Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
NCT ID: NCT01877668
Last Updated: 2017-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
422 participants
INTERVENTIONAL
2014-01-20
2015-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tofacitinib 5 mgBID x 12 months
Tofacitinib 5 mg BID
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 10 mg BID x 12 months
Tofacitinib 10 mg BID
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Adalimumab 40 mg q2 weeks x 12 months
Adalimumab
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
Placebo
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
Placebo x 3 months, then tofacitinib 10 mg BID x 9 months
Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
Interventions
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Tofacitinib 5 mg BID
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 10 mg BID
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Adalimumab
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Placebo
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
Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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
Medvin Clinical Research
Covina, California, United States
Desert Medical Advances
Palm Desert, California, United States
Advances In Medicine (X-Rays)
Rancho Mirage, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Millennium Research
Ormond Beach, Florida, United States
Arthritis Center, Inc.
Palm Harbor, Florida, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Paul Rheumatology, PA
Eagan, Minnesota, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah
Salt Lake City, Utah, United States
University of Utah Hospital & Clinics
Salt Lake City, Utah, United States
Dynacare Laboratories (Specimen processing for shipment)
Seattle, Washington, United States
Investigational Drug Service Pharmacy, Swedish Medical Center.
Seattle, Washington, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Rheumatology Research Unit
Maroochydore, Queensland, Australia
Pacific Private Clinic
Southport, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Pharmacy Clinical Trials
Clayton, Victoria, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Emeritus Research Pty Ltd
Malvern East, Victoria, Australia
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels, , Belgium
University Hospital Leuven, Department of Rheumatology
Leuven, , Belgium
UMHAT "Dr. G. Stranski" EAD
Pleven, , Bulgaria
MHAT"Plovdiv" AD
Plovdiv, , Bulgaria
MHAT "Kaspela" EOOD
Plovdiv, , Bulgaria
UMHAT "Sv. Ivan Rilski" EAD
Sofia, , Bulgaria
MC "New rehabilitation center" EOOD, Rheumatology Cabinet
Stara Zagora, , Bulgaria
Rheumatology Research Associates
Edmonton, Alberta, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
West Island Rheumatology Research Associates
Pointe-Claire, Quebec, Canada
Revmacentrum MUDr. Mostera, s.r.o.
Brno, Czech Republic, Czechia
Revmatologicky Ustav - Lekarna (pharmacy only)
Prague, Czech Republic, Czechia
Revmatologicka ambulance
Prague, Czech Republic, Czechia
MEDIGAP, s.r.o. (radiology only)
Praha 1 - Nove Mesto, Czech Republic, Czechia
Lekarna Na Lidicke (Pharmacy only)
Brno, , Czechia
X-MEDICA s.r.o (radiology only)
Brno, , Czechia
Revmatologie s.r.o.
Brno, , Czechia
Stavovska s.r.o. (pharmacy only)
Brno, , Czechia
Vesalion s.r.o.
Ostrava, , Czechia
Revmatologicky ustav - Lekarna
Prague, , Czechia
Revmatologicky ustav
Prague, , Czechia
MEDIGAP, s.r.o
Praha 1- Nove Mesto, , Czechia
Medical Plus s.r.o. Lekarna Hradebni s. r.o
Uherské Hradiště, , Czechia
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
Corbeil-Essonnes, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Rheumapraxis Steglitz
Berlin, , Germany
University Hospital of Cologne
Cologne, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Revita Reumatologiai Rendelo
Budapest, , Hungary
Qualiclinic Kft.
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly
Budapest, , Hungary
Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only
Veszprém, , Hungary
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
Veszprém, , Hungary
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
Culiacán, Sinaloa, Mexico
Laboratorios de Analisis Clinicos CEMSI
Culiacán, Sinaloa, Mexico
Sanatorio CEMSI Chapultepec (For Emergencies Only)
Culiacán, Sinaloa, Mexico
Hospital General de Culiacán Dr. Bernardo J. Gastélum
Culiacán, Sinaloa, Mexico
Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)
Mérida, Yucatán, Mexico
Unidad Reumatologica Las Americas, S.C.P.
Mérida, Yucatán, Mexico
Centro de Investigacion Clinica Pensiones
Mérida, Yucatán, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Mérida, Yucatán, Mexico
Hospital Star Medica Merida (For Emergencies Only)
Mérida, Yucatán, Mexico
HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)
Mérida, Yucatán, Mexico
Investigacion y Biomedicina de Chihuahua SC
Chihuahua City, , Mexico
Cliditer, S. A. de C. V
Mexico City, , Mexico
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 Badurski i wspolnicy 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 for X-Ray only
Elblag, , Poland
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag, , Poland
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
Grodzisk Mazowiecki, , Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin, , Poland
NZOZ Lecznica MAK-MED S.C.
Nadarzyn, , Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
Poznan, , Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Torun, , Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, , Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Reumatika Centrum Reumatologii
Warsaw, , Poland
Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddz. we Wroclawiu
Wroclaw, , Poland
Regional State Budgetary Healthcare Institution of Karelia Republic
Petrozavodsk, Karelia Republic, Russia
State Budgetary Institution of Healthcare of Moscow City Clinical Hospital
Moscow, , Russia
OOO City Neurological Centre "Sibneiromed"
Novosibirsk, , Russia
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
Novosibirsk, , Russia
State Institution of Healthcare "Regional Clinical Hospital"
Saratov, , Russia
State Budget Educational Institution of Highest Professional Education
Tomsk, , Russia
State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, , Russia
State Institution of Healthcare of Yaroslavl Region
Yaroslavl, , Russia
ROMJAN s.r.o., Reumatologicka ambulancia
Bratislava, Slovak Republic, Slovakia
MEDMAN s.r.o. - reumatologicka ambulancia
Martin, Slovak Republic, Slovakia
Nestatna reumatologicka ambulancia
Bratislava, , Slovakia
Reumex s.r.o
Rimavská Sobota, , Slovakia
Hospital Clinico de Santiago
Santiago de Compostela, A Coruna, Spain
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Infanta Luisa
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Taipei Veterans General Hospital
Taipei, Taiwan Roc, Taiwan
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
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 Infirmary, BTHFT
Bradford, West Yorkshire, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Upton, Wirral, 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.
Mease 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.
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.
Dougados 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.
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.
Schneeberger 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.
de 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.
Orbai 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.
Taylor 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.
Gladman 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.
Dikranian 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.
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.
Kivitz 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.
de 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.
Coates 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.
Ritchlin 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.
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.
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.
Cella 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.
van 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.
Strand 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.
Cella 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.
Nash 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.
Helliwell 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.
Mease 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.
Related Links
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Other Identifiers
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2011-003668-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921091
Identifier Type: -
Identifier Source: org_study_id
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