Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
OPAL BEYOND
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
2 other identifiers
interventional
395
14 countries
125
Brief Summary
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
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 Aug 2013
Typical duration for phase_3
125 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 18, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedSeptember 15, 2017
September 1, 2017
2.7 years
June 18, 2013
February 17, 2017
September 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 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).
Month 3
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3
The HAQ-DI assesses the difficulty a patient 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. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.
Month 3
Secondary Outcomes (36)
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6
Week 2 and Months 1, 2, 3, 4, and 6
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6
Week 2 and Months 1, 2, 3, 4, and 6
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6
Week 2 and Months 1, 2, 4, and 6
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6
Week 2 and Months 1, 2, 4, and 6
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3
Month 3
- +31 more secondary outcomes
Study Arms (4)
Treatment Sequence A
EXPERIMENTALTofacitinib 5 mg BID for 6 months
Treatment Sequence B
EXPERIMENTALTofacitinib 10 mg BID for 6 months
Treatment Sequence C
PLACEBO COMPARATORPlacebo for 3 months then tofacitinib 5 mg BID for 3 months
Treatment Sequence D
PLACEBO COMPARATORPlacebo for 3 months then tofacitinib 10 mg BID for 3 months
Interventions
Eligibility Criteria
You may qualify if:
- Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints
- Active plaque psoriasis at screening
- Inadequate efficacy or lack of toleration to previously administered TNF inhibitor
You may not qualify if:
- Non-plaque forms of psoriasis (with exception of nail psoriasis)
- History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (125)
Rheumatology Associates P.C.
Birmingham, Alabama, 35205, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801-4414, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306, United States
Medvin Clinical Research
Covina, California, 91723, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095, United States
UCLA David Geffen School of Medicine
Los Angeles, California, 90095, United States
San Diego Arthritis Medical Clinic
San Diego, California, 92108, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc.
Palm Harbor, Florida, 34684, United States
Integral Rheumatology & Immunology Specialists (IRIS)
Plantation, Florida, 33324, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
St. Luke's Clinic - Rheumatology
Boise, Idaho, 83702, United States
St. Luke's Intermountain Research Center
Boise, Idaho, 83702, United States
Bluegrass Community Research, Inc
Lexington, Kentucky, 40504, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
The Center For Rheumatology And Bone Research
Wheaton, Maryland, 20902, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
St. Paul Rheumatology, PA
Eagan, Minnesota, 55121, United States
Clayton Medical Research
St Louis, Missouri, 63117, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, 03756, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, 18015, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Arthritis Clinic
Jackson, Tennessee, 38305, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Adriana M. Pop-Moody, M.D., Clinic, P.A.
Corpus Christi, Texas, 78404, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, 77429, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Drug Shipment/Storage: Investigational Drug Services
Salt Lake City, Utah, 84112, United States
University of Utah Hospital & Clinics
Salt Lake City, Utah, 84132, United States
Dynacare Laboratories
Seattle, Washington, 98122, United States
Seattle Rheumatology Associates
Seattle, Washington, 98122, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Royal Prince Alfred Hospital, Rheumatology Department
Camperdown, New South Wales, 2050, Australia
Rheumatology Research Unit
Maroochydore, Queensland, 4558, Australia
Emeritus Research Pty Ltd
Malvern East, Victoria, 3145, Australia
Hospital Erasme - Clinique Universitaire de Bruxelles
Brussels, 1070, Belgium
ReumaClinic
Genk, 3600, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
University Hospital Leuven, Department of Rheumatology
Leuven, 3000, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
CMIP: Centro Mineiro de Pesquisa Ltda /
Juiz de Fora, Minas Gerais, 36010-570, Brazil
CETAC - DIAGNOSTICO POR IMAGEM (image only)
Curitiba, ParanĂ¡, 80240-160, Brazil
EDUMED - Educacao em Saude SS LTDA.
Curitiba, ParanĂ¡, 80440-080, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli
Campinas, SĂ£o Paulo, 13015-001, Brazil
Radiologia ClĂnica de Campinas - RCC (Images only)
Campinas, SĂ£o Paulo, 13015-240, Brazil
Medical Plus s.r.o.
UherskĂ© HradiÅ¡tÄ›, 68601, Czechia
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
Corbeil-Essonnes, Cedex, 91106, France
Hopital Avicenne
Bobigny, 93000, France
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, 18209, Germany
Charite Universitatsmedizin Berlin - Campus Charite Mitte
Berlin, 10117, Germany
Rheumapraxis Steglitz
Berlin, 12161, Germany
Schlosspark-Klinik
Berlin, 14059, Germany
University Hospital of Cologne
Cologne, 50937, Germany
Universitaetsklinikum Erlangen, Medizinische Klinik 3
Erlangen, 91054, Germany
CIRI - Centrum fĂ¼r innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)
Frankfurt am Main, 60528, Germany
Medizinische Universitatsklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, 66421, Germany
Elisabeth Klinik Bigge
Olsberg, 59939, Germany
Hospital Angeles Clinica Londres
Mexico City, D.F, 06700, Mexico
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, 44160, Mexico
Grupo Santa Bernardette S.A. de C.V.
Guadalajara, Jalisco, 44200, Mexico
Grupo Medico Camino S.C.
Mexico City, Mexico City, 03310, Mexico
CLIDITER, S.A. de C.V.
Mexico City, Mexico City, 06700, Mexico
Universidad La Salle AC
Mexico City, Mexico City, 14000, Mexico
Medica Sur, S.A.B. de C.V. (For Emergencies Only)
Mexico City, Mexico City, 14050, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
CuliacĂ¡n, Sinaloa, 80000, Mexico
Sanatorio CEMSI Chapultepec (For Emergencies Only)
CuliacĂ¡n, Sinaloa, 80040, Mexico
Hospital General de Culiacan "Dr. Bernardo J. Gastelum"
CuliacĂ¡n, Sinaloa, 80230, Mexico
Star Medica S.A. de C.V. (For Emergencies Only)
Merdia, YucatĂ¡n, 97133, Mexico
Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)
MĂ©rida, YucatĂ¡n, 97000, Mexico
Unidad Reumatologica Las Americas SCP
MĂ©rida, YucatĂ¡n, 97000, Mexico
Centro de Investigacion Clinica Pensiones
MĂ©rida, YucatĂ¡n, 97070, Mexico
Centro Multidisciplinario para el Desarrollo
MĂ©rida, YucatĂ¡n, 97130, Mexico
Hospital Star Medica Merida (For Emergencies Only)
MĂ©rida, YucatĂ¡n, 97133, Mexico
Christus Muguerza del parque, S.A de C.V
Chihuahua City, 31000, Mexico
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez
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
Wojewodzki Szpital Zespolony Zaklad Radiologii
Elblag, 82-300, Poland
Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only
Grodzisk Mazowiecki, 05-825, Poland
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
Lodz, 90-265, Poland
NZOZ Lecznica MAK-MED S.C.
Nadarzyn, 05-830, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
Poznan, 61-397, Poland
Reumatika Centrum Reumatologii nzoz
Warsaw, 02-691, Poland
Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.
Petrozavodsk, Karelia Republic, 185019, Russia
State Autonomic Healthcare Institution City Clinical Hospital # 7
Kazan', Republic of Tatarstan, Russia, 420103, Russia
SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
Moscow, 119049, Russia
City Neurological Centre "SibNeyroMed", LLC
Novosibirsk, 630091, Russia
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
Novosibirsk, 630099, Russia
State Budget Educational Institution of Highest Professional Education
Tomsk, 634050, Russia
State Institution of Healthcare of Yaroslavl Region
Yaroslavl, 150003, Russia
MEDMAN s.r.o. - reumatologicka ambulancia
Martin, 036 01, Slovakia
Hospital Clinico de Santiago
Santiago de Compostela, A Coruna, 15706, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Sierrallana
Torrelavega, Cantabria, 39300, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitaro 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
China Medical University Hospital
Taichung, 40447, Taiwan
Barking Havering and Redbridge University Hospitals NHS Trust
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 Royal Infirmary, BTHFT
Bradford, West Yorkeshire, BD9 6RJ, United Kingdom
Royal United Hospitals NHS Foundation Trust
Bath, BA1 1RL, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD5 0NA, United Kingdom
York Hospital, York Teaching Hospital NHS Foundation Trust
York, YO31 8HE, United Kingdom
Related Publications (28)
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 D, Tillett W, Gruben D, Coates LC, Hahne S, Volkov M. Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies. RMD Open. 2025 Jun 3;11(2):e005250. doi: 10.1136/rmdopen-2024-005250.
PMID: 40461265DERIVEDGladman 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: 40241921DERIVEDMease 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: 31111255DERIVEDStrand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Chen L, Kudlacz E, Wu J, Cappelleri JC, Hendrikx T, Hsu MA. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond. RMD Open. 2019 Jan 11;5(1):e000808. doi: 10.1136/rmdopen-2018-000808. eCollection 2019.
PMID: 30713722DERIVEDCella 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: 30373651DERIVEDGladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-1536. doi: 10.1056/NEJMoa1615977.
PMID: 29045207DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2013
First Posted
June 20, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
September 15, 2017
Results First Posted
September 15, 2017
Record last verified: 2017-09