Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
NCT ID: NCT01976364
Last Updated: 2020-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
686 participants
INTERVENTIONAL
2014-02-17
2019-05-20
Brief Summary
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This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tofacitinib
Tofacitinib
Tofacitinib 5 mg tablet twice daily
Tofacitinib
Tofactinib 10 mg tablet twice daily
Methotrexate
Methotrexate 7.5-20 mg weekly
Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Interventions
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Tofacitinib
Tofacitinib 5 mg tablet twice daily
Tofacitinib
Tofactinib 10 mg tablet twice daily
Methotrexate
Methotrexate 7.5-20 mg weekly
Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
* Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)
Exclusion Criteria
* Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.
-Subjects who are receiving methotrexate by a route other than oral
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Rheumatology Associates, PC
Birmingham, Alabama, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States
Desert Medical Advances
Palm Desert, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Stanford Anatomic Pathology and Clinical Lab
Stanford, California, United States
Stanford Health Care Department of Pharmacy lnvestigational Drug Services
Stanford, California, United States
Stanford University Hospitals and Clinics
Stanford, California, United States
New England Research Associates, LLC
Bridgeport, Connecticut, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Arthritis Center, Inc.
Palm Harbour, Florida, United States
Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
St. Luke's Clinic - Rheumatology
Boise, Idaho, United States
St. Luke's Intermountain Research Center
Boise, Idaho, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States
Klein and Associates, M.D., P.A.
Hagerstown, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Clayton Medical Research
St Louis, Missouri, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
Summerville, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, United States
Investigational Drug Services
Salt Lake City, Utah, United States
University of Utah Hospital & Clinics
Salt Lake City, Utah, United States
University of Utah Hospitals and Clinics - Clinie 2
Salt Lake City, Utah, United States
Swedish Medical Center
Seattle, Washington, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Rheumatology Research Unit
Maroochydore, Queensland, Australia
Pacific Private Clinic
Southport, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels, Brabant Flamand, Belgium
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels, , Belgium
Reumaclinic
Genk, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
University Hospital Leuven
Leuven, , Belgium
ZNA Jan Palfijn
Merksem, , Belgium
CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
Juiz de Fora, Minas Gerais, Brazil
EDUMED - Educação em Saùde SS Ltda
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
UMHAT "Dr. G. Stranski" EAD, Department of Rheumatology
Pleven, , Bulgaria
Multiprofile Hospital for Active Treatment - Plovdiv AD
Plovdiv, , Bulgaria
Multiprofile hospital for active treatment Kaspela EOOD
Plovdiv, , Bulgaria
Medical Center - "New rehabilitation center" EOOD
Stara Zagora, , Bulgaria
K. Papp Clinical Research
Waterloo, Ontario, Canada
X-Medica, s.r.o.
Brno, , Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno, , Czechia
Stavovska, s.r.o.
Brno, , Czechia
Revmatologie s.r.o.
Brno, , Czechia
Vesalion s.r.o.
Ostrava, , Czechia
Revmatologicky ustav - Lekarna
Prague, , Czechia
Revmatologicky ustav
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, Mecklenburg-vorp, Germany
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Rheumapraxis Steglitz
Berlin, , Germany
Schlosspark-Klinik
Berlin, , Germany
University Hospital of Cologne
Cologne, , Germany
CIRI, Centrum fuer innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH)
Frankfurt am Main, , Germany
Medizinische Universitaetsklinik Freiburg
Freiburg im Breisgau, , Germany
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, , Germany
Elisabeth Klinik Bigge
Olsberg, , Germany
Diagnoscan Magyarország Kft.
Budapest, , Hungary
Budapest Fovaros II. keruleti Onkormanyzat Egeszsegugyi Szolgalata- Rontgen- Ultrahang
Budapest, , Hungary
Revita Reumatologiai Rendelo
Budapest, , Hungary
Qualiclinic Kft.
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont - Kozponti Radiologiai Diagnosztika Osztaly
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont, Reumatologiai Osztaly
Budapest, , Hungary
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
Veszprém, , Hungary
Csolnoky Ferenc Korhaz
Veszprém, , Hungary
Hospital Angeles Clinica Londres
Mexico City, D.F, Mexico
Centro Integral en Reumatologia S.A. de C.V.
Guadalajara, Jalisco, Mexico
Grupo Medico Camino S.C.
Mexico City, Mexico City, Mexico
Cliditer, S.A. DE C.V.
Mexico City, Mexico City, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
Culiacán, Sinaloa, Mexico
Sanatorio CEMSI Chapultepec
Culiacán, Sinaloa, Mexico
Hospital General de Culiacan Dr. Bernardo J. Gastelum
Culiacán, Sinaloa, Mexico
Instituto Medico Panamericano, S.A de C.V.
Mérida, Yucatán, Mexico
Unidad Reumatologica Las Americas S.C.P.
Mérida, Yucatán, Mexico
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion Clinica En
Mérida, Yucatán, Mexico
Christus Muguerza del Parque S.A. de C.V.
Chihuahua City, , Mexico
Investigacion y Biomedicina de Chihuahua SC
Chihuahua City, , Mexico
Centrum Medyczne Pratia S.A. Warszawa
Warsaw, Masovian Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.
Bialystok, , Poland
Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
Bialystok, , Poland
ClinicMed Daniluk, Nowak Spolka Jawna
Bialystok, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
Elblag, , Poland
Centrum Radiologii
Elblag, , Poland
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag, , Poland
Wojewodzki Szpital Zespolony, Zaklad Radiologii
Elblag, , Poland
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
Grodzisk Mazowiecki, , Poland
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
Lodz, , Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin, , Poland
Top-Medical Sp. z o. o.
Lublin, , Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, , Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, , Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Torun, , Poland
Rheuma-Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Reumatika Centrum Reumatologii NZOZ
Warsaw, , Poland
Synexus Polska Oddzial we Wroclawiu
Wroclaw, , Poland
State Autonomic Healthcare Institution ''City Clinical Hospital # 7''
Kazan', Tatarstan Republic, Russia
SBIH of Moscow "City Clinical Hospital #1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
Moscow, , Russia
Research Institution of Fundamental and Clinical Immunology
Novosibirsk, , Russia
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
Novosibirsk, , Russia
Regional State Budgetary Health Care Institution of Karelia Republic
Petrozavodsk, , Russia
State Institution of Healthcare Regional Clinical Hospital
Saratov, , Russia
State Budget Educational Institution of Highest Professional Education
Tomsk, , Russia
State Autonomous Healthcare lnstitution of Yaroslavl Region "Clinical Hospital of Emergency Medical
Yaroslavl, , Russia
State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a.N.V. Solovyev
Yaroslavl, , Russia
Nestatna reumatologicka ambulancia
Bratislava, , Slovakia
MEDMAN s.r.o. - reumatologicka ambulancia
Martin, , Slovakia
REUMEX, s.r.o
Rimavská Sobota, , Slovakia
Hospital Clinico de Santiago
Santiago de Compostela, A Coruna, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Quiron Salud Infanta Luisa
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, , Taiwan
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
Goodmayes, Essex, United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust
Romford, Essex, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, WEST Midlands, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, WEST Yorkshire, United Kingdom
Bradford Royal lnfirmary, BTHFT
Bradford, WEST Yorkshire, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Upton, Wirral, United Kingdom
Royal United Hospitals NHS Foundation Trust
Bath, , United Kingdom
York Teaching Hospital NHS Foundation Trust
York, , United Kingdom
Countries
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References
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Gossec L, Sellas A, Gruben DC, Valderrama M, Gomez S, Kinch C, Citera G. Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials. Rheumatol Ther. 2025 Oct 28. doi: 10.1007/s40744-025-00800-7. Online ahead of print.
Gladman DD, Dougados M, Marzo-Ortega H, Cadatal MJ, Agarwal E, Kinch CD, Nash P. Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis. Rheumatol Adv Pract. 2025 Jan 21;9(2):rkaf008. doi: 10.1093/rap/rkaf008. eCollection 2025.
Gladman DD, Nash P, Mease PJ, FitzGerald O, Duench S, Cadatal MJ, Masri KR. Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis. Arthritis Res Ther. 2024 Dec 19;26(1):218. doi: 10.1186/s13075-024-03442-2.
Nash P, Coates LC, Fleishaker D, Kivitz AJ, Mease PJ, Gladman DD, FitzGerald O, Wang C, Wu J, Hsu MA, Menon S, Fallon L, Kanik KS. Safety and efficacy of tofacitinib up to 48 months in patients with active psoriatic arthritis: final analysis of the OPAL Balance long-term extension study. Lancet Rheumatol. 2021 Apr;3(4):e270-e283. doi: 10.1016/S2665-9913(21)00010-2. Epub 2021 Mar 24.
Nash P, Mease PJ, Fleishaker D, Wu J, Coates LC, Behrens F, Gladman DD, Kivitz AJ, Wei JC, Shirinsky I, Menon S, Romero AB, Fallon L, Hsu MA, Wang C, Kanik KS. Tofacitinib as monotherapy following methotrexate withdrawal in patients with psoriatic arthritis previously treated with open-label tofacitinib plus methotrexate: a randomised, placebo-controlled substudy of OPAL Balance. Lancet Rheumatol. 2021 Jan;3(1):e28-e39. doi: 10.1016/S2665-9913(20)30339-8. Epub 2020 Nov 16.
Eder L, Gladman DD, Mease P, Pollock RA, Luna R, Aydin SZ, Ogdie A, Polachek A, Gruben D, Cadatal MJ, Kinch C, Strand V. Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension. RMD Open. 2023 Mar;9(1):e002718. doi: 10.1136/rmdopen-2022-002718.
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.
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.
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.
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.
Nash P, Coates LC, Kivitz AJ, Mease PJ, Gladman DD, Covarrubias-Cobos JA, FitzGerald O, Fleishaker D, Wang C, Wu J, Hsu MA, Menon S, Fallon L, Romero AB, Kanik KS. Safety and Efficacy of Tofacitinib in Patients with Active Psoriatic Arthritis: Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study. Rheumatol Ther. 2020 Sep;7(3):553-580. doi: 10.1007/s40744-020-00209-4. Epub 2020 Jun 6.
Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.
Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-002169-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OPAL BALANCE
Identifier Type: OTHER
Identifier Source: secondary_id
A3921092
Identifier Type: -
Identifier Source: org_study_id
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