Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis

NCT ID: NCT06449820

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2024-12-30

Brief 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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Dr Laurent PEYRIN-BIROULET

Principal Investigator / Scientific responsible

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nancy University Hospital

Vandœuvre-lès-Nancy, Sélectionnez Un Département / État, France

Countries

France

Other Identifiers

2024PI030

Identifier Type: -

Identifier Source: org_study_id