Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— ATTRACT  

Official title:

Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449820
• Other study ID #: 2024PI030
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

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