Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis
NCT ID: NCT02831855
Last Updated: 2019-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
694 participants
INTERVENTIONAL
2016-09-01
2018-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
NCT02281552
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
NCT02187055
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
NCT01976364
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
NCT00960440
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
NCT01164579
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CP-690,550 and methotrexate
Open-label tofacitinib tablet and blinded methotrexate capsule
CP-690,550
During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.
During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.
Methotrexate
During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.
During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.
CP-690,550 and placebo
open-label tofacitinib tablet and blinded matching placebo for methotrexate capsule
Placebo
During the double-blind phase, subjects who are randomized to the comparison arm will receive 11mg QD tofacitinib and the placebo capsules matching for methotrexate.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CP-690,550
During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.
During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.
Methotrexate
During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.
During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.
Placebo
During the double-blind phase, subjects who are randomized to the comparison arm will receive 11mg QD tofacitinib and the placebo capsules matching for methotrexate.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Have a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to Screening Visit.
* Have ≥4 tender/painful joints on motion and ≥4 swollen joints (28 joint counts) at both Screening Visit and Baseline Visit (Visit 1).
* Have moderate to severe disease activity as defined by CDAI\>10 and DAS28-4(ESR) ≥3.2 at Baseline Visit.
* Have taken an oral MTX treatment regimen (15-25mg/week) continuously for at least 4 months prior to the screening visit and has taken a stable weekly dose of oral MTX with supplemental folic acid or folinic acid for at least 4 weeks prior to the baseline visit (conversion from parenteral MTX to oral MTX will require stabilization of the treatment regimen for at least 1 month).
* Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent).
Exclusion Criteria
* Subjects with infection or infection history; subjects with any current malignancy or a history of malignancy (except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ); subjects with history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic); and subjects with history of documented diverticulitis.
* Subjects with a history of insufficient response to ≥2 biologics, regardless of the class.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Arthrocare, Arthritiscare & Research, PC
Gilbert, Arizona, United States
SunValley Arthritis Center, Ltd.
Peoria, Arizona, United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, United States
Med Investigations, Inc
Fair Oaks, California, United States
HCP Clinical Research, LLC
Huntington Beach, California, United States
Sierra Rheumatology
Roseville, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Robin K. Dore, MD, Inc.
Tustin, California, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Desert Valley Medical Group
Victorville, California, United States
AARDS Research Inc
Aventura, Florida, United States
RASF-Clinical Research Inc
Boca Raton, Florida, United States
Omega Research Consultants
DeBary, Florida, United States
University of Florida College of Medicine - Jacksonville - Rheumatology Research
Jacksonville, Florida, United States
University of Florida, Rheumatology at ACC
Jacksonville, Florida, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, United States
Jeffrey Alper, MD
Naples, Florida, United States
Medallion Clinical Research Institute, LLC
Naples, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Florida Arthritis & Osteoporosis Center
Port Richey, Florida, United States
Gulf Coast Medical Center
Port Richey, Florida, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
BayCare Medical Group, Inc
Tampa, Florida, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Quincy Medical Group
Quincy, Illinois, United States
Beacon Medical Group Rheumatology Main Street
Granger, Indiana, United States
Diagnostic Rheumatology and Research, PC
Indianapolis, Indiana, United States
Ochsner Clinic Baton Rouge
Baton Rouge, Louisiana, United States
Phase III Clinical Research
Fall River, Massachusetts, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Bronson Internal Medicine and Rheumatology
Battle Creek, Michigan, United States
Western Michigan University Homer Stryker MD
Kalamazoo, Michigan, United States
North Mississippi Medical Clinics, Inc. - Clinical Research
Tupelo, Mississippi, United States
Arthritis & Osteoporosis Associates
Freehold, New Jersey, United States
Radnet
Marlton, New Jersey, United States
Arthritis, Rheumatic & Back Disease Associates, P.A.
Voorhees Township, New Jersey, United States
Open MRI & Diagnostic Imaging of Wall
Wall, New Jersey, United States
AAIR Research Center
Rochester, New York, United States
Physicians East, PA
Greenville, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Trinity Health Center-Medical Arts
Minot, North Dakota, United States
Group Health Associates
Cincinnati, Ohio, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, United States
STAT Research, Inc.
Dayton, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Oklahoma Medical Research Foundation (OMRF)
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Piedmont Arthritis Clinic
Greenville, South Carolina, United States
Articularis Healthcare Group dba ACME Research
Orangeburg, South Carolina, United States
Articularis Healthcare Group d/b/a Low Country Rheumatology
Summerville, South Carolina, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Center for Arthritis and Rheumatic Diseases
Chesapeake, Virginia, United States
Center for Arthritis and Rheumatic Diseases
Suffolk, Virginia, United States
Genesis Research Services Pty Ltd
Broadmeadow, New South Wales, Australia
Optimus Clinical Research Pty Ltd
Kogarah, New South Wales, Australia
Rheumatology Research Unit
Maroochydore, Queensland, Australia
Emeritus Research
Melbourne, Victoria, Australia
ReumaClinic
Genk, , Belgium
AZ Delta
Roeselare, , Belgium
University Multiprofile Hospital for Active Treatment Dr. G. Stranski EAD
Pleven, , Bulgaria
Multiprofile Hospital for Active Treatment - Plovdiv AD, Rheumatology Department
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment Trimontium OOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment - Kaspela EOOD
Plovdiv, , Bulgaria
National Multiprofile Transport Hospital Tsar Boris III
Sofia, , Bulgaria
Medical Centre Synexus Sofia EOOD
Sofia, , Bulgaria
CCBR Czech Brno, s.r.o.
Brno, Czech Republic, Czechia
LEKARNA LANCIER s.r.o.
Brno, , Czechia
Lekarna Na Lidicke
Brno, , Czechia
Revmacentrum MUDr. Mostera, s.r.o., Revmatologie a interna
Brno, , Czechia
CCBR Ostrava, s.r.o.
Ostrava, , Czechia
Lekarna Rezidence Nova Karolina
Ostrava, , Czechia
Revmatologicky ustav, Lekrna
Prague, , Czechia
Revmatologicky ustav
Prague, , Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště, , Czechia
MEDICAL PLUS, s.r.o. Revmatologicka a osteologicka ambulance
Uherské Hradiště, , Czechia
PV - MEDICAL s.r.o., Revmatologicka ambulance
Zlín, , Czechia
Revmavita s.r.o, Lekarna
Zlín, , Czechia
Hamburger Rheuma Forschungszentrum I
Hamburg, , Germany
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, , Hungary
Revita Rendelo
Budapest, , Hungary
Qualiclinic Kft.
Budapest, , Hungary
CRU Hungary Kft.
Miskolc, , Hungary
Morales Vargas Centro de Investigacion SC (Consultorio Anexo)
León, Guanajuato, Mexico
Centro de Investigacion y Tratamiento Reumatologico SC Consultorio Medico de Reumatologia (CINTRE)
Mexico City, Mexico City, Mexico
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Far Eastern University - Nicanor Reyes Medical Foundation, Marian Medical Arts Bldg
Quezon City, National Capital Region, Philippines
Zdrowie OSTEO-MEDIC s.c. L i A. Racewicz, A i J. Supronik
Bialystok, , Poland
ClinicMed Daniluk, Nowak. Sp. j.
Bialystok, , Poland
Nzoz Bif - Med
Bytom, , Poland
Centrum Medyczne Pratia Krakow
Krakow, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Federal State Budgetary Scientific Institution "Research Institute of Rheumatology
Moscow, , Russia
FSBEI HE "Orenburg State Medical University" of MoH RF
Orenburg, , Russia
FSBEI HE "Orenburg State Medical University" of MoH RF
Orenburg, , Russia
FSBIH "Clinical Hospital #122 n.a. L.G. Sokolov" of FMBA of Russia
Saint Petersburg, , Russia
SPb SBIH "Consultative-Diagnostic Centre #85"
Saint Petersburg, , Russia
SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin"
Samara, , Russia
NSHI "Departmental Hospital at Smolensk station OJSC "Russian Railways"
Smolensk, , Russia
SAHI YR Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
Yaroslavl, , Russia
State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Hospital"
Yaroslavl, , Russia
AAGS s.r.o.
Dunajská Streda, , Slovakia
MEDMAN s.r.o.
Martin, , Slovakia
REUMACENTRUM s.r.o.
Partizánske, , Slovakia
MUDr. Zuzana Cizmarikova, s.r.o.
Poprad, , Slovakia
Reumex s.r.o
Rimavská Sobota, , Slovakia
St. Augustine's Hospital
Durban, KwaZulu-Natal, South Africa
Clinical Trial Pharmacy, KyungHee University Hospital
Seoul, , South Korea
KyungHee University Hospital
Seoul, , South Korea
CTC Pharmacy, Seoul National University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Clinical Trial Pharmacy, The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul, St. Mary's Hospital
Seoul, , South Korea
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruna, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain
Hospital Infanta Luisa
Seville, , Spain
Countess of Chester Hospital NHS Foundation Trust
Chester, Cheshire, United Kingdom
Pharmacy (dispensary)
Chester, Cheshire, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Ellesmere Port, Cheshire, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom
Pharmacy, Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom
Department of Rheumatology, Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Pharmacy Department, Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Pharmacy Department
Dudley, WEST Midlands, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, WEST Midlands, United Kingdom
Pharmacy
Manchester, , United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Karaman MW, Herrgard S, Treiber DK, Gallant P, Atteridge CE, Campbell BT, Chan KW, Ciceri P, Davis MI, Edeen PT, Faraoni R, Floyd M, Hunt JP, Lockhart DJ, Milanov ZV, Morrison MJ, Pallares G, Patel HK, Pritchard S, Wodicka LM, Zarrinkar PP. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008 Jan;26(1):127-32. doi: 10.1038/nbt1358.
Meyer DM, Jesson MI, Li X, Elrick MM, Funckes-Shippy CL, Warner JD, Gross CJ, Dowty ME, Ramaiah SK, Hirsch JL, Saabye MJ, Barks JL, Kishore N, Morris DL. Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond). 2010 Aug 11;7:41. doi: 10.1186/1476-9255-7-41.
Murray PJ. The JAK-STAT signaling pathway: input and output integration. J Immunol. 2007 Mar 1;178(5):2623-9. doi: 10.4049/jimmunol.178.5.2623.
O'Sullivan LA, Liongue C, Lewis RS, Stephenson SE, Ward AC. Cytokine receptor signaling through the Jak-Stat-Socs pathway in disease. Mol Immunol. 2007 Apr;44(10):2497-506. doi: 10.1016/j.molimm.2006.11.025. Epub 2007 Jan 17.
Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, Connell CA, Gruben D, Krishnaswami S, Wallenstein G, Wilkinson BE, Zwillich SH. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012 Mar;64(3):617-29. doi: 10.1002/art.33383.
Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS; ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):495-507. doi: 10.1056/NEJMoa1109071.
Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, Gruben D, Kanik KS, Krishnaswami S, Pascual-Ramos V, Wallenstein G, Zwillich SH. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum. 2012 Apr;64(4):970-81. doi: 10.1002/art.33419. Epub 2011 Oct 17.
Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, Isaacs JD, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Riese R, Bradley J. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):253-61. doi: 10.7326/0003-4819-159-4-201308200-00006.
Burmester GR, Benda B, Gruben D, Bradley J, Mebus C. Tofacitinib for rheumatoid arthritis - Authors' reply. Lancet. 2013 May 25;381(9880):1812-3. doi: 10.1016/S0140-6736(13)61115-0. No abstract available.
van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, Garcia Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B; ORAL Standard Investigators. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):508-19. doi: 10.1056/NEJMoa1112072.
Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, Aletaha D, Allaart CF, Bathon J, Bombardieri S, Brooks P, Brown A, Matucci-Cerinic M, Choi H, Combe B, de Wit M, Dougados M, Emery P, Furst D, Gomez-Reino J, Hawker G, Keystone E, Khanna D, Kirwan J, Kvien TK, Landewe R, Listing J, Michaud K, Martin-Mola E, Montie P, Pincus T, Richards P, Siegel JN, Simon LS, Sokka T, Strand V, Tugwell P, Tyndall A, van der Heijde D, Verstappen S, White B, Wolfe F, Zink A, Boers M; American College of Rheumatology; European League Against Rheumatism. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011 Mar;63(3):573-86. doi: 10.1002/art.30129.
Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol. 1982 Sep-Oct;9(5):789-93. No abstract available.
Ware JE KM, Dewey JE. . How to score Version 2 of the SF 36 Health Survey (Standard & Acute forms). In: How to score Version 2 of the SF 36 Health Survey (Standard & Acute forms). Lincoln, Rhode Island: QualityMetric, Incorporated. 2000.
Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol. 1997 May;36(5):551-9. doi: 10.1093/rheumatology/36.5.551.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002 Jan 15;94(2):528-38. doi: 10.1002/cncr.10245.
Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
Cohen SB, Pope J, Haraoui B, Irazoque-Palazuelos F, Korkosz M, Diehl A, Rivas JL, Lukic T, Liu S, Stockert L, Iikuni N, Keystone EC. Methotrexate withdrawal in patients with rheumatoid arthritis who achieve low disease activity with tofacitinib modified-release 11 mg once daily plus methotrexate (ORAL Shift): a randomised, phase 3b/4, non-inferiority trial. Lancet Rheumatol. 2019 Sep;1(1):e23-e34. doi: 10.1016/S2665-9913(19)30005-0. Epub 2019 Aug 6.
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.
Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
Fleischmann R, Haraoui B, Buch MH, Gold D, Sawyerr G, Shi H, Diehl A, Lee K. Analysis of Disease Activity Metrics in a Methotrexate Withdrawal Study among Patients with Rheumatoid Arthritis Treated with Tofacitinib plus Methotrexate. Rheumatol Ther. 2023 Apr;10(2):375-386. doi: 10.1007/s40744-022-00511-3. Epub 2022 Dec 19.
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.
Cohen SB, Haraoui B, Curtis JR, Smith TW, Woolcott J, Gruben D, Murray CW. Impact of Methotrexate Discontinuation, Interruption, or Persistence in US Patients with Rheumatoid Arthritis Initiating Tofacitinib + Oral Methotrexate Combination. Clin Ther. 2022 Jul;44(7):982-997.e2. doi: 10.1016/j.clinthera.2022.05.002. Epub 2022 Jun 4.
Cohen SB, Pope J, Haraoui B, Mysler E, Diehl A, Lukic T, Liu S, Stockert L, Germino R, Menon S, Shi H, Keystone EC. Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift). RMD Open. 2021 Jun;7(2):e001673. doi: 10.1136/rmdopen-2021-001673.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-001825-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921192
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.