drugset / Trial / NCT05043870
Combined Immunosuppression for Pediatric Crohn's Disease
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
Timeline
- Start
- 2022-10-10
- Primary completion
- 2026-10-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | 1 mg/kg | — |
| Subject | Azathioprine | Small molecule | 2 mg/kg | — |
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Methotrexate | Small molecule | 10 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 25 mg/m2 | — |