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NOT YET RECRUITING
NCT06998797

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

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-06-01

Completion Date

2025-10-01

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

OTHER

Data collection

Data collection from medical records