NCT05722353Active, not recruiting
IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic diseases characterized by relapsing and remitting episodes. About comparator strategies/procedures Infliximab in its Intravenous (IV) form was the first biotherapy to be approved to treat IBD. Biosimilars of intravenous (IV) infliximab have been shown to be non-inferior to the reference product in patients with IBD, to induce and maintain clinical response Recently, the subcutaneous (SC) formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 (CT-P13 IV). These results were based on 66 patients treated with CT-P13 SC, and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Aug 2022
- Start date
- 13 Feb 2023
- Primary completion date
- Nov 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05722353
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 13 Feb 2023 to the primary completion date, Nov 2025
- 1 site in 1 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
- Previous exposure to infliximab: originator or biosimilars
Other
- Patients not eligible to infliximab according to standard of care screening
- Participation in another interventional study
- No coverage by the French health insurance
Who the study is looking for
- Diagnosis of Crohn's disease or ulcerative colitis (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
- Starting infliximab as standard of care (originator or biosimilars)
- with or without concomitant immunosuppressive agent and/or steroids use at infliximab initiation
- Patients agreeing to participate
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Antoine Hospital Service de Gastroentérologie et Nutrition Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.