drugset / Trial / NCT01559142
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy: 1. Infliximab with immunomodulation 2. Infliximab alone
Timeline
- Start
- 2008-11
- Primary completion
- 2012-04
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 1.5 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 3 mg/kg | — |
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |