drugset / Trial / NCT04629196
Induction Optimization With Stelara for Crohn's Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.
Timeline
- Start
- 2022-02-16
- Primary completion
- 2024-01-17
- Completion
- 2024-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |
| Subject | Ustekinumab | Monoclonal antibody | 260 mg | Intravenous |
| Subject | Ustekinumab | Monoclonal antibody | 390 mg | Intravenous |
| Subject | Ustekinumab | Monoclonal antibody | 520 mg | Intravenous |