Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study
Observational · No treatment assigned · Sites not listed yet · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2025-06-01 (planned).
- Main results expected around 2025-10-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Treatment failure at 12 months to describe treatment effectiveness (After study completion, average of 1 month)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Central Hospital, Nancy, France |
| Enrollment | 50 (estimated) |
| Start date | 2025-06-01 |
| Primary completion (est.) | 2025-10-01 |
| First posted | 2025-05-31 |
| Last updated | 2025-05-31 |
| Official title | Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study |
| ClinicalTrials.gov ID | NCT06998797 |
Interventions
- Data collection (Other)
Data collection from medical records
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.