UCRecruiting
Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
Phase 3 · Testing Upadacitinib Oral Product · 1 site · McMaster University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Upadacitinib Oral Product (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 64
- Any sex
Some of the main requirements, copied from the record:
- 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:…
- 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
Plus 2 more requirement(s). There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 134 participants are expected to take part.
- Start date: 2025-04-16.
- Main results expected around 2027-05 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Measure treatment success of upadacitinib vs standard care. (16 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative |
| Lead sponsor | McMaster University |
| Collaborators | AbbVie |
| Enrollment | 134 (estimated) |
| Start date | 2025-04-16 |
| Primary completion (est.) | 2027-05 |
| First posted | 2024-10-28 |
| Last updated | 2025-06-22 |
| Official title | Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis: an Open-label Randomized Controlled Trial (RESCUE-UC). |
| ClinicalTrials.gov ID | NCT06660693 |
Interventions
- Upadacitinib Oral Product (Drug)
Upadacitinib oral 45mg once daily.
Full eligibility criteria (from the record)
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 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hamilton Health Sciences | Hamilton, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.