Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerat… (NCT06660693) | Clinical Trial Compass
RecruitingPhase 3
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
Canada134 participantsStarted 2025-04-16
Plain-language 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
Age range18 Years – 64 Years
SexALL
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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 describe in the procedures that screening and safety monitoring procedures will be applied as per upadacitinib and infliximab Canadian product monographs
Exclusion Criteria:
* Contraindications to receiving either infliximab or upadacitinib (as per current Canadian product monograph)
* Previously used infliximab or a JAK inhibitor for UC
* Patients \> 65 years of age
* Pregnant or breastfeeding
* Women of reproductive potential who are unwilling to agree to using effective contraception during treatment and 4 weeks following the final dose of upadacitinib
* Concurrent Clostridium difficile, other gastrointestinal infection, or other active systemic or localized infection which would preclude…
What they're measuring
1
Measure treatment success of upadacitinib vs standard care.