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

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP-690,550

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring long-term, open-label, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

University of Alabama at Birmingham
Rheumatology Associates of North Alabama, PC
Arthrocare, Arthritis Care & Research, PC
Arizona Arthritis & Rheumatology Associates, P.C.
Radiant Research, Inc.
Catalina Pointe Clinical Research
CHI St. Vincent Medical Group Hot Springs
NEA Baptist Clinic
Osborne Research Center, LLC
Little Rock Diagnostic Clinic, PA
Med Investigations, Inc.
Talbert Medical Group
University of California San Diego Center for Innovative Therapy
Keck Medicine of USC
University of Southern California (USC) Norris Comprehensive Cancer Center-
University of Southern California (USC) Norris Comprehensive Cancer Center
Ronald Reagan UCLA Medical Center, Drug Information Center
University of California Los Angeles
Stanford University School of Medicine
Office of Anupama Bhat, MD
San Diego Arthritis Medical Clinic
Pacific Arthritis Center Medical Group
Stanford Health Services - Medical Specialty Clinics
Inland Rheumatology Clinical Trials, Inc.
Boulder Medical Center, PC
Arthritis Associates and Osteoporosis Center of Colorado Springs
University of Connecticut Health Center
Arthritis & Osteoporosis Center, PC
New England Research Associates, LLC
Delaware Arthritis and Osteoporosis Center
Arthritis and Rheumatic Disease Specialties
Allergy, Asthma, Arthritis, & Lung
Physicians Research Alliance LLC
Southeastern Arthritis Center
Southeastern Imaging and Diagnostics
Southeastern Integrated Medical PL d/b/a Florida Medical Research Institute
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Jacksonville Center for Clinical Research
Florida Arthritis Center, P.L.
BayCare Outpatient Imaging at Bardmoor
Center for Arthritis and Rheumatic Diseases
Jeffrey Alper MD Research
Suncoast Clinical Research, Inc.
Ocala Rheumatology Research Center
Dr. Jeffrey E. Poiley, MD , Office of
Millennium Research
DMI Research, Inc.
Florida Arthritis & Osteoporosis Center
Gulf Coast Medical Center
Suncoast Medical Clinic
Arthritis & Rheumatic Care Center
Miami Research Associates
West Broward Rheumatology Associates, Inc.
BayCare Medical Group, Inc
Lovelace Scientific Resources
Venice Arthritis Center
Florida Medical Clinic, P.A.
Arthritis and Rheumatology of Georgia P.C.
Jeffrey D. Lieberman, MD, PC
Marietta Rheumatology Associates
St. Luke's Clinic - Rheumatology
St. Luke's Clinic
St. Luke's Intermountain Research Center
Institute of Arthritis Research
St. Luke's Clinic - Rhematology
Loyola University Medical Center
Illinois Bone and Joint Institute, LLC
Rockford Health Physicians
Rockford Orthopedic Associates
Springfield Clinic
Springfield Clinic - Clinical Research
Deerbrook Medical Associates
Diagnostic Rheumatology And Research PC
Physician's Clinic of Iowa, P.C.
Medical Associates Clinic, PC
Kansas City Internal Medicine
Professional Research Network of Kansas, LLC
Via Christi Clinic, P.A.
Bluegrass Community Research, Inc.
Ochsner Clinic Foundation - Baton Rouge
Louisiana State University Health Sciences Center
Rheumatology Associates
Klein and Associates, MD, PA
The Arthritis Treatment Center
The Center for Rheumatology and Bone Research
Clinical Research Center of Cape Cod, Inc.
Reliant Medical Group, Inc.
Reliant Medical Group, Inc. at Worcester Medical Center
Bronson Internal Medicine and Rheumatology
QUEST Research Institiute
Borgess Research Institute
Farmbrook Radiology Associates
Arthritis and Rheumatology Consultants, P.A.
North Mississippi Medical Clinics, Inc.
University Physicians - Woodrail Clinic
University Of Missouri-Columbia
Physician Research Collaboration, LLC
Clinical Pharmacology Study Group
Westroads Clinical Research, Inc.
Heartland Clinic Research, Inc.
Dartmouth-Hitchcock Medical Center
Rheumatology Associates of North Jersey
Arthritis, Rheumatic & Back Disease Associates
The Center for Rheumatology, LLP
Regional Rheumatology Associates
Southern Tier Arthritis and Rheumatism
Buffalo Rheumatology and Medicine, PLLC
AAIR Research Center
Asheville Rheumatology & Osteoporosis Research Associates, P.A.
Asheville Rheumatology & Osteoporosis Research Associates, PA
DJL Clinical Research, PLLC
PMG Research Hickory, LLC
PMG Research of Hickory
Boice-Willis Clinic
Trinity Health Center - Medical Arts
Cincinnati Rheumatic Disease Study Group, Inc.
STAT Research, Inc.
Office of David R. Mandel, MD, Inc.
Oklahoma Medical Research Foundation (OMRF)
Lynn Health Science Institute
East Penn Rheumatology Associates, PC
Altoona Center for Clinical Research
Rheumatic Disease Associates, Ltd.
Clinical Research Center of Reading LLP
Piedmont Arthritis Clinic, PA
Arthritis Associates, PLLC
Arthritis Clinic
West Tennessee Research Institute
Rheumatology Consultants, PLLC
Vanderbilt University Medical Center
Office of John P. Lavery, MD, PA
Austin Rheumatology Research, PA
Arthritis Care and Diagnostic Center, P.A.
Baylor Research Institute
Metroplex Clinical Research Center
University of North Texas Health Science Center at Fort Worth
Accurate Clinical Research, Inc.
Houston Institute for Clinical Research
Arthritis and Osteoporosis Associates, LLP
Southwest Rheumatology Research, LLC
Virginia Mason Medical Center
Seattle Rheumatology Associates
The Seattle Arthritis Clinic
Tacoma Center of Arthritis Research, PS
The Vancouver Clinic, Inc. PS
Mountain State Clinical Research
Gundersen Clinic, Ltd
OMI- Organizacion Medica de Investigacion
Centro de Investigaciones Reumatologicas y Osteologicas -CIRO
Hospital Sirio Libanes
OMI - Organización Médica de Investigación
Saint Dennis Medical Group S.A.
Hospital Sirio Libanes
Consultorios Reumatologicos Pampa
Optimus Clinical Research Pty. Ltd.
Rheumatology Research
Rheumatology Research Unit Sunshine Coast
Queen Elizabeth Hospital, Department of Rheumatology
Emeritus Research
Goatcher Clinical Research Unit
Royal North Shore Hospital
Medizinische Universitaet Wien / AKH
Rheuma-Ordination Favoriten
Sozialmedizinisches Zentrum Sued - Kaiser Franz Josef Spital
Universitair Ziekenhuis Gent - Reumatologie
AZ Groeninge
Centre Hospitalier Universitaire de Liège
University Clinical Center Sarajevo
CIP - Centro Internacional de Pesquisa
Centro de Estudos em Terapias Inovadoras
Centro de Estudos em Terapias Inovadoras
CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
Hospital de Clinicas de Porto Alegre
Hospital Sao Lucas da PUCRS
Hospital Alemao Oswaldo Cruz
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
IMA Brasil -Instituto de Pesquisa Clinica e Medicina Avancada
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
Revmatologichen kabinet, DKTs Sveti Pantaleimon OOD
Revmatologichno Otdelenie, MBAL - Plovdiv
UMBAL Kaspela Plovdiv
MBAL Akta Medika OOD
Clinic of Cardiology and Rheumatology Military Medical Academy
Clinic of Rheumatology Multiprofile Hospital for Active treatment Sveti Ivan Rilski
MBAL Sveti Ivan Rilski Sofia
DKTs "Sveta Anna" Sofia, Konsultativen kabinet po Revmatologia
DKTs "Sveta Anna", Sofia / Diagnostic Consultative Center "Sveta Anna"
MOBAL "D-r Stefan Cherkezov" AD,
Rheumatology Research Associates Ltd.
Dr. Alice Klinkhoff, Inc.
Percuro Clinical Research Limited
Manitoba Clinic
Nexus Clinical Research
Dr. William G. Bensen Medicine Professional Corporation
Office of Dr. Fernando Bianchi
Cividino Medicine Professional Corporation
KW Musculoskeletal Research Inc.
St Joseph's Health Centre
Credit Valley Rheumatology
The Arthritis Program Research Group Inc.
Rheumatology and Osteoporosis Clinic
Rheumatology Research Associates
Niagara Peninsula Arthritis Centre
Clinical Research and Arthritis Centre
Institut de Rhumatologie de Montreal
West Island Rheumatology Research Associates
Centre de Recherche Musculo-Squelettique
Arthritis Research Center, Royal University Hospital
Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
Centre de Recherche Saint-Louis
Consulta Privada Dra. Lucia Ponce
Centro de Diagnostico y Tratamiento Hospital San Borja Arriaran
Hospital Base Valdivia, Policlinico de Reumatologia
Centro de Estudios Reumatologicos
Consulta Privada Dra. Marta Aliste
Clinica Santa Maria, Seccion Reumatologia
Hospital Regional de Rancagua
Clinica Santa Maria
Estudios Clinicos V Region
Beijing Chaoyang Hospital, Capital University of Medical Science
The Second Affiliated Hospital of Guangzhou Medical University
The Third Affiliated Hospital of Sun Yat-Sen University
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Xiangya Hospital of Centre-south University
Xijing Hospital, The Fourth Military Medical University
QiLu Hospital of Shandong University
Qingdao Municipal Hospital
Shanghai Changzheng Hospital
Peking University People's Hospital/Rheumatology and Immunology Department
PLA General Hospital
Si Chuan Huaxi Hospital
The Second Affiliated Hospital of Zhejiang University School of Medicine
Anhui Province Hospital
An Hui Medical University 1st Hospital
Jiangsu Province Hospital
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai Changhai Hospital
The First Affiliated Hospital of Soochow University
"Department of Infectious Diseases & Immunology
Centro de Reumatologia y Ortopedia S.A.S.
Riesgo de Fractura S.A.
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S CIREEM S.A.S
Servimed S.A.S.
Centro de Reumatologia y Osteoporosis, Cartago
Hospital Cima San Jose
Hospital Cima San Jose
Oficina Privada Del Colegio deMedicos
University Hospital Center Osijek
University Hospital Split, Department for Internal Medicine, Division of Clinical Rheumatology
Clinical Hospital "Sveti Duh"
University Hospital Center "Zagreb"
University Hospital Center Zagreb
X-MEDICA s.r.o.
Revmacentrum MUDr. Mostera, s.r.o.
Fakultni Nemocnice Brno, Interni hematoonkologicka klinika
Fakultni nemocnice u sv. Anny v Brne
HESTE s.r.o. Revmatologie
MEDIPONT Plus sro
L.K.N. Arthrocentrum, s.r.o.
ARTMEDI UPD s r.o
Fakultni nemocnice Hradec Kralove
Revmatologicka ambulance
ARTHROMED, s. r. o. Revmatologicka ambulance
Affidea Praha, s.r.o.
Revmatologicky ustav
Revmatologicka ambulance
Fakultni Thomayerova nemocnice s poliklinikou
Nuselska poliklinika RTG
Revmatologicka ambulance
Nemocnice Atlas, a.s.
PV-Medical s.r.o.
Frederiksberg Hospital
Hospital Central de las Fuerzas Armadas
Helsingin Reumakeskus Oy
Kiljavan Laaketutkimus Oy
TAYS/Reumakeskus/Finn-Medi 1
Hopital Nord
Hôpital Nord
*CHR Hopital Porte Madeleine IPROS
CHR ORLEANS - Service IPROS
Hôpital Saint-Antoine
Hopital Cochin
Privat-Praxis
Charite Campus Mitte, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Schlosspark-Klinik Innere Medizin II, Rheumatologie
Ambulantes Rheumazentrum Dr Soerensen
Krankenhaus Friedrichstadt, I. Medizinische Klinik
Studienambulanz Universitaetsklinikum Erlangen Medizinische Klinik 3
J.W.-Goethe-Universitaetsklinik, Medizinische Klinik II, Abteilung fuer Rheumatologie
Schwerpunktpraxis Rheumatologie
Schoen Klinik Hamburg-Eilbek
Rheumazentrum Ruhrgebiet
Universitaetsklinikum Koeln Klinik I fuer Innere Medizin, Haus 16, 1. OG, Raum 1.008
Universitaetsklinik Leipzig, Klinik fur Gastroenterologie und Rheumatologie, Sektion Rheumatologie
Universitaetsklinikum Leipzig
Klinikum der Universitaet Muenchen, Campus Innenstadt, Rheuma-Einheit
Arztpraxis, Internist - Rheumatologie
Rheumaforschung- Studienambulanz
Schwerpunktpraxis fuer Rheumatologie
Universitaetsklinikum Wuerzburg
General Hospital Euromedica "KYANOUS STAVROS"
424 General Army Hospital
Drug Research Center Kft
Orszagos Reumatologiai Es Fizioterapias Intezet
Revita Reumatologiai Rendelo
Synexus Magyarorszag Kft.
MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles
Mahavir Hospital & Research Center
Rheumatic Diseases Clinic
Shalby Hospitals
Chanre Rheumatology and Immunology Center and Research
St. John's Medical College and Hospital.
Shirdi Sai Hospital
Chanre Rheumatology & Immunology Center & Research
Arthritis Research and Care Foundation Centre for Rheumatic Diseases
Jehangir Clinical Development Centre Pvt. Ltd.
Krishna Institute of Medical Sciences Ltd
St. Vincent's University Hospital
A.O.U. Careggi - SOD Medicina Interna 1 e Reumatologia
U.O. Clinica Reumatologica
Inha University Hospital
Eulji University Hospital
Dong-A University Hospital
Daegu Catholic University Medical Center
Chonnam National University Hospital
Gangnam Severance Hospital
Seoul National University Hospital
Yonsei University Health System
Hanyang University Hospital
Konkuk University Medical Center
Asan Medical Center-University of Ulsan College of Medicine
Asan Medical Center
Gangnam Severance Hospital-Yonsei University Health System
Seoul St. Mary's Hospital-The Catholic University of Korea
Hospital Tuanku Ja'afar
Queen Elizabeth Hospital
Sarawak General Hospital
Hospital Selayang
Sunway Medical Centre
Subang Jaya Medical Centre
Hospital Putrajaya, Dept. of Medicine
Centro de Investigacion del Noroeste
Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
Hospital Angeles del Pedregal
Centro Medico Toluca
Centro Integral en Reumatologia, SA de CV
Unidad de Investigacion en Enfermedades Cronico Degenerativas
Centro de Investigacion Clinica Especializada, SC
Centro de Investigacion Clinica de Morelia
Clinica de Enfermedades Cronicas y Procedimientos Especiales SC
Fundacion El Hospitalito
Hospital Universitario Doctor Jose Eleuterio Gonzalez
Unidad Reumatologica Las Americas SCP
Investigacion y Biomedica de Chihuahua, SC
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Hospital Angeles Mocel
Centro Reumatologico Queretaro
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Reumatologia y Osteoporosis
The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
Waikato Hospital, Rheumatology
Clinical Trials Unit, Timaru Hospital
Hospital Nacional IV Alberto Sabogal Sologuren
Centro Medico Corpac/Investigaciones en Reumatologia
Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
Mary Mediatrix Medical Center
De La Salle University Health Sciences Campus Clinical Epidemiology Unit
Angeles University Foundation Medical Center
Chong Hua Hospital
Southern Philippine Medical Center
University of Perpetual Help Rizal Dalta Medical Center
University of Santo Tomas Hospital
"ZDROWIE OSTEO-MEDIC" s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
ClinicMed Badurski i wspolnicy Spolka Jawna
NSZOZ Medicus II
Szpital im. Teodora Dunina
Krakowskie Centrum Medyczne NZOZ
Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski
Wojewodzki Zespol Reumatologiczny im. dr Jadwigi Titz-Kosko
Nzoz "Nasz Lekarz"
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Rheuma-Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
SYNEXUS Polska Sp. z.o.o.
Ponce School Of Medicine
Edificio Parra
Mindful Medical Research
Spitalul Clinic "Sf. Maria"
Spitalul Clinic De Recuperare
City Clinical Hospital # 1
"Consultative Diagnostic Rheumatology Center ""Healthy Joints"", LLC"
State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
Smolensk State Medical Academy
State Healthcare Institution Regional Clinical Hospital
State Healthcare Institution
State Educational Institution of Higher Professional Education Ural State Medical Academy of Federal
State Educational Institution of Higher Professional Education
Ltd.Medical Association "Novaya Bolnitsa"
State Healthcare Institution Regional Clinical Hospital for War Veterans
Russian State Medical University Moscow Faculty City Clinical Hospital #4
Rheumatology Research Institute of Russian Academy of Medical Sciences
GUZ Republican Hospital n.a. Baranov
Federal North-West Medical Research Centre
Saint-Petersburg State Budgetary Healthcare Institution "Clinical Rheumathology Hospital #25"
Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
Regional State Budget Institution Of Healthcare
Regional State Budgetary Healthcare Institution of Tomsk Regional Clinical Hospital
Reumatologicka ambulancia, Poliklinika Ruzinov
NOVAPHARM s.r.o -Zeleznicna NaP, Reumatologicka ambulancia
AAGS, s.r.o. , nestatne zdravotnicke zariadenie
Interna a reumatologicka ambulancia
Ecclesia, s.r.o Reumatologicka ambulancia
Narodny Ustav Reumatickych Chorob
Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
Reumatologicka ambulancia, REUMEX, s.r.o.
Reumatologicka ambulancia, Nestatne zdravotnicke zariadenie
Nestatna reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.
Hospital Nuestra Senora de la Esperanza
Hospital Clinico Universitario de Santiago
Hospital de Merida
Hospital Universitario Marques de Valdecilla
Hospital Universitario Cruces
Hospital de Basurto
Hospital Del Mar
Complejo Hospitalario Universitario A Coruna
Hospital Universitario 12 de Octubre
Hospital Universitario De La Paz
Hospital Civil. Hospital Regional Universitario Carlos Haya
Hospital Universitario Virgen Macarena
Hospital Nuestra Señora de Valme
Hospital El Tomillar
Hospital Universitari i Politecnic La Fe de Valencia
Falu lasarett
Lanssjukhuset Ryhov
Skanes Universitetssjukhus i Malmo Reumamottagningen
Sundsvalls Sjukhus
Norrlands Universitetssjukhus
Akademiska University Hospital
Chang Gung Medical Foundation-
Chang Gung Medical Foundation-Linkou Branch
Changhua Christian Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital
Taichung Veterans General Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital
Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,
Division of Allergy-Immunology-Rheumatology, Department of Medicine, Faculty of Medicine
Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
Siriraj Hospital, Mahidol University
Ege University Medical Faculty
Hacettepe University Medical Faculty
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi
Crimean Republican Institution "Clinical Territorial Medical Association "University Clinic",
Municipal Establishment of Health Care "Kharkiv City Clinical Hospital #8", Dept. of Rheumatology
State Institution Republican Clinical Hospital of the Ministry of Health of Ukraine
State Establishment "Institute of Gerontology of NAMS of Ukraine n.a. D.F. Chebotareva"
Municipal City Clinical Hospital #4, Policlinic Care
"Multifield Medical Center of Odesa National Medical University ""University Clinic #1"""
Multifield Medical Center of Odesa National Medical University "University Clinic #1"
CRIMEAN Republican Institution, "Clinical Hospital n.a. M.O. Semashko"
Vinnitsa Regional Clinical Hospital n.a. Pirogov
Municipal Establishment "City Hospital#7of Zaporizhzhia State Medical University
Dudley Group of Hospitals NHS Trust
The Royal Wolverhampton NHS Trust
Royal Victoria Infirmary
Wirral University Teaching Hospital NHS Foundation Trust-Arrowe Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Open-Label Active Treatment Enrolled from Phase 2

Open-Label Active Treatment Enrolled from Phase 3

Arm Description

Patients enrolling from Phase 2 studies

Patients enrolling from Phase 3 studies

Outcomes

Primary Outcome Measures

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

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.

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).

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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

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.

Full Information

NCT ID

NCT00413699

First Posted

December 18, 2006

Last Updated

October 1, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00413699

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 5, 2007 (Actual)

Primary Completion Date

November 30, 2016 (Actual)

Study Completion Date

October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

long-term, open-label, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4488 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open-Label Active Treatment Enrolled from Phase 2

Arm Type

Experimental

Arm Description

Patients enrolling from Phase 2 studies

Arm Title

Open-Label Active Treatment Enrolled from Phase 3

Arm Type

Experimental

Arm Description

Patients enrolling from Phase 3 studies

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

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.

Primary Outcome Measure Information:

Title

Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports

Description

Time Frame

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

Title

Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)

Description

Time Frame

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

Title

Extension Period: Number of Participants With Laboratory Test Abnormalities

Description

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

Time Frame

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 Outcome Measure Information:

Title

Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses

Description

Time Frame

Every visit until study completion

Title

Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses

Description

Time Frame

Month 3, 6, 9 and 12 of Extension Period

Title

Initial Period: Area Under American College of Rheumatology (ACR) n Curve

Description

No data were collected for this endpoint because it was removed from the protocol in a previous amendment.

Time Frame

Not applicable as no data were collected for this endpoint.

Title

Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])

Description

Time Frame

Every visit until study completion

Title

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

Description

Time Frame

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

Title

Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2

Description

Time Frame

Every visit until study completion

Title

Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2

Description

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.

Time Frame

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

Title

Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

Description

Time Frame

Every visit until study completion

Title

Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12

Description

Time Frame

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

Title

Initial Period: Short-Form-36 Health Survey (SF-36) Score

Description

Time Frame

Every visit until study completion

Title

Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)

Description

Time Frame

Every visit until study completion

Title

Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study

Description

Time Frame

Every 6 months until study completion

Title

Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations

Description

Time Frame