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Clinical Trials in France / NCT04743518
Recruiting Phase 4

Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

NCT04743518 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Phase 4
Started
2021-02-02
Last updated
2025-05-29

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Aortic pulse wave velocitycarotid intima media thickness (CIMT)

Aortic pulse wave velocity: Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

carotid intima media thickness (CIMT): carotid intima media thickness (CIMT)

Study summary

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. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • variation of carotid intima media thickness (CIMT) between the 3 patient groups — at the end of month 3

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting

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Other trials for the same condition

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. Active, not recruiting
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) Recruiting
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) Active, not recruiting
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04743518 on ClinicalTrials.gov ↗ ← All trials in France