NCT06449820Completed
Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis
Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study
Source: ClinicalTrials.gov · Last updated 6 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 36 (actual)
- First submitted
- 15 Apr 2024
- Start date
- 24 Apr 2024
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Ulcerative colitis
- NCT number
- NCT06449820
What you commit to
- Study type: Observational
- Participants enrolled: 36
- From 24 Apr 2024 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving JAKi prior to admission,
Other illness
- Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,
- Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nancy University Hospital Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.