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

Sponsor
Central Hospital, Nancy, France
Study ID
NCT06998797
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Data collection — OTHER
    Data collection from medical records

Study Details

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.

Key Dates

First listed
May 31, 2025
Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Global cohort

Primary Outcome Measure

Treatment failure at 12 months to describe treatment effectiveness [ Time Frame: After study completion, average of 1 month ]

Central Contacts

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