drugset / Trial / NCT00554710
Top Down Versus Step Up Strategies in Crohn's Disease
Phase 4
Completed
129 enrolled
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Centocor, Inc. · collabSchering-Plough · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.
Timeline
- Start
- 2001-05
- Primary completion
- —
- Completion
- 2004-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | 2 mg/kg | — |
| Subject | Azathioprine | Small molecule | 2 mg | — |
| Subject | Azathioprine | Small molecule | 2.5 mg/kg | — |
| Subject | Azathioprine | Small molecule | 2.5 mg | — |
| Comparator | Budesonide | Small molecule | 9 mg | — |
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 32 mg | — |
| Comparator | Methylprednisolone | Other / unclassified | 64 mg | — |