694
Participants
Start Date
September 1, 2016
Primary Completion Date
November 19, 2018
Study Completion Date
December 17, 2018
CP-690,550
"During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.~During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above."
Methotrexate
"During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.~During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above."
Placebo
During the double-blind phase, subjects who are randomized to the comparison arm will receive 11mg QD tofacitinib and the placebo capsules matching for methotrexate.
Revita Rendelo, Budapest
Qualiclinic Kft., Budapest
Far Eastern University - Nicanor Reyes Medical Foundation, Marian Medical Arts Bldg, Quezon City
National Multiprofile Transport Hospital Tsar Boris III, Sofia
Medical Centre Synexus Sofia EOOD, Sofia
Optimus Clinical Research Pty Ltd, Kogarah
Genesis Research Services Pty Ltd, Broadmeadow
Emeritus Research, Melbourne
CRU Hungary Kft., Miskolc
ReumaClinic, Genk
Multiprofile Hospital for Active Treatment - Plovdiv AD, Rheumatology Department, Plovdiv
Multiprofile Hospital for Active Treatment Trimontium OOD, Plovdiv
University Multiprofile Hospital for Active Treatment - Kaspela EOOD, Plovdiv
St. Augustine's Hospital, Durban
Mary Mediatrix Medical Center, Lipa City
Rheumatology Research Unit, Maroochydore
University Multiprofile Hospital for Active Treatment Dr. G. Stranski EAD, Pleven
DRC Gyogyszervizsgalo Kozpont Kft., Balatonfüred
AZ Delta, Roeselare
Centro de Investigacion y Tratamiento Reumatologico SC Consultorio Medico de Reumatologia (CINTRE), Mexico City
AAIR Research Center, Rochester
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela
Altoona Center for Clinical Research, Duncansville
East Penn Rheumatology Associates, P.C., Bethlehem
Hamburger Rheuma Forschungszentrum I, Hamburg
Center for Arthritis and Rheumatic Diseases, Chesapeake
Center for Arthritis and Rheumatic Diseases, Suffolk
Physicians East, PA, Greenville
PMG Research of Salisbury, Salisbury
Articularis Healthcare Group dba ACME Research, Orangeburg
Articularis Healthcare Group d/b/a Low Country Rheumatology, Summerville
Piedmont Arthritis Clinic, Greenville
University of Florida College of Medicine - Jacksonville - Rheumatology Research, Jacksonville
University of Florida, Rheumatology at ACC, Jacksonville
Omega Research Consultants, DeBary
Center for Arthritis and Rheumatic Diseases, Miami
AARDS Research Inc, Aventura
West Broward Rheumatology Associates, Inc., Tamarac
RASF-Clinical Research Inc, Boca Raton
USF Health Morsani Center for Advanced Healthcare, Tampa
BayCare Medical Group, Inc, Tampa
Jeffrey Alper, MD, Naples
Medallion Clinical Research Institute, LLC, Naples
Suncoast Clinical Research, Inc., New Port Richey
Florida Arthritis & Osteoporosis Center, Port Richey
Gulf Coast Medical Center, Port Richey
Morales Vargas Centro de Investigacion SC (Consultorio Anexo), León
North Mississippi Medical Clinics, Inc. - Clinical Research, Tupelo
Hospital Infanta Luisa, Seville
Group Health Associates, Cincinnati
Cincinnati Rheumatic Disease Study Group, Inc., Cincinnati
STAT Research, Inc., Dayton
Diagnostic Rheumatology and Research, PC, Indianapolis
Beacon Medical Group Rheumatology Main Street, Granger
Hospital Universitario de Cruces, Barakaldo
Western Michigan University Homer Stryker MD, Kalamazoo
Bronson Internal Medicine and Rheumatology, Battle Creek
Trinity Health Center-Medical Arts, Minot
Quincy Medical Group, Quincy
Ochsner Clinic Baton Rouge, Baton Rouge
CHI St. Vincent Medical Group Hot Springs, Hot Springs
Health Research of Oklahoma, Oklahoma City
Oklahoma Medical Research Foundation (OMRF), Oklahoma City
Lynn Health Science Institute, Oklahoma City
Metroplex Clinical Research Center, Dallas
Pioneer Research Solutions, Inc., Cypress
Institute of Arthritis Research, Idaho Falls
Arthrocare, Arthritiscare & Research, PC, Gilbert
SunValley Arthritis Center, Ltd., Peoria
Inland Rheumatology and Osteoporosis Medical Group, Upland
Inland Rheumatology Clinical Trials, Inc., Upland
Desert Valley Medical Group, Victorville
HCP Clinical Research, LLC, Huntington Beach
Robin K. Dore, MD, Inc., Tustin
Pacific Arthritis Center Medical Group, Santa Maria
Med Investigations, Inc, Fair Oaks
Sierra Rheumatology, Roseville
"Federal State Budgetary Scientific Institution Research Institute of Rheumatology", Moscow
SAHI YR Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev, Yaroslavl
"State Budgetary Institution of Healthcare of Yaroslavl Region Regional Clinical Hospital", Yaroslavl
"FSBIH Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Saint Petersburg
"SPb SBIH Consultative-Diagnostic Centre #85", Saint Petersburg
"NSHI Departmental Hospital at Smolensk station OJSC Russian Railways", Smolensk
"SBIH Samara Regional Clinical Hospital n.a. V.D. Seredavin", Samara
"FSBEI HE Orenburg State Medical University of MoH RF", Orenburg
"FSBEI HE Orenburg State Medical University of MoH RF", Orenburg
Rheumatology Associates of North Alabama, PC, Huntsville
Phase III Clinical Research, Fall River
Clinical Pharmacology Study Group, Worcester
Arthritis & Osteoporosis Associates, Freehold
Radnet, Marlton
Arthritis, Rheumatic & Back Disease Associates, P.A., Voorhees Township
Open MRI & Diagnostic Imaging of Wall, Wall
CCBR Czech Brno, s.r.o., Brno
LEKARNA LANCIER s.r.o., Brno
Lekarna Na Lidicke, Brno
Revmacentrum MUDr. Mostera, s.r.o., Revmatologie a interna, Brno
CCBR Ostrava, s.r.o., Ostrava
Lekarna Rezidence Nova Karolina, Ostrava
Revmatologicky ustav, Lekrna, Prague
Revmatologicky ustav, Prague
Lekarna Hradebni s.r.o., Uherské Hradiště
MEDICAL PLUS, s.r.o. Revmatologicka a osteologicka ambulance, Uherské Hradiště
PV - MEDICAL s.r.o., Revmatologicka ambulance, Zlín
Revmavita s.r.o, Lekarna, Zlín
Zdrowie OSTEO-MEDIC s.c. L i A. Racewicz, A i J. Supronik, Bialystok
ClinicMed Daniluk, Nowak. Sp. j., Bialystok
Nzoz Bif - Med, Bytom
Centrum Medyczne Pratia Krakow, Krakow
Malopolskie Centrum Medyczne S.C., Krakow
NZOZ Lecznica MAK-MED. S.C., Nadarzyn
MTZ Clinical Research Sp. z o.o., Warsaw
AAGS s.r.o., Dunajská Streda
MEDMAN s.r.o., Martin
REUMACENTRUM s.r.o., Partizánske
MUDr. Zuzana Cizmarikova, s.r.o., Poprad
Reumex s.r.o, Rimavská Sobota
Clinical Trial Pharmacy, KyungHee University Hospital, Seoul
KyungHee University Hospital, Seoul
CTC Pharmacy, Seoul National University Hospital, Seoul
Seoul National University Hospital, Seoul
Konkuk University Medical Center, Seoul
Clinical Trial Pharmacy, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
The Catholic University of Korea Seoul, St. Mary's Hospital, Seoul
Countess of Chester Hospital NHS Foundation Trust, Chester
Pharmacy (dispensary), Chester
Countess of Chester Hospital NHS Foundation Trust, Ellesmere Port
Hampshire Hospitals NHS Foundation Trust, Basingstoke
Pharmacy, Hampshire Hospitals NHS Foundation Trust, Basingstoke
Department of Rheumatology, Wirral University Teaching Hospital NHS Foundation Trust, Metropolitan Borough of Wirral
Pharmacy Department, Wirral University Teaching Hospital NHS Foundation Trust, Metropolitan Borough of Wirral
Wirral University Teaching Hospital NHS Foundation Trust, Metropolitan Borough of Wirral
Pharmacy Department, Dudley
The Dudley Group NHS Foundation Trust, Dudley
Pharmacy, Manchester
University Hospital of South Manchester NHS Foundation Trust, Manchester
Lead Sponsor
Pfizer
INDUSTRY