Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis
- Conditions
- Ulcerative ColitisInflammatory Bowel Diseases
- Registration Number
- NCT06449820
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patient = 18 years old,<br><br> - Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and<br> Colitis Organisation) criteria,<br><br> - Hospitalisation at any point for treatment of ulcerative colitis disease relapse,<br><br> - Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the<br> treatment of severe UC during inpatient stay,<br><br> - Endoscopically confirmed active disease (Mayo endoscopic subscore = 2) within<br> previous four weeks,<br><br> - Patient who has received full information about the organization of the research and<br> who has not objected to his or her participation and to the use of his or her data.<br><br>Exclusion Criteria:<br><br> - Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,<br><br> - Receiving JAKi prior to admission,<br><br> - Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified<br> on admission.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness
- Secondary Outcome Measures
Name Time Method