{"id":"cnto-148","safety":{"commonSideEffects":[{"rate":null,"effect":"Infections (including serious infections)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Upper respiratory tract infections"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CNTO 148 binds to and neutralizes TNF-α, a key pro-inflammatory cytokine involved in the pathogenesis of autoimmune and inflammatory conditions. By inhibiting TNF-α signaling, the drug suppresses excessive immune activation and reduces inflammation in affected tissues. This mechanism is similar to other TNF inhibitors used in rheumatologic and gastrointestinal inflammatory diseases.","oneSentence":"CNTO 148 is a monoclonal antibody that blocks tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling in immune-mediated diseases.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:06:31.077Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Golimumab","title":"Golimumab","extract":"Golimumab, sold under the brand name Simponi, is a human monoclonal antibody which is used as an immunosuppressive medication. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor. Reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism. Golimumab is given via subcutaneous injection."},"indications":{"approved":[{"name":"Rheumatoid arthritis"},{"name":"Crohn's disease"},{"name":"Ulcerative colitis"}]},"trialDetails":[{"nctId":"NCT05071664","phase":"PHASE2","title":"A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2021-10-25","conditions":"Arthritis, Psoriatic","enrollment":91},{"nctId":"NCT05960578","phase":"PHASE2","title":"Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Washington","startDate":"2024-05-23","conditions":"Metastatic Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8","enrollment":8},{"nctId":"NCT02414984","phase":"","title":"Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab","status":"TERMINATED","sponsor":"Janssen-Cilag, S.A.","startDate":"2015-03","conditions":"Rheumatoid Arthritis","enrollment":37},{"nctId":"NCT01988961","phase":"PHASE2","title":"A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2013-12","conditions":"Colitis, Ulcerative","enrollment":103},{"nctId":"NCT00488631","phase":"PHASE3","title":"An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2007-09","conditions":"Colitis, Ulcerative","enrollment":1228},{"nctId":"NCT01230827","phase":"PHASE3","title":"A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2010-12","conditions":"Juvenile Idiopathic Arthritis","enrollment":173},{"nctId":"NCT01692457","phase":"","title":"A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis","status":"WITHDRAWN","sponsor":"Janssen Pharmaceutica","startDate":"2013-07","conditions":"Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis","enrollment":""},{"nctId":"NCT00771251","phase":"PHASE3","title":"A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2008-05","conditions":"Rheumatoid Arthritis","enrollment":311},{"nctId":"NCT00675649","phase":"PHASE2","title":"A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma","status":"WITHDRAWN","sponsor":"Centocor, Inc.","startDate":"2008-05","conditions":"Asthma","enrollment":""},{"nctId":"NCT00955279","phase":"PHASE2","title":"A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2009-11","conditions":"Sarcoidosis","enrollment":173},{"nctId":"NCT01288157","phase":"PHASE1","title":"A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2010-09","conditions":"Healthy Adult Chinese Males","enrollment":24},{"nctId":"NCT00299546","phase":"PHASE3","title":"A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2006-02","conditions":"Arthritis, Rheumatoid","enrollment":461},{"nctId":"NCT00487539","phase":"PHASE2, PHASE3","title":"An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2007-08","conditions":"Colitis, Ulcerative","enrollment":1065},{"nctId":"NCT00973479","phase":"PHASE3","title":"An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2009-09","conditions":"Arthritis, Rheumatoid","enrollment":592},{"nctId":"NCT01258777","phase":"PHASE1","title":"A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2010-10","conditions":"Healthy Volunteers","enrollment":49},{"nctId":"NCT00265083","phase":"PHASE3","title":"A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2005-12","conditions":"Spondylitis, Ankylosing","enrollment":356},{"nctId":"NCT00488774","phase":"PHASE2, PHASE3","title":"An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2007-08","conditions":"Colitis, Ulcerative","enrollment":291},{"nctId":"NCT00727987","phase":"PHASE3","title":"A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2008-05","conditions":"Rheumatoid Arthritis","enrollment":269},{"nctId":"NCT00207714","phase":"PHASE2","title":"An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2003-11","conditions":"Rheumatoid Arthritis","enrollment":172},{"nctId":"NCT00207740","phase":"PHASE2","title":"A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2004-08","conditions":"Asthma","enrollment":309}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Golimumab"],"phase":"phase_3","status":"active","brandName":"CNTO 148","genericName":"CNTO 148","companyName":"Janssen Pharmaceutical K.K.","companyId":"janssen-pharmaceutical-k-k","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CNTO 148 is a monoclonal antibody that blocks tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling in immune-mediated diseases. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":5,"withResults":4},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}