Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
NCT06660693 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2025-06-22
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.
Conditions
- Colitis, Ulcerative
Interventions
- DRUG
-
Upadacitinib Oral Product
Upadacitinib oral 45mg once daily.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-16
- Primary Completion
- 2027-05-31
- Completion
- 2027-09-30
Countries
- Canada
Study Locations
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