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This therapeutic drug monitoring service measures infliximab serum concentrations and anti-drug antibodies to optimize dosing and predict treatment response or loss of efficacy in patients with inflammatory bowel disease and other TNF-α-mediated conditions.","oneSentence":"Infliximab is a chimeric monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:48:51.937Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Crohn's disease"},{"name":"Ulcerative colitis"},{"name":"Rheumatoid arthritis"},{"name":"Ankylosing spondylitis"},{"name":"Psoriasis"},{"name":"Psoriatic arthritis"}]},"trialDetails":[{"nctId":"NCT07470502","phase":"NA","title":"MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease","status":"RECRUITING","sponsor":"Meyer Children's Hospital IRCCS","startDate":"2025-02-13","conditions":"IBD (Inflammatory Bowel Disease)","enrollment":15},{"nctId":"NCT05781152","phase":"PHASE4","title":"Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease","status":"RECRUITING","sponsor":"Connecticut Children's Medical Center","startDate":"2023-06-10","conditions":"Crohn Disease","enrollment":900},{"nctId":"NCT05362630","phase":"","title":"Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study","status":"COMPLETED","sponsor":"University of Pisa","startDate":"2022-04-01","conditions":"Graft Versus Host Disease, Acute, Hematopoietic Stem Cell Transplantation","enrollment":28},{"nctId":"NCT03765450","phase":"","title":"Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alimentiv Inc.","startDate":"2018-12-21","conditions":"Ulcerative Colitis","enrollment":18},{"nctId":"NCT06954311","phase":"","title":"Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease","status":"RECRUITING","sponsor":"Medical University Innsbruck","startDate":"2025-02-17","conditions":"Ulcerative Colitis (UC), IBD-unclassified (IBD-U)","enrollment":120},{"nctId":"NCT06758024","phase":"NA","title":"PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease","status":"RECRUITING","sponsor":"Pontificia Universidad Catolica de Chile","startDate":"2025-01-24","conditions":"Inflammatory Bowel Disease (IBD), Crohn Disease (CD), Ulcerative Colitis (UC)","enrollment":72},{"nctId":"NCT06051253","phase":"PHASE4","title":"TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease","status":"RECRUITING","sponsor":"Asan Medical Center","startDate":"2023-11-01","conditions":"Crohn Disease, Infliximab, Perianal Fistula Due to Crohn's Disease","enrollment":86},{"nctId":"NCT02134054","phase":"","title":"Stavanger IBD Study - Cross Sectional","status":"UNKNOWN","sponsor":"Helse Stavanger HF","startDate":"2014-04","conditions":"Inflammatory Bowel Disease","enrollment":210},{"nctId":"NCT05280405","phase":"PHASE4","title":"Early Proactive Therapeutic Drug Monitoring of Infliximab in Children: EPIC Study","status":"UNKNOWN","sponsor":"IRCCS Burlo Garofolo","startDate":"2022-03-09","conditions":"Inflammatory Bowel Diseases","enrollment":86},{"nctId":"NCT05986903","phase":"","title":"Influence of HLA-DQA1*05 Genotype in Adults With Anti-TNF Treatment With Proactive Therapeutic Drug Monitoring.","status":"UNKNOWN","sponsor":"Hospital del Rio Hortega","startDate":"2023-01-11","conditions":"Drug Monitoring, Inflammatory Bowel Diseases","enrollment":280},{"nctId":"NCT05825833","phase":"","title":"Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT","status":"COMPLETED","sponsor":"IRCCS Burlo Garofolo","startDate":"2022-03-10","conditions":"Acute Graft-versus-host Disease","enrollment":28},{"nctId":"NCT05379049","phase":"","title":"Therapeutic Response to Tumor Necrosis Factor-alpha (TNF-alpha) Antagonists in Rheumatoid Arthritis.","status":"UNKNOWN","sponsor":"University of Sulaimani","startDate":"2022-03-01","conditions":"Rheumatoid Arthritis, Inflammatory Arthritis, Ankylosing Spondylitis","enrollment":80},{"nctId":"NCT04775732","phase":"PHASE4","title":"Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease","status":"COMPLETED","sponsor":"Imelda GI Clinical Research Center","startDate":"2018-06-01","conditions":"Crohn Disease, Ulcerative Colitis","enrollment":187},{"nctId":"NCT03074656","phase":"NA","title":"The Norwegian Drug Monitoring Study","status":"COMPLETED","sponsor":"Diakonhjemmet Hospital","startDate":"2017-03-01","conditions":"Rheumatoid Arthritis, Spondyloarthritis, Ankylosing Spondylitis","enrollment":611}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"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":"infliximab therapeutic drug monitoring","genericName":"infliximab therapeutic drug monitoring","companyName":"Imelda GI Clinical Research Center","companyId":"imelda-gi-clinical-research-center","modality":"Biologic","firstApprovalDate":"","aiSummary":"Infliximab is a chimeric monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine. Used for Crohn's disease, Ulcerative colitis, Rheumatoid arthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}