Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
Recruiting now · Phase 3
Conditions studied: Colitis, Ulcerative
In brief
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 facts
- Study ID
- NCT06660693
- Run by
- McMaster University
- People needed
- 134
- Starts
- 2025-04-16
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-06-22
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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 treatment with systemically acting biologic or small molecule therapy
- Patients with symptoms of thrombosis, or confirmed venous or arterial thromboembolism
- Active TB (patients should be tested for TB prior to upadacitinib or infliximab treatment)
- HBV/HCV positive
- Untreated malignancy or ongoing treatment for malignancy
- Concomitant treatment with strong CYP3A4 inhibitors or inducers
- Severe hepatic impairment
- Severe renal impairment (CrCl < 30 ml/min)
- Patients who have received live vaccines in the 28 days prior to study entry.
- Patients with moderate or severe (NYHA Class III/IV) congestive heart failure.
- Patients with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients.
- Patients who are hypersensitive to upadacitinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Where it is running
- Hamilton Health Sciences — Hamilton, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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