{"id":"sc-golimumab","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Injection site reaction"},{"rate":"10-20%","effect":"Headache"},{"rate":"10-20%","effect":"Fatigue"},{"rate":"5-10%","effect":"Nausea"},{"rate":"5-10%","effect":"Diarrhea"}]},"_chembl":{"chemblId":"CHEMBL1201833","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"This mechanism of action is based on the role of TNF-alpha in mediating inflammation and contributing to various autoimmune and inflammatory diseases. By blocking TNF-alpha, SC golimumab reduces inflammation and slows disease progression.","oneSentence":"SC golimumab is a monoclonal antibody that binds to tumor necrosis factor-alpha (TNF-alpha), preventing its interaction with cell surface TNF receptors and subsequent inflammatory response.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:33:36.740Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis"},{"name":"Psoriatic arthritis"},{"name":"Ankylosing spondylitis"}]},"trialDetails":[{"nctId":"NCT05242484","phase":"PHASE2","title":"A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2022-09-19","conditions":"Colitis, Ulcerative","enrollment":577},{"nctId":"NCT03596645","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2018-10-29","conditions":"Colitis, Ulcerative","enrollment":84},{"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":"NCT05305066","phase":"NA","title":"Stand UP to Rheumatoid Arthritis (SUPRA)","status":"RECRUITING","sponsor":"Marie Hudson, MD","startDate":"2023-02-01","conditions":"Rheumatoid Arthritis","enrollment":75},{"nctId":"NCT05242471","phase":"PHASE2","title":"A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2022-07-22","conditions":"Crohn's Disease","enrollment":703},{"nctId":"NCT04435288","phase":"PHASE3","title":"Spondyloarthritis: Inducing Drug-free Remission by Early TNF-alpha Blockade","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Hospital, Ghent","startDate":"2020-08-24","conditions":"Peripheral Spondyloarthritis","enrollment":90},{"nctId":"NCT02438787","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2015-07-31","conditions":"Axial Spondyloarthritis","enrollment":315},{"nctId":"NCT02437162","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2015-09-03","conditions":"Axial Spondyloarthritis","enrollment":347},{"nctId":"NCT03733925","phase":"PHASE4","title":"A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis","status":"COMPLETED","sponsor":"Johnson & Johnson Private Limited","startDate":"2019-01-07","conditions":"Spondylitis, Ankylosing, Arthritis, Psoriatic","enrollment":100},{"nctId":"NCT02846545","phase":"PHASE2","title":"A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2016-08-26","conditions":"Diabetes Mellitus, Type 1","enrollment":84},{"nctId":"NCT03298542","phase":"PHASE1","title":"A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-10-16","conditions":"Pre-Symptomatic Type 1 Diabetes","enrollment":8},{"nctId":"NCT03557853","phase":"","title":"Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab","status":"COMPLETED","sponsor":"MSD Pharmaceuticals LLC","startDate":"2016-06","conditions":"Ankylosing Spondylitis, Coxitis","enrollment":39},{"nctId":"NCT04156984","phase":"PHASE4","title":"Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis","status":"COMPLETED","sponsor":"David Drobne","startDate":"2021-04-07","conditions":"Ulcerative Colitis","enrollment":27},{"nctId":"NCT03662542","phase":"PHASE2","title":"A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-11-20","conditions":"Colitis, Ulcerative","enrollment":214},{"nctId":"NCT03253796","phase":"PHASE4","title":"Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2017-11-07","conditions":"Spondyloarthritis","enrollment":323},{"nctId":"NCT03945903","phase":"","title":"Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults","status":"NO_LONGER_AVAILABLE","sponsor":"Janssen Research & Development, LLC","startDate":"","conditions":"Diabetes Mellitus, Type 1","enrollment":""},{"nctId":"NCT03632759","phase":"EARLY_PHASE1","title":"Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D","status":"COMPLETED","sponsor":"Carla Greenbaum, MD","startDate":"2018-08-15","conditions":"Type 1 Diabetes Mellitus","enrollment":16},{"nctId":"NCT05164198","phase":"PHASE4","title":"REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)","status":"UNKNOWN","sponsor":"Hanyang University Seoul Hospital","startDate":"2022-01-15","conditions":"Ankylosing Spondylitis, Axial Spondyloarthritis","enrollment":448},{"nctId":"NCT02318667","phase":"PHASE4","title":"Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-02-27","conditions":"Colitis, Ulcerative","enrollment":38},{"nctId":"NCT01764321","phase":"","title":"Noninterventional Examination of Subcutaneous (sc) Tumor Necrosis Factor (TNF) Inhibitors","status":"COMPLETED","sponsor":"UCB Pharma SA","startDate":"2012-12","conditions":"Rheumatoid Arthritis","enrollment":1723},{"nctId":"NCT02092285","phase":"PHASE4","title":"Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-05-09","conditions":"Ulcerative Colitis","enrollment":205},{"nctId":"NCT01453725","phase":"PHASE3","title":"Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-02-13","conditions":"Spondylitis, Ankylosing","enrollment":198},{"nctId":"NCT01362153","phase":"PHASE1","title":"A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2007-12-26","conditions":"Rheumatoid Arthritis","enrollment":49},{"nctId":"NCT01217814","phase":"PHASE2","title":"Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers","status":"TERMINATED","sponsor":"Sanofi","startDate":"2010-11","conditions":"Rheumatoid Arthritis","enrollment":16},{"nctId":"NCT00975130","phase":"PHASE3","title":"Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-09","conditions":"Arthritis, Rheumatoid","enrollment":3366},{"nctId":"NCT01863771","phase":"PHASE3","title":"A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2013-03-15","conditions":"Colitis, Ulcerative","enrollment":144},{"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":"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":"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":"NCT01004432","phase":"PHASE3","title":"Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)","status":"COMPLETED","sponsor":"Janssen Biotech, Inc.","startDate":"2009-12","conditions":"Arthritis, Arthritis, Rheumatoid, Autoimmune Diseases","enrollment":433},{"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":"NCT00264537","phase":"PHASE3","title":"A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2005-12","conditions":"Rheumatoid Arthritis","enrollment":637},{"nctId":"NCT00361335","phase":"PHASE3","title":"A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2006-09","conditions":"Rheumatoid Arthritis","enrollment":643},{"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":"NCT00264550","phase":"PHASE3","title":"An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2005-12","conditions":"Rheumatoid Arthritis","enrollment":444},{"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":"NCT01248780","phase":"PHASE3","title":"Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2010-09","conditions":"Rheumatoid Arthritis","enrollment":264},{"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":"NCT00265096","phase":"PHASE3","title":"A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2005-12","conditions":"Arthritis, Psoriatic","enrollment":407},{"nctId":"NCT01248793","phase":"PHASE3","title":"Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis","status":"COMPLETED","sponsor":"Centocor, Inc.","startDate":"2010-10","conditions":"Ankylosing Spondylitis","enrollment":213}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["SCH 900259, subcutaneous"],"phase":"phase_3","status":"active","brandName":"SC golimumab","genericName":"SC golimumab","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"SC golimumab is a monoclonal antibody that binds to tumor necrosis factor-alpha (TNF-alpha), preventing its interaction with cell surface TNF receptors and subsequent inflammatory response. Used for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}