NCT06998797Not yet recruiting
Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 22 May 2025
- Start date
- Jun 2025
- Primary completion date
- Oct 2025
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Ulcerative colitis
- NCT number
- NCT06998797
What you commit to
- Study type: Observational
- Planned participants: 50
- From Jun 2025 to the primary completion date, Oct 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients switched from intravenous to subcutaneous form during follow-up, and who received more than three intravenous perfusions
Other
- Patients with intravenous Infliximab as a maintenance treatment
- Protected persons.
Who the study is looking for
- 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
- 12-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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.