Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis

Sponsor
McMaster University
Study ID
NCT06660693
Phase
PHASE3
Status
Recruiting
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Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Jun 2025
Primary completion
May 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Upadacitinib (treatment arm)
    Participants will receive Upadacitinib 45mg daily, once a day, for at least five days.
  • No Intervention: Infliximab (standard care)
    Participants will receive standard care, which is Infliximab.

Primary Outcome Measure

Measure treatment success of upadacitinib vs standard care. [ Time Frame: 16 weeks ]

Central Contacts

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