drugset / Trial / NCT02453776

Precision Dosing of Infliximab Versus Conventional Dosing of Infliximab

NCT02453776 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with inflammatory bowel disease (IBD). However, a large proportion of patients will eventually lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the outcome of IFX treatment.

Timeline

Start
2015-05
Primary completion
2018-12
Completion
2018-12

Outcome

Met primary endpoint

paper After one year, 28/32 (88%) of patients in the PG were in sustained clinical remission versus 25/39 (64%) in the CG (p = .017). PMID 33290108 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 1 mg/kg —
Subject Infliximab Monoclonal antibody 5 mg/kg —
Subject Infliximab Monoclonal antibody 10 mg/kg —