Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe
This study aims to examine patients with acute severe UC who are refractory to intravenous corticosteroids and determine whether a strategy of using upadacitinib first followed by infliximab in upadacitinib non-responders is non-inferior to conventional management with infliximab only.
| Condition(s) | Colitis, Ulcerative |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study aims to examine patients with acute severe UC who are refractory to intravenous corticosteroids and determine whether a strategy of using upadacitinib first followed by infliximab in upadacitinib non-responders is non-inferior to conventional management with infliximab only. |
| Who can participate | Inclusion Criteria: Adult (≥ 18 - 64 years) male or non-pregnant, non-lactating female patients with: * Confirmed diagnosis of UC, based on conventional clinical, endoscopic, and/or histologic criteria * Admitted to hospital with acute severe flare and refractory to three days of intravenous steroids (at minimum of 40mg methylprednisolone, or equivalent, daily). Refractory is defined using the Oxford criteria at day 3 of steroid therapy: presence of \> 8 stools/day or CRP \> 45 mg/L * Will undergo or has already undergone a baseline colonoscopy or flexible sigmoidoscopy while in hospital or in the 4 weeks preceding trial entry, with a baseline MES ≥2 based on locally evaluated endoscopy * Provided written informed consent * Subject is willing and able to adhere to study procedures, and des |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Lead sponsor | McMaster University |
| Locations | Hamilton, Ontario, Canada |
| Start date | 2025-04-16 |
| NCT ID | NCT06660693 |
| Official listing | https://clinicaltrials.gov/study/NCT06660693 |