Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Phase 4 · Testing Aortic pulse wave velocity and carotid intima media thickness (CIMT) · 1 site · Centre Hospitalier Universitaire, Amiens
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Aortic pulse wave velocity and carotid intima media thickness (CIMT) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Ulcerative colitis evolving for at least 6 months,
- Patient older than 18 years,
- Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2021-02-02.
- Main results expected around 2025-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- variation of carotid intima media thickness (CIMT) between the 3 patient groups (at the end of month 3)
In the researchers’ words
An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown.
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 | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
| Enrollment | 100 (estimated) |
| Start date | 2021-02-02 |
| Primary completion (est.) | 2025-12 |
| First posted | 2021-02-08 |
| Last updated | 2025-05-29 |
| Official title | Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT04743518 |
Interventions
- Aortic pulse wave velocity (Other)
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness - carotid intima media thickness (CIMT) (Other)
carotid intima media thickness (CIMT)
Full eligibility criteria (from the record)
Inclusion Criteria: * Ulcerative colitis evolving for at least 6 months, * Patient older than 18 years, * Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib, * Written informed consent. Exclusion Criteria: * Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period, * Patients with a cardiovascular event such as myocardial infarction and stroke, * Diabetic patient, * Pregnant women, * Minor * people unable to give their consent to participate
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens | Amiens | France | Recruiting |
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.