drugset / Trial / NCT01880307
Infliximab Top-down in Pediatric Crohn
Phase 4
Terminated
13 enrolled
Erasmus Medical Center
Universitair Ziekenhuis Brussel · collabUniversity of Roma La Sapienza · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric Crohn's disease (CD) patients.
Timeline
- Start
- 2013-01
- Primary completion
- 2014-12
- Completion
- —
Outcome
Outcome not reported
Stopped: “Not enough study subjects”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | 2 mg/kg | Oral |
| Subject | Azathioprine | Small molecule | 3 mg/kg | Oral |
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Comparator | prednisolon | Unknown | 1 mg/kg | Oral |