drugset / Trial / NCT05928039
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
RandomizedParallel-groupSingle-blindTreatment
Summary
There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \[TNF\] alpha, anti-integrin, and anti-interleukin \[IL\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year. Endoscopic remission means that the ulcers in the small bowel from Crohn's disease have healed. All treatments in this trial are approved by Health Canada. No experimental drugs will be included.
Timeline
- Start
- 2023-10-25
- Primary completion
- 2027-07-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Comparator | Risankizumab | Monoclonal antibody | 360 mg | Intravenous |
| Comparator | Ustekinumab | Monoclonal antibody | 90 mg | Intravenous |
| Comparator | Vedolizumab | Monoclonal antibody | 108 mg | Intravenous |
| Comparator | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |