Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
OPAL BROADEN
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
2 other identifiers
interventional
422
16 countries
123
Brief Summary
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2014
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedStudy Start
First participant enrolled
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2015
CompletedResults Posted
Study results publicly available
July 6, 2017
CompletedJuly 6, 2017
June 1, 2017
1.9 years
June 12, 2013
December 4, 2016
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).
At end of Month 3
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
From Baseline to Month 3
Secondary Outcomes (38)
Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
From Baseline to Month 12
Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
At Month 12
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12
At Week 2 and Months 1, 2, 4, 6, 9, and 12
- +33 more secondary outcomes
Study Arms (5)
Tofacitinib 5 mgBID x 12 months
EXPERIMENTALTofacitinib 10 mg BID x 12 months
EXPERIMENTALAdalimumab 40 mg q2 weeks x 12 months
ACTIVE COMPARATORPlacebo x3 months, then tofacitinib 5 mg BIDx 9 months
PLACEBO COMPARATORPlacebo x 3 months, then tofacitinib 10 mg BID x 9 months
PLACEBO COMPARATORInterventions
Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
Eligibility Criteria
You may qualify if:
- Males or females, aged \>= 18 years at time of consent.
- Have a diagnosis of Psoriatic arthritis (PsA) of \>= 6 months
- Meet the Classification Criteria of PsA (CASPAR) at time of screening
- Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
- Must not have taken a biologic Tumour Necrosis Factor Inhibitor
- Must have 3 or more swollen joints AND 3 or more tender joints
- Must have active psoriasis skin lesions
You may not qualify if:
- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
- Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
- New York Heart Association Class III and IV congestive heart failure
- History of hypersensitivity or infusion reaction to biologic agents
- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (123)
Rheumatology Associates, PC
Birmingham, Alabama, 35205, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306, United States
Medvin Clinical Research
Covina, California, 91723, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Advances In Medicine (X-Rays)
Rancho Mirage, California, 92270, United States
San Diego Arthritis Medical Clinic
San Diego, California, 92108, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc.
Palm Harbor, Florida, 34684, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
St. Paul Rheumatology, PA
Eagan, Minnesota, 55121, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, 03756, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77008, United States
Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah
Salt Lake City, Utah, 84112, United States
University of Utah Hospital & Clinics
Salt Lake City, Utah, 84132, United States
Dynacare Laboratories (Specimen processing for shipment)
Seattle, Washington, 98122, United States
Investigational Drug Service Pharmacy, Swedish Medical Center.
Seattle, Washington, 98122, United States
Seattle Rheumatology Associates
Seattle, Washington, 98122, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Rheumatology Research Unit
Maroochydore, Queensland, 4558, Australia
Pacific Private Clinic
Southport, Queensland, 4215, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168, Australia
Pharmacy Clinical Trials
Clayton, Victoria, 3168, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065, Australia
Emeritus Research Pty Ltd
Malvern East, Victoria, 3145, Australia
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels, 1070, Belgium
University Hospital Leuven, Department of Rheumatology
Leuven, 3000, Belgium
UMHAT "Dr. G. Stranski" EAD
Pleven, 5800, Bulgaria
MHAT"Plovdiv" AD
Plovdiv, 4000, Bulgaria
MHAT "Kaspela" EOOD
Plovdiv, 4002, Bulgaria
UMHAT "Sv. Ivan Rilski" EAD
Sofia, 1612, Bulgaria
MC "New rehabilitation center" EOOD, Rheumatology Cabinet
Stara Zagora, 6003, Bulgaria
Rheumatology Research Associates
Edmonton, Alberta, T5M 0H4, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
West Island Rheumatology Research Associates
Pointe-Claire, Quebec, H9R 3J1, Canada
Revmacentrum MUDr. Mostera, s.r.o.
Brno, Czech Republic, 615 00, Czechia
Revmatologicky Ustav - Lekarna (pharmacy only)
Prague, Czech Republic, 128 50, Czechia
Revmatologicka ambulance
Prague, Czech Republic, 140 00, Czechia
MEDIGAP, s.r.o. (radiology only)
Praha 1 - Nove Mesto, Czech Republic, 110 00, Czechia
Lekarna Na Lidicke (Pharmacy only)
Brno, 602 00, Czechia
X-MEDICA s.r.o (radiology only)
Brno, 61300, Czechia
Revmatologie s.r.o.
Brno, 638 00, Czechia
Stavovska s.r.o. (pharmacy only)
Brno, 63800, Czechia
Vesalion s.r.o.
Ostrava, 70200, Czechia
Revmatologicky ustav - Lekarna
Prague, 128 50, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
MEDIGAP, s.r.o
Praha 1- Nove Mesto, 110 00, Czechia
Medical Plus s.r.o. Lekarna Hradebni s. r.o
UherskĂ© HradiÅ¡tÄ›, 68601, Czechia
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
Corbeil-Essonnes, 91106, France
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Rheumapraxis Steglitz
Berlin, 12161, Germany
University Hospital of Cologne
Cologne, 50937, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
Revita Reumatologiai Rendelo
Budapest, 1027, Hungary
Qualiclinic Kft.
Budapest, 1036, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly
Budapest, 1062, Hungary
Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only
Veszprém, 8200, Hungary
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
Veszprém, 8200, Hungary
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, 44160, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
CuliacĂ¡n, Sinaloa, 80000, Mexico
Laboratorios de Analisis Clinicos CEMSI
CuliacĂ¡n, Sinaloa, 80000, Mexico
Sanatorio CEMSI Chapultepec (For Emergencies Only)
CuliacĂ¡n, Sinaloa, 80040, Mexico
Hospital General de CuliacĂ¡n Dr. Bernardo J. GastĂ©lum
CuliacĂ¡n, Sinaloa, 80230, Mexico
Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)
MĂ©rida, YucatĂ¡n, 97000, Mexico
Unidad Reumatologica Las Americas, S.C.P.
MĂ©rida, YucatĂ¡n, 97000, Mexico
Centro de Investigacion Clinica Pensiones
MĂ©rida, YucatĂ¡n, 97070, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
MĂ©rida, YucatĂ¡n, 97130, Mexico
Hospital Star Medica Merida (For Emergencies Only)
MĂ©rida, YucatĂ¡n, 97133, Mexico
HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)
MĂ©rida, YucatĂ¡n, 97133, Mexico
Investigacion y Biomedicina de Chihuahua SC
Chihuahua City, 31000, Mexico
Cliditer, S. A. de C. V
Mexico City, 06700, Mexico
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"
Bialystok, 15-002, Poland
ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik
Bialystok, 15-351, Poland
ClinicMed Badurski i wspolnicy Spolka Jawna
Bialystok, 15-879, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
Bydgoszcz, 85-168, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, 82-300, Poland
Centrum Radiologii for X-Ray only
Elblag, 82-300, Poland
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag, 82-300, Poland
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
Grodzisk Mazowiecki, 05-825, Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin, 20-582, Poland
NZOZ Lecznica MAK-MED S.C.
Nadarzyn, 05-830, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
Poznan, 61-397, Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Torun, 87-100, Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, 01-868, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, 02-118, Poland
Reumatika Centrum Reumatologii
Warsaw, 02-691, Poland
Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A
Warsaw, 02-758, Poland
Synexus Polska Sp. z o.o. Oddz. we Wroclawiu
Wroclaw, 50-088, Poland
Regional State Budgetary Healthcare Institution of Karelia Republic
Petrozavodsk, Karelia Republic, 185019, Russia
State Budgetary Institution of Healthcare of Moscow City Clinical Hospital
Moscow, 119049, Russia
OOO City Neurological Centre "Sibneiromed"
Novosibirsk, 630091, Russia
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
Novosibirsk, 630099, Russia
State Institution of Healthcare "Regional Clinical Hospital"
Saratov, 410053, Russia
State Budget Educational Institution of Highest Professional Education
Tomsk, 634050, Russia
State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, 150003, Russia
State Institution of Healthcare of Yaroslavl Region
Yaroslavl, 150003, Russia
ROMJAN s.r.o., Reumatologicka ambulancia
Bratislava, Slovak Republic, 832 63, Slovakia
MEDMAN s.r.o. - reumatologicka ambulancia
Martin, Slovak Republic, 036 01, Slovakia
Nestatna reumatologicka ambulancia
Bratislava, 841 04, Slovakia
Reumex s.r.o
RimavskĂ¡ Sobota, 979 01, Slovakia
Hospital Clinico de Santiago
Santiago de Compostela, A Coruna, 15706, Spain
CorporaciĂ³ Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Infanta Luisa
Seville, 41010, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Taipei Veterans General Hospital
Taipei, Taiwan Roc, 11217, Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 62247, Taiwan
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
Goodmayes, Essex, IG3 8YB, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, Essex, RM7 0AG, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, DY1 2HQ, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, BD5 0NA, United Kingdom
Bradford Royal Infirmary, BTHFT
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Upton, Wirral, CH49 5PE, United Kingdom
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE, United Kingdom
Related Publications (29)
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 Dec;12(6):1175-1186. doi: 10.1007/s40744-025-00800-7. Epub 2025 Oct 28.
PMID: 41148555DERIVEDGladman 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.
PMID: 40241921DERIVEDGladman 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.
PMID: 39702318DERIVEDMease PJ, Orbai AM, FitzGerald O, Bedaiwi M, Dona L Fleishaker, Mundayat R, Young P, Helliwell PS. Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: analysis of pooled data from two phase 3 studies. Arthritis Res Ther. 2023 Aug 22;25(1):153. doi: 10.1186/s13075-023-03108-5.
PMID: 37608391DERIVEDEder 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.
PMID: 36958766DERIVEDKristensen 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.
PMID: 36931693DERIVEDDougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478.
PMID: 36814062DERIVEDWinthrop 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.
PMID: 36526796DERIVEDSchneeberger EE, Citera G, Nash P, Smolen JS, Mease PJ, Soriano ER, Helling C, Szumski AE, Mundayat R, de Leon DP. Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies. Semin Arthritis Rheum. 2023 Feb;58:152134. doi: 10.1016/j.semarthrit.2022.152134. Epub 2022 Nov 13.
PMID: 36476498DERIVEDde Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.
PMID: 36076054DERIVEDOrbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.
PMID: 36045453DERIVEDTaylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.
PMID: 35385361DERIVEDGladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.
PMID: 35139908DERIVEDDikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
PMID: 34921355DERIVEDWinthrop 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.
PMID: 34870800DERIVEDKivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.
PMID: 34510295DERIVEDde Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609.
PMID: 34226183DERIVEDCoates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.
PMID: 33766074DERIVEDRitchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.
PMID: 32910531DERIVEDPanaccione 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.
PMID: 32816215DERIVEDBurmester 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.
PMID: 32006348DERIVEDGladman 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.
PMID: 31112005DERIVEDCella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.
PMID: 31111255DERIVEDvan der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.
PMID: 30824647DERIVEDStrand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.
PMID: 30713721DERIVEDCella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5.
PMID: 30680661DERIVEDNash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.
PMID: 30414064DERIVEDHelliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.
PMID: 30373651DERIVEDMease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.
PMID: 29045212DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 14, 2013
Study Start
January 20, 2014
Primary Completion
December 18, 2015
Study Completion
December 18, 2015
Last Updated
July 6, 2017
Results First Posted
July 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests