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

NCT ID: NCT04743518

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anti-TNF

Group Type ACTIVE_COMPARATOR

Aortic pulse wave velocity

Intervention Type OTHER

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

carotid intima media thickness (CIMT)

Intervention Type OTHER

carotid intima media thickness (CIMT)

vedolizumab

Group Type ACTIVE_COMPARATOR

Aortic pulse wave velocity

Intervention Type OTHER

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

carotid intima media thickness (CIMT)

Intervention Type OTHER

carotid intima media thickness (CIMT)

tofacitinib

Group Type ACTIVE_COMPARATOR

Aortic pulse wave velocity

Intervention Type OTHER

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

carotid intima media thickness (CIMT)

Intervention Type OTHER

carotid intima media thickness (CIMT)

Interventions

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Aortic pulse wave velocity

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

Intervention Type OTHER

carotid intima media thickness (CIMT)

carotid intima media thickness (CIMT)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathurin Fumery, Pr

Role: CONTACT

03 22 08 88 51

Facility Contacts

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Mathurin Fumery, Pr

Role: primary

03 22 08 88 51

Other Identifiers

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PI2020_843_0114

Identifier Type: -

Identifier Source: org_study_id

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