{"id":"ct-p13-sc-infliximab","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"},{"rate":null,"effect":"Tuberculosis reactivation"},{"rate":null,"effect":"Malignancy risk"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Infliximab is a chimeric monoclonal antibody that binds to and neutralizes TNF-alpha, a key pro-inflammatory cytokine. By blocking TNF-alpha signaling, it suppresses the inflammatory cascade underlying autoimmune and inflammatory diseases. 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INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB","status":"UNKNOWN","sponsor":"IRCCS San Raffaele","startDate":"2022-09-14","conditions":"Inflammatory Bowel Diseases, Rheumatologic Disease","enrollment":250},{"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":"NCT02883452","phase":"PHASE1","title":"A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis","status":"COMPLETED","sponsor":"Celltrion","startDate":"2016-09-29","conditions":"Crohn's Disease, Ulcerative Colitis (Part 2 Only)","enrollment":181},{"nctId":"NCT03147248","phase":"PHASE3","title":"A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA","status":"COMPLETED","sponsor":"Celltrion","startDate":"2016-09-12","conditions":"Rheumatoid Arthritis","enrollment":407},{"nctId":"NCT03446976","phase":"PHASE1","title":"CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2018-02-21","conditions":"Health, Subjective","enrollment":218}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":16,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"CT-P13 SC (Infliximab)","genericName":"CT-P13 SC (Infliximab)","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P13 SC is a subcutaneous formulation of infliximab, a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha to reduce inflammation. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}