{"id":"tofacitinib-with-methotrexate","safety":{"commonSideEffects":[{"rate":"~15–20%","effect":"Upper respiratory tract infection"},{"rate":"~10–15%","effect":"Diarrhea"},{"rate":"~8–12%","effect":"Nausea"},{"rate":"~8–10%","effect":"Headache"},{"rate":"~5–10%","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"~5–8%","effect":"Hypertension"},{"rate":"~1–3%","effect":"Serious infections"},{"rate":"~5–10%","effect":"Lipid elevation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tofacitinib is a JAK inhibitor that blocks JAK1 and JAK3 preferentially, disrupting the intracellular signaling of multiple inflammatory cytokines (IL-6, IL-23, IFN-γ, and others). Methotrexate acts as a disease-modifying antirheumatic drug (DMARD) by inhibiting dihydrofolate reductase and reducing cell proliferation. The combination provides synergistic immunosuppression for treating rheumatoid arthritis and other inflammatory conditions.","oneSentence":"Tofacitinib inhibits Janus kinase (JAK) enzymes to suppress inflammatory cytokine signaling, while methotrexate provides additional immunosuppression through antifolate activity.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:13:06.880Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis (moderate to severe, active)"},{"name":"Polyarticular course juvenile idiopathic arthritis"}]},"trialDetails":[{"nctId":"NCT07472166","phase":"PHASE4","title":"Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate","status":"COMPLETED","sponsor":"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","startDate":"2024-12-21","conditions":"Scleroderma, Systemic","enrollment":34},{"nctId":"NCT07406204","phase":"PHASE4","title":"Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)","status":"NOT_YET_RECRUITING","sponsor":"Hayat Abad Medical Complex, Peshawar","startDate":"2026-02-15","conditions":"Alopecia Areata, Alopecia Totalis (AT), Alopecia Universalis","enrollment":78},{"nctId":"NCT04259138","phase":"PHASE4","title":"Determination of the Optimal Treatment Target in Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alimentiv Inc.","startDate":"2020-02-18","conditions":"Colitis, Ulcerative","enrollment":672},{"nctId":"NCT06301373","phase":"NA","title":"Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis","status":"RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2024-09-01","conditions":"Rheumatoid Arthritis","enrollment":130},{"nctId":"NCT07138898","phase":"PHASE2","title":"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty","status":"NOT_YET_RECRUITING","sponsor":"NYU Langone Health","startDate":"2025-09","conditions":"Rheumatic Disease","enrollment":80},{"nctId":"NCT06172361","phase":"PHASE3","title":"Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica","status":"RECRUITING","sponsor":"Zhejiang University","startDate":"2024-01-20","conditions":"Polymyalgia Rheumatica","enrollment":98},{"nctId":"NCT03414502","phase":"PHASE3","title":"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response","status":"RECRUITING","sponsor":"University of Nebraska","startDate":"2007-12-10","conditions":"Rheumatoid Arthritis","enrollment":400},{"nctId":"NCT07008846","phase":"PHASE3","title":"Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","startDate":"2025-05-10","conditions":"Moderate to Severe Rheumatoid Arthritis","enrollment":96},{"nctId":"NCT06089590","phase":"","title":"Ibd CAncer and seRious Infections in France (I-CARE 2)","status":"RECRUITING","sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","startDate":"2024-01-25","conditions":"IBD, Ulcerative Colitis, Crohn Disease","enrollment":6000},{"nctId":"NCT02714634","phase":"PHASE4","title":"Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide","status":"RECRUITING","sponsor":"University Hospital, Strasbourg, France","startDate":"2016-03-30","conditions":"Rheumatoid Arthritis, Insufficient Response to Methotrexate or Leflunomide","enrollment":286},{"nctId":"NCT04871191","phase":"PHASE3","title":"Study of Salvage Therapy to Treat Patients with Granulomatosis with Polyangiitis","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2025-03","conditions":"Granulomatosis with Polyangiitis, Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis","enrollment":42},{"nctId":"NCT01848028","phase":"","title":"PsoBest - The German Psoriasis Registry","status":"RECRUITING","sponsor":"Universitätsklinikum Hamburg-Eppendorf","startDate":"2008-01","conditions":"Psoriasis, Psoriatic-arthritis","enrollment":3500},{"nctId":"NCT04084223","phase":"NA","title":"JAKPOT (JAK Inhibitors and Predictors of Outcome in RheumaToid Arthritis)","status":"TERMINATED","sponsor":"University Hospital, Montpellier","startDate":"2019-10-10","conditions":"Rheumatoid Arthritis","enrollment":51},{"nctId":"NCT06498089","phase":"PHASE4","title":"A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis","status":"RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2024-06-28","conditions":"Takayasu Arteritis","enrollment":124},{"nctId":"NCT05102448","phase":"PHASE4","title":"Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis","status":"RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2021-11-01","conditions":"Takayasu Arteritis","enrollment":76},{"nctId":"NCT04311567","phase":"PHASE4","title":"Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease","status":"TERMINATED","sponsor":"Vastra Gotaland Region","startDate":"2020-11-07","conditions":"Rheumatoid Arthritis, Interstitial Lung Disease Due to Systemic Disease (Disorder), RA","enrollment":3},{"nctId":"NCT00847613","phase":"PHASE3","title":"A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-03","conditions":"Arthritis, Rheumatoid","enrollment":800},{"nctId":"NCT03980483","phase":"PHASE3","title":"Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-05-16","conditions":"Arthritis, Rheumatoid","enrollment":1537},{"nctId":"NCT05696106","phase":"","title":"Risk of Incident IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-04-02","conditions":"Inflammatory Disease","enrollment":750000},{"nctId":"NCT04413617","phase":"PHASE2","title":"TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-07-29","conditions":"Rheumatoid Arthritis","enrollment":460},{"nctId":"NCT04610476","phase":"PHASE3","title":"Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis","status":"UNKNOWN","sponsor":"University of Erlangen-Nürnberg Medical School","startDate":"2020-10-19","conditions":"Psoriatic Arthritis, Withdrawal, Reduction","enrollment":270},{"nctId":"NCT04944524","phase":"PHASE4","title":"Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","startDate":"2021-07-01","conditions":"Granulomatosis With Polyangiitis","enrollment":66},{"nctId":"NCT04927000","phase":"PHASE4","title":"The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2021-05-31","conditions":"Rheumatoid Arthritis","enrollment":170},{"nctId":"NCT03011281","phase":"","title":"Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis","status":"UNKNOWN","sponsor":"Hanyang University","startDate":"2016-09","conditions":"Rheumatoid Arthritis","enrollment":378},{"nctId":"NCT04299971","phase":"PHASE4","title":"Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","startDate":"2020-03-01","conditions":"Takayasu Arteritis, Methotrexate, Inhibition","enrollment":130},{"nctId":"NCT02996500","phase":"PHASE2","title":"Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-11-10","conditions":"Rheumatoid Arthritis","enrollment":269},{"nctId":"NCT02831855","phase":"PHASE4","title":"Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-09-01","conditions":"Rheumatoid Arthritis","enrollment":694},{"nctId":"NCT03736161","phase":"PHASE3","title":"Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis","status":"COMPLETED","sponsor":"Globe Pharmaceuticals Limited","startDate":"2017-09-15","conditions":"Psoriatic Arthritis","enrollment":61},{"nctId":"NCT00960440","phase":"PHASE3","title":"Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-10","conditions":"Arthritis, Rheumatoid","enrollment":399},{"nctId":"NCT02281552","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-11-18","conditions":"Rheumatoid Arthritis","enrollment":209},{"nctId":"NCT02187055","phase":"PHASE4","title":"An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-08","conditions":"Rhematoid Arthritis","enrollment":1152},{"nctId":"NCT02147587","phase":"PHASE2","title":"A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-06","conditions":"Rheumatoid Arthritis","enrollment":112},{"nctId":"NCT01039688","phase":"PHASE3","title":"Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-01","conditions":"Arthritis, Rheumatoid","enrollment":956},{"nctId":"NCT01741493","phase":"PHASE1","title":"A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2012-11","conditions":"Rheumatoid Arthritis","enrollment":67},{"nctId":"NCT01164579","phase":"PHASE2","title":"Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-10","conditions":"Rheumatoid Arthritis","enrollment":109},{"nctId":"NCT01359150","phase":"PHASE2","title":"A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-09","conditions":"Rheumatoid Arthritis","enrollment":223},{"nctId":"NCT01745055","phase":"PHASE1","title":"Co-Administration Of Methotrexate And CP-690,550","status":"COMPLETED","sponsor":"Pfizer","startDate":"2005-04","conditions":"Rheumatoid Arthritis","enrollment":12},{"nctId":"NCT00603512","phase":"PHASE2","title":"Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-01","conditions":"Arthritis, Rheumatoid","enrollment":140},{"nctId":"NCT00413660","phase":"PHASE2","title":"Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2007-01","conditions":"Arthritis, Rheumatoid","enrollment":509},{"nctId":"NCT00853385","phase":"PHASE3","title":"A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-05","conditions":"Rheumatoid Arthritis","enrollment":717},{"nctId":"NCT00976599","phase":"PHASE2","title":"A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-11","conditions":"Rheumatoid Arthritis","enrollment":29}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Tofacitinib with methotrexate","genericName":"Tofacitinib with methotrexate","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tofacitinib, also known as CP-690,550, is being studied in combination with methotrexate for the treatment of Takayasu arteritis, a form of arthritis. This combination is being investigated in a randomized open-label study, NCT04299971, titled \"Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients\" at Shanghai Zhongshan Hospital.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}