Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis: an Open-label Randomized Controlled Trial (RESCUE-UC). (RESCUE UC)

NCT06660693 Phase 3 RECRUITING

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.

Details

Lead sponsor	McMaster University
Phase	Phase 3
Status	RECRUITING
Enrolment	134
Start date	2025-04-16
Completion	2027-09

Conditions

• Colitis, Ulcerative

Interventions

• Upadacitinib Oral Product

Primary outcomes

• Measure treatment success of upadacitinib vs standard care. — 16 weeks
  The primary objective of this study is to evaluate whether treatment success in ASUC patients in patients treated with strategy U is non-inferior to strategy C after 16 weeks of initiating therapeutic management.

Countries

Canada