Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nancy University Hospital

Vandœuvre-lès-Nancy, Sélectionnez Un Département / État, 54500, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness

Time frame: after study completion, average of 1 month
- 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ATTRACT

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 10, 2024
Registry last updated: May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed