CompletedNot Applicable

Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis

France36 participantsStarted 2024-04-24

Plain-language summary

Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis. The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient ≥ 18 years old, * Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria, * Hospitalisation at any point for treatment of ulcerative colitis disease relapse, * Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay, * Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks, * Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data. Exclusion Criteria: * Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease, * Receiving JAKi prior to admission, * Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness

Timeframe: after study completion, average of 1 month

Trial details

NCT IDNCT06449820

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Ulcerative Colitis trials