Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study

NCT06998797 | Not Yet Recruiting

• 1 other identifier: 2025PI032
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Around 25% of patients with ulcerative colitis will develop acute severe colitis during the course of their disease. The first-line treatment for acute severe colitis is intravenous corticosteroid therapy. In case of a cortico-resistant form, treatment with intravenous (ciclosporin or Infliximab is indicated), according to European guidelines. The emergence of biosimilar in the last years is a turning point in a context of optimizing healthcare costs and improving patient quality of life, with the arrival of the subcutaneous form of Infliximab in 2020, with similar results in terms of clinical remission, but also blood levels of Infliximab compared with the intravenous form. To our knowledge, there are very few data on the use of subcutaneous Infliximab after intravenous induction in patients with acute severe colitis. The aim of this study is to evaluate the efficacy of subcutaneous Infliximab in ulcerative colitis patients with acute severe colitis, and the factors associated with treatment failure.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Treatment failure at 12 months to describe treatment effectiveness

  Absence of steroid free clinical remission (Mayo score ≤2, with every sub-score ≤1) or absence of endoscopic response (Mayo endoscopic sub-score ≤1) or use of a rescue treatment if relapse (other than Infliximab) or occurrence of a severe adverse event with withdrawal of treatment or colectomy or death during follow-up

  After study completion, average of 1 month

Study Arms (1)

Global cohort

Other: Data collection

Interventions

Data collection OTHER

Data collection from medical records

Global cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in acute severe ulcerative colitis treated with subcutaneous Infliximab

You may qualify if:

• Patient ≥ 18 years old
• Diagnosis of acute severe ulcerative colitis according to Truelove Witts criteria
• Patients treated with at least one injection of subcutaneous Infliximab after induction with two or three intravenous perfusions of Infliximab
• Patients with a follow-up of at least 12 months after the first subcutaneous injection
• month data available in medical records
• 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.

You may not qualify if:

• Patients with intravenous Infliximab as a maintenance treatment
• Patients switched from intravenous to subcutaneous form during follow-up, and who received more than three intravenous perfusions
• Protected persons.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Bénédicte CARON, MD, PhD

CONTACT

+33383155580; b.caron@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05