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

Recruiting Phase 3 Interventional Study
Colitis, Ulcerative
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
134 (estimated)
Sponsor
McMaster University · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 steroi…
Contacts

Neeraj Narula

905-521-2011

neeraj.narula@medportal.ca

CONTACT