drugset / Trial / NCT02453776
Precision Dosing of Infliximab Versus Conventional Dosing of Infliximab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 10 mg/kg | — |