

    Hamburg, 22081

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Universitaetsklinik Leipzig, Klinik fur Gastroenterologie und Rheumatologie, Sektion Rheumatologie

    Leipzig, 04103

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Klinikum der Universitaet Muenchen, Campus Innenstadt, Rheuma-Einheit

    München, 80336

  • Arztpraxis, Internist - Rheumatologie

    Nuremberg, 90429

  • Rheumaforschung- Studienambulanz

    Ratingen, 40882

  • Schwerpunktpraxis fuer Rheumatologie

    Rheine, 48431

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Mexico18 sites

  • Investigacion y Biomedica de Chihuahua, SC

    Chihuahua City, 31000

  • Centro de Investigacion Clinica Especializada, SC

    Coyoacán, Mexico City, 04030

  • Fundacion El Hospitalito

    Cuernavaca, Morelos, 62170

  • Centro Integral en Reumatologia, SA de CV

    Guadalajara, Jalisco, 44160

  • Unidad de Investigacion en Enfermedades Cronico Degenerativas

    Guadalajara, Jalisco, 44620

  • Unidad Reumatologica Las Americas SCP

    Mérida, Yucatán, 97000

  • Centro Medico Toluca

    Metepec, State of Mexico, 52140

  • Hospital Angeles del Pedregal

    Mexico City, Mexico City, 10700

  • Hospital Angeles Mocel

    Mexico City, 11850

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

  • Hospital Universitario Doctor Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64020

  • Centro de Investigacion Clinica de Morelia

    Morelia, Michoacán, 58070

  • Clinica de Enfermedades Cronicas y Procedimientos Especiales SC

    Morelia, Michoacán, 58249

  • Centro Reumatologico Queretaro

    Querétaro, 76178

  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.

    San Luis Potosí City, 78213

  • Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Reumatologia y Osteoporosis

    San Luis Potosí City, 78240

  • Centro de Investigacion del Noroeste

    Tijuana, BAJA California Norte, 22010

  • Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC

    Torreón, Coahuila, 27000

Other trials in Mexico

Spain15 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario De La Paz

    Madrid, 28046

  • Hospital Civil. Hospital Regional Universitario Carlos Haya

    Málaga, 29009

  • Hospital de Merida

    Mérida, Badajoz, 06800

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Nuestra Senora de la Esperanza

    Santiago de Compostela, A Coruna, 15705

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Hospital El Tomillar

    Seville, 41700

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

South Korea14 sites

  • Dong-A University Hospital

    Busan, 49201

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Eulji University Hospital

    Daejeon, Republic of Korea, 35233

  • Chonnam National University Hospital

    Gwangju, 61469

  • Inha University Hospital

    Jung-gu, Incheon, 22332

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University Health System

    Seoul, 03722

  • Hanyang University Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center-University of Ulsan College of Medicine

    Seoul, 05505

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital-Yonsei University Health System

    Seoul, 06273

  • Gangnam Severance Hospital

    Seoul, 06273

  • Seoul St. Mary's Hospital-The Catholic University of Korea

    Seoul, 06591

Other trials in South Korea

Poland11 sites

  • "ZDROWIE OSTEO-MEDIC" s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik

    Bialystok, 15-351

  • ClinicMed Badurski i wspolnicy Spolka Jawna

    Bialystok, 15-879

  • NSZOZ Medicus II

    Cieszyn, 43400

  • Szpital im. Teodora Dunina

    Kościan, 64-000

  • Krakowskie Centrum Medyczne NZOZ

    Krakow, 31-501

  • Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

    Poznan, 60-773

  • Wojewodzki Zespol Reumatologiczny im. dr Jadwigi Titz-Kosko

    Sopot, 81-759

  • Nzoz "Nasz Lekarz"

    Torun, 87-100

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 01-192

  • Rheuma-Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy

    Warsaw, 02-118

  • SYNEXUS Polska Sp. z.o.o.

    Wroclaw, 50-088

Other trials in Poland

Brazil10 sites

  • Centro de Estudos em Terapias Inovadoras

    Curitiba, Paraná, 80030-110

  • Centro de Estudos em Terapias Inovadoras

    Curitiba, Paraná, 80060-240

  • CIP - Centro Internacional de Pesquisa

    Goiânia, Goiás, 74110-120

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

    São Paulo, São Paulo, 05403-010

  • IMA Brasil -Instituto de Pesquisa Clinica e Medicina Avancada

    São Paulo, São Paulo, 05437-010

  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda

    São Paulo, 04266-010

Other trials in Brazil

Bulgaria10 sites

  • Revmatologichen kabinet, DKTs Sveti Pantaleimon OOD

    Pleven, 5800

  • Revmatologichno Otdelenie, MBAL - Plovdiv

    Plovdiv, 4000

  • UMBAL Kaspela Plovdiv

    Plovdiv, 4002

  • MBAL Akta Medika OOD

    Sevlievo, 5400

  • Clinic of Cardiology and Rheumatology Military Medical Academy

    Sofia, 1606

  • Clinic of Rheumatology Multiprofile Hospital for Active treatment Sveti Ivan Rilski

    Sofia, 1612

  • MBAL Sveti Ivan Rilski Sofia

    Sofia, 1612

  • DKTs "Sveta Anna" Sofia, Konsultativen kabinet po Revmatologia

    Sofia, 1709

  • DKTs "Sveta Anna", Sofia / Diagnostic Consultative Center "Sveta Anna"

    Sofia, 1709

  • MOBAL "D-r Stefan Cherkezov" AD,

    Veliko Tarnovo, 5000

Other trials in Bulgaria

India10 sites

  • Rheumatic Diseases Clinic

    Ahmedabad, Gujarat, 380009

  • Shalby Hospitals

    Ahmedabad, Gujarat, 380015

  • Chanre Rheumatology and Immunology Center and Research

    Bangalore, Karnataka, 560 003

  • St. John's Medical College and Hospital.

    Bangalore, Karnataka, 560 034

  • Shirdi Sai Hospital

    Bangalore, Karnataka, 560 054

  • Chanre Rheumatology & Immunology Center & Research

    Bangalore, Karnataka, 560 079

  • Mahavir Hospital & Research Center

    Hyderabad, Andhra Pradesh, 500 004

  • Arthritis Research and Care Foundation Centre for Rheumatic Diseases

    Pune, Maharashtra, 411 001

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, Maharashtra, 411001

  • Krishna Institute of Medical Sciences Ltd

    Secunderabad, Telangana, 500 003

Other trials in India

Slovakia10 sites

  • Reumatologicka ambulancia, Poliklinika Ruzinov

    Bratislava, 82606

  • NOVAPHARM s.r.o -Zeleznicna NaP, Reumatologicka ambulancia

    Bratislava, 832 99

  • AAGS, s.r.o. , nestatne zdravotnicke zariadenie

    Dunajská Streda, 92901

  • Interna a reumatologicka ambulancia

    Košice, 040 01

  • Ecclesia, s.r.o Reumatologicka ambulancia

    Nové Zámky, 94001

  • Narodny Ustav Reumatickych Chorob

    Piešťany, 92112

  • Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.

    Poprad, 058 01

  • Reumatologicka ambulancia, REUMEX, s.r.o.

    Rimavská Sobota, 979 01

  • Reumatologicka ambulancia, Nestatne zdravotnicke zariadenie

    Senica, 905 01

  • Nestatna reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.

    Žilina, 010 01

Other trials in Slovakia

Ukraine10 sites

  • Municipal Establishment of Health Care "Kharkiv City Clinical Hospital #8", Dept. of Rheumatology

    Kharkiv, 61178

  • State Institution Republican Clinical Hospital of the Ministry of Health of Ukraine

    Kyiv, 04053

  • State Establishment "Institute of Gerontology of NAMS of Ukraine n.a. D.F. Chebotareva"

    Kyiv, 04114

  • Municipal City Clinical Hospital #4, Policlinic Care

    Lviv, 79011

  • "Multifield Medical Center of Odesa National Medical University ""University Clinic #1"""

    Odesa, 65026

  • Multifield Medical Center of Odesa National Medical University "University Clinic #1"

    Odesa, 65026

  • Crimean Republican Institution "Clinical Territorial Medical Association "University Clinic",

    Simferopol, Autonomous Republic of Crimea, 95017

  • CRIMEAN Republican Institution, "Clinical Hospital n.a. M.O. Semashko"

    Simferopol Crimea, Ukraine, 95017

  • Vinnitsa Regional Clinical Hospital n.a. Pirogov

    Vinnitsa, 21018

  • Municipal Establishment "City Hospital#7of Zaporizhzhia State Medical University

    Zaporizhzhya, 69118

Other trials in Ukraine

Chile9 sites

  • Clinica Santa Maria, Seccion Reumatologia

    Providencia, Santiago, RM, 7530206

  • Hospital Regional de Rancagua

    Rancagua, 2841959

  • Centro de Estudios Reumatologicos

    Santiago, RM, 7501126

  • Consulta Privada Dra. Marta Aliste

    Santiago, RM, 7510186

  • Centro de Diagnostico y Tratamiento Hospital San Borja Arriaran

    Santiago, Santiago Metropolitan, 8360156

  • Clinica Santa Maria

    Santiago, 7530206

  • Consulta Privada Dra. Lucia Ponce

    Temuco, Araucania, 4790928

  • Hospital Base Valdivia, Policlinico de Reumatologia

    Valdivia, Region XIV, 5090145

  • Estudios Clinicos V Region

    Vina Del Mar, V Region, 2520997

Other trials in Chile

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Chang Gung Medical Foundation-Linkou Branch

    Kwei-Shan, Taoyuan County, 333

  • Chang Gung Medical Foundation-

    Niao Sung Hsiang, Kaohsiung County, 833

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Argentina7 sites

  • OMI- Organizacion Medica de Investigacion

    Buenos Aires, Buenos Aires F.D., C1015ABO

  • Centro de Investigaciones Reumatologicas y Osteologicas -CIRO

    Buenos Aires, Buenos Aires F.D., C1114AAH

  • Hospital Sirio Libanes

    Buenos Aires, 1419AHN

  • OMI - Organización Médica de Investigación

    Buenos Aires, C1015ABO

  • Saint Dennis Medical Group S.A.

    Buenos Aires, C1034ACO

  • Hospital Sirio Libanes

    Buenos Aires, C1419AHN

  • Consultorios Reumatologicos Pampa

    Buenos Aires, C1428DZF

Other trials in Argentina

Australia7 sites

  • Rheumatology Research

    Cairns, Queensland, 4870

  • Optimus Clinical Research Pty. Ltd.

    Kogarah, New South Wales, 2217

  • Emeritus Research

    Malvern East, Victoria, 3145

  • Rheumatology Research Unit Sunshine Coast

    Maroochydore, Queensland, 4558

  • Goatcher Clinical Research Unit

    Perth, Western Australia, WA 6000

  • Royal North Shore Hospital

    St Leonards, NSW2065

  • Queen Elizabeth Hospital, Department of Rheumatology

    Woodville, South Australia, 5011

Other trials in Australia

Malaysia7 sites

  • Hospital Selayang

    Batu Caves, Selangor, 68100

  • Queen Elizabeth Hospital

    Kota Kinabalu, Sabah, 88586

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

  • Sunway Medical Centre

    Petaling Jaya, Selangor, 46150

  • Hospital Putrajaya, Dept. of Medicine

    Putrajaya, Kuala Lumpur, 62250

  • Hospital Tuanku Ja'afar

    Seremban, Negeri Sembilan, 70300

  • Subang Jaya Medical Centre

    Subang Jaya, Selangor, 47500

Other trials in Malaysia

Philippines7 sites

  • Angeles University Foundation Medical Center

    Angeles City, Pampanga, 2009

  • Chong Hua Hospital

    Cebu City, 6000

  • De La Salle University Health Sciences Campus Clinical Epidemiology Unit

    Dasmariñas, Cavite, 4114

  • Southern Philippine Medical Center

    Davao City, 8000

  • University of Perpetual Help Rizal Dalta Medical Center

    Las Piñas, Philippines, 1742

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4217

  • University of Santo Tomas Hospital

    Manila, 1008

Other trials in Philippines

France6 sites

  • Hopital Nord

    Amiens, 80000

  • Hôpital Nord

    Amiens, 80000

  • *CHR Hopital Porte Madeleine IPROS

    Orléans, 45000

  • CHR ORLEANS - Service IPROS

    Orléans, 45032

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hopital Cochin

    Paris, 75014

Other trials in France

Sweden6 sites

  • Falu lasarett

    Falun, 791 82

  • Lanssjukhuset Ryhov

    Jönköping, 551 85

  • Skanes Universitetssjukhus i Malmo Reumamottagningen

    Malmö, 205 02

  • Sundsvalls Sjukhus

    Sundsvall, 851 86

  • Norrlands Universitetssjukhus

    Umeå, 901 85

  • Akademiska University Hospital

    Uppsala, 75185

Other trials in Sweden

Croatia5 sites

  • University Hospital Center Osijek

    Osijek, 31000

  • University Hospital Split, Department for Internal Medicine, Division of Clinical Rheumatology

    Split, 21000

  • Clinical Hospital "Sveti Duh"

    Zagreb, 10 000

  • University Hospital Center "Zagreb"

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Hungary5 sites

  • Drug Research Center Kft

    Balatonfüred, 8230

  • Orszagos Reumatologiai Es Fizioterapias Intezet

    Budapest, 1023

  • Revita Reumatologiai Rendelo

    Budapest, 1027

  • Synexus Magyarorszag Kft.

    Budapest, H-1036

  • MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles

    Szolnok, 5000

Other trials in Hungary

Thailand5 sites

  • Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

    Amphoe Mueang, Chiang Mai, 50200

  • Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital

    Bangkok, 10400

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Division of Allergy-Immunology-Rheumatology, Department of Medicine, Faculty of Medicine

    Muang District, Khonkaen, 40002

  • Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital

    Rajathevee, Bangkok, 10400

Other trials in Thailand

Colombia4 sites

  • Centro de Reumatologia y Ortopedia S.A.S.

    Barranquilla, Atlántico

  • Riesgo de Fractura S.A.

    Bogota D.C., Cundinamarca

  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S CIREEM S.A.S

    Bogota, D.C., Cundinamarca

  • Servimed S.A.S.

    Bucaramanga, Santander Department, 680003

Other trials in Colombia

Costa Rica4 sites

  • Centro de Reumatologia y Osteoporosis, Cartago

    Cartago

  • Hospital Cima San Jose

    San José, 00000

  • Hospital Cima San Jose

    San José

  • Oficina Privada Del Colegio deMedicos

    San José

Other trials in Costa Rica

United Kingdom4 sites

  • The Royal Wolverhampton NHS Trust

    Cannock, WS11 5XY

  • Dudley Group of Hospitals NHS Trust

    Dudley, WEST Midlands, DY1 2HQ

  • Wirral University Teaching Hospital NHS Foundation Trust-Arrowe Park Hospital

    Metropolitan Borough of Wirral, CH49 5PE

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Austria3 sites

  • Medizinische Universitaet Wien / AKH

    Vienna, A-1090

  • Rheuma-Ordination Favoriten

    Vienna, A-1100

  • Sozialmedizinisches Zentrum Sued - Kaiser Franz Josef Spital

    Vienna, A-1100

Other trials in Austria

Belgium3 sites

  • Universitair Ziekenhuis Gent - Reumatologie

    Ghent, Oost-vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • Centre Hospitalier Universitaire de Liège

    Liège, 4020

Other trials in Belgium

Finland3 sites

  • Helsingin Reumakeskus Oy

    Helsinki, 00120

  • Kiljavan Laaketutkimus Oy

    Hyvinkää, 05800

  • TAYS/Reumakeskus/Finn-Medi 1

    Tampere, 33520

Other trials in Finland

New Zealand3 sites

  • The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital

    Christchurch, 8022

  • Waikato Hospital, Rheumatology

    Hamilton, 3240

  • Clinical Trials Unit, Timaru Hospital

    Timaru, 7910

Other trials in New Zealand

Peru3 sites

  • Hospital Nacional IV Alberto Sabogal Sologuren

    Callao, C-02

  • Centro Medico Corpac/Investigaciones en Reumatologia

    Lima, L-27

  • Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR

    Lima, L-27

Other trials in Peru

Puerto Rico3 sites

  • Ponce School Of Medicine

    Ponce, 00716

  • Edificio Parra

    Ponce, 00717-1321

  • Mindful Medical Research

    San Juan, PR, 00918

Other trials in Puerto Rico

Turkey (Türkiye)3 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Ege University Medical Faculty

    Bornova, İzmir, 35100

  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

    Izmir, 35340

Other trials in Turkey (Türkiye)

Greece2 sites

  • General Hospital Euromedica "KYANOUS STAVROS"

    Thessaloniki, 54636

  • 424 General Army Hospital

    Thessaloniki, 56429

Other trials in Greece

Italy2 sites

  • A.O.U. Careggi - SOD Medicina Interna 1 e Reumatologia

    Florence, FI, 50139

  • U.O. Clinica Reumatologica

    Genova, 16132

Other trials in Italy

Romania2 sites

  • Spitalul Clinic "Sf. Maria"

    Bucharest, 011172

  • Spitalul Clinic De Recuperare

    Iași, 700661

Other trials in Romania

Bosnia and Herzegovina1 site

  • University Clinical Center Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Denmark1 site

  • Frederiksberg Hospital

    Frederiksberg, 2000

Other trials in Denmark

Dominican Republic1 site

  • Hospital Central de las Fuerzas Armadas

    Santo Domingo, 10119

Other trials in Dominican Republic

Ireland1 site

  • St. Vincent's University Hospital

    Elm Park, Dublin

Other trials in Ireland

About this study

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

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

Being tested
CP-690,550
Keywords
long-term, open-label, safety
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-690,550Drug

    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-690,550Drug

    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.

Study groups in NCT00413699
Study groupRoleWhat they receive
Open-Label Active Treatment Enrolled from Phase 2ExperimentalPatients enrolling from Phase 2 studies
Receives: Drug: CP-690,550
Open-Label Active Treatment Enrolled from Phase 3ExperimentalPatients enrolling from Phase 3 studies
Receives: Drug: CP-690,550

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug

  2. 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.

    Measured: Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

  3. 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).

    Measured: Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

  4. 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.

    Measured: Includes AEs for every visit and up to 999 days after last dose of study drug

  5. 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.

    Measured: 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 outcomes (21)

  1. 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.

    Measured: Every visit until study completion

  2. 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.

    Measured: Month 3, 6, 9 and 12 of Extension Period

  3. 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.

    Measured: Not applicable as no data were collected for this endpoint.

  4. 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.

    Measured: Every visit until study completion

  5. 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.

    Measured: Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period

  6. 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.

    Measured: Every visit until study completion

  7. 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.

    Measured: Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period

  8. 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.

    Measured: Every visit until study completion

  9. 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.

    Measured: Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period

  10. 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.

    Measured: Every visit until study completion

  11. 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.

    Measured: Every visit until study completion

  12. 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

    Measured: Every 6 months until study completion

  13. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  14. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  15. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  16. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  17. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  18. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  19. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  20. 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

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

  21. 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.

    Measured: From vaccine sub-study visit 2 (baseline) to sub-study visit 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2006 (estimated)
  2. Study start5 Feb 2007
  3. Primary completion30 Nov 2016
  4. Study completion26 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413699
Sponsor's protocol ID
A3921024
Other IDs
2006-005035-19
Status last verified
Oct 2018
First submitted
18 Dec 2006
Last updated
30 Oct 2018
Data monitoring committee
Yes

Publications

  • Strand V, Schulze-Koops H, Al-Emadi S, Kinch CD, Gruben D, Germino R, Connell CA, Mysler E. Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials. BMJ Open. 2025 Dec 24;15(12):e082366. doi: 10.1136/bmjopen-2023-082366.

    PubMed 41448717

  • Pope J, Finckh A, Silva-Fernandez L, Mandl P, Fan H, Rivas JL, Valderrama M, Montoro M. Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention. Open Access Rheumatol. 2024 Jun 11;16:115-126. doi: 10.2147/OARRR.S446431. eCollection 2024.

    PubMed 38883150

  • Curtis JR, Wollenhaupt J, Tas SW, Chatzidionysiou K, Wang L, Roberts K, Tsekouras V. Determinants of tofacitinib discontinuation in adult patients with rheumatoid arthritis during long-term extension studies up to 9.5 years. Rheumatol Adv Pract. 2024 May 11;8(2):rkae063. doi: 10.1093/rap/rkae063. eCollection 2024.

    PubMed 38854417

  • Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

    PubMed 37453736

  • Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.

    PubMed 36931693

  • Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.

    PubMed 36601090

  • Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.

    PubMed 36600185

  • Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.

    PubMed 36526796

  • Mueller RB, Schulze-Koops H, Furst DE, Cohen SB, Kwok K, Wang L, Killeen T, von Kempis J. Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel). Clin Rheumatol. 2022 Apr;41(4):1045-1055. doi: 10.1007/s10067-021-05908-z. Epub 2022 Jan 1.

    PubMed 34973077

  • Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

    PubMed 34870800

  • Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

    PubMed 33127856

  • van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.

    PubMed 33057725

  • Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

    PubMed 32816215

  • Kaine J, Tesser J, Takiya L, DeMasi R, Wang L, Snyder M, Soma K, Fan H, Bandi V, Wollenhaupt J. Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis. Clin Rheumatol. 2020 Jul;39(7):2127-2137. doi: 10.1007/s10067-020-04956-1. Epub 2020 Feb 12.

    PubMed 32048083

  • Wollenhaupt J, Lee EB, Curtis JR, Silverfield J, Terry K, Soma K, Mojcik C, DeMasi R, Strengholt S, Kwok K, Lazariciu I, Wang L, Cohen S. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019 Apr 5;21(1):89. doi: 10.1186/s13075-019-1866-2.

    PubMed 30953540

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CP-690,550 in people with Arthritis, Rheumatoid, run by Pfizer at 469 sites in 43 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 469 sites in United States, Canada, China, Czechia, Russia and 38 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (time frame: Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00413699, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.

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