BridgeMD
New treatment option for Colitis, Ulcerative
Official title Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT06660693
What this study is testing
What is Upadacitinib Oral Product?
Upadacitinib Oral Product is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for colitis, ulcerative.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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...
- Will undergo or has already undergone a baseline colonoscopy or flexible sigmoidoscopy while in hospital or in the 4 weeks preceding trial entry...
- Provided written informed consent
You likely can't join 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...
- Concurrent Clostridium difficile, other gastrointestinal infection, or other active systemic or localized infection which would preclude treatment...
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.