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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06449820
Other study ID # 2024PI030
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 30, 2024
Est. completion date June 30, 2024

Study information

Verified date June 2024
Source Central Hospital, Nancy, France
Contact Laurent PEYRIN-BIROULET, MD, PhD
Phone 0383153661
Email peyrinbiroulet@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
France Nancy University Hospital Vandoeuvre-les-Nancy Sélectionnez Un Département / État

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness Absence of steroid-free clinical remission according to the PRO-2 (stool =1 and rectal bleeding sub-score of 0)
Use of a prohibited treatment for relapse (partial Mayo score >5)
Severe adverse event leading to discontinuation of JAKi treatment
Colectomy
Death during the study period
after study completion, average of 1 month
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