2024-517314-15-00Not yet recruitingPhase 4
IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To compare the CIMT after 3 months of therapy in ulcerative colitis in patients treated by anti-TNF, vedolizumab, and tofacitinib
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Aug 2024
- Start date
- 3 Jun 2021
- Lead sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Diseases
- Ulcerative colitis
- EU CT number
- 2024-517314-15-00
- EudraCT number
- 2020-004391-18
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ulcerative colitis who are about to start infliximab, adalimumab, golimumab, vedolizumab or tofacitinib. It looks at how these drugs affect artery thickness.
- Age
- Older than 18 years
- Sex
- Men and women
- Disease stage
- Ulcerative colitis present for at least 6 months
- Earlier treatment
- Must be starting treatment with infliximab, adalimumab, golimumab, vedolizumab or tofacitinib. Blood pressure, antiplatelet or cholesterol drugs must have a stable dose in the 3 months before and during the study.
Main reasons for not taking part
- Heart attack or stroke
- Diabetes
- Pregnant or breastfeeding women
- Not covered by French national health insurance
- Under 18 years old, or deprived of liberty or under guardianship
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period.
Other illness
- Patients with a cardiovascular event such as myocardial infarction and stroke
Other
- Diabetic patient
- Pregnant women or breastfeeding
- Minor
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
Who the study is looking for
- Ulcerative colitis evolving for at least 6 months
- Patient older than 18 years
- Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib
- Patient covered by French national health insurance
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie | Amiens Cedex 1 | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.