Ulcerative ColitisPhase 4VASC-UCNCT04743518
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
A Phase 4 study testing Aortic pulse wave velocity and carotid intima media thickness (CIMT) in people with Ulcerative Colitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Aortic pulse wave velocity and carotid intima media thickness (CIMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Mathurin Fumery, Pr, 03 22 08 88 51, Fumery.mathurin@chu-amiens.fr
Marie-Antoinette Sevestre, Pr
About this study
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Aortic pulse wave velocity, carotid intima media thickness (CIMT)
- Keywords
- ulcerative colitis, cardiovascular risk, CIMT
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic pulse wave velocityOther
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
carotid intima media thickness (CIMT)Other
carotid intima media thickness (CIMT)
| Study group | Role | What they receive |
|---|---|---|
| anti-TNF | Active comparator | Not described Receives: Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT) |
| vedolizumab | Active comparator | Not described Receives: Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT) |
| tofacitinib | Active comparator | Not described Receives: Other: Aortic pulse wave velocity; Other: carotid intima media thickness (CIMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of carotid intima media thickness (CIMT) between the 3 patient groups
Measured: at the end of month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start2 Feb 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743518
- Sponsor's protocol ID
- PI2020_843_0114
- Acronym
- VASC-UC
- Status last verified
- May 2025
- First submitted
- 3 Feb 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- VASC-UC / PI2020_843_0114
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, cardiovascular risk, CIMT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anti-TNF | Active comparator | Other: Aortic pulse wave velocity, Other: carotid intima media thickness (CIMT) |
| vedolizumab | Active comparator | Other: Aortic pulse wave velocity, Other: carotid intima media thickness (CIMT) |
| tofacitinib | Active comparator | Other: Aortic pulse wave velocity, Other: carotid intima media thickness (CIMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic pulse wave velocityAortic pulse wave velocity (aPWV) is a measure of aortic stiffness | Other | anti-TNF, tofacitinib, vedolizumab |
| carotid intima media thickness (CIMT)carotid intima media thickness (CIMT) | Other | anti-TNF, tofacitinib, vedolizumab |
Primary outcome
variation of carotid intima media thickness (CIMT) between the 3 patient groups
Time frame: at the end of month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aortic pulse wave velocity and carotid intima media thickness (CIMT) in people with Ulcerative Colitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathurin Fumery, Pr (03 22 08 88 51, Fumery.mathurin@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of carotid intima media thickness (CIMT) between the 3 patient groups (time frame: at the end of month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.