Actively Recruiting
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
Led by McMaster University · Updated on 2025-06-22
134
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years, male or non-pregnant, non-lactating female
- Confirmed diagnosis of ulcerative colitis by clinical, endoscopic, and/or histologic criteria
- Hospitalized with acute severe flare refractory to at least 3 days of intravenous steroids (minimum 40 mg methylprednisolone daily)
- Refractory defined by Oxford criteria: more than 8 stools per day or CRP over 45 mg/L at day 3 of steroid therapy
- Underwent or will undergo baseline colonoscopy or flexible sigmoidoscopy with Mayo endoscopic score of 2 or higher within 4 weeks before trial entry
- Provided written informed consent
- Willing and able to follow study procedures including screening and safety monitoring per Canadian product guidelines for upadacitinib and infliximab
You will not qualify if you...
- Contraindications to infliximab or upadacitinib according to Canadian product guidelines
- Prior use of infliximab or any JAK inhibitor for ulcerative colitis
- Age over 64 years
- Pregnant or breastfeeding
- Women of reproductive potential unwilling to use effective contraception during treatment and for 4 weeks after last dose of upadacitinib
- Active Clostridium difficile, other GI infection, or systemic/localized infection precluding biologic or small molecule therapy
- Symptoms or confirmed venous or arterial thrombosis
- Active tuberculosis
- Hepatitis B or C positive
- Untreated or ongoing malignancy treatment
- Use of strong CYP3A4 inhibitors or inducers
- Severe liver impairment
- Severe kidney impairment (creatinine clearance under 30 ml/min)
- Received live vaccines in 28 days before study
- Moderate or severe congestive heart failure (NYHA Class III/IV)
- Hypersensitivity to infliximab, murine proteins, excipients, upadacitinib, or formulation components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
Research Team
N
Neeraj Narula
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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