IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS

IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004391-18-FR

Enrollment

100

Registered

2020-09-14

Start date

2020-10-28

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Interventions

Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion Trade Name: AMGEVITA Product Name: AMGEVITA Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

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 - Patient covered by French national health insurance - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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 or breastfeeding - Minor - -Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the CIMT after 3 months of therapy in UC in patients treated by anti-TNF, vedolizumab, and tofacitinib;Secondary Objective: -To compare the arterial stiffness after 3 months of therapy in UC in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compare the CIMT and arterial stiffness after 12 months of therapy in UC, and the evolution of them, in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compared the biomarkers of endothelial dysfunction and coagulation parameters at baseline and at 3 and 12 months and in patients responders and non-responders in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compared the coagulation parameters at baseline and at 3 and 12 months and in patients’ responders and non-responders to biologics in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compared the levels of neutrophil extracellular traps (NETs) at baseline and at 3 and 12 months and in patients responders and non-responders in patients treated by anti-TNF, vedolizumab, and tofacitinib. ;Primary end point(s): Carotid intima media thickness (CIMT) ;Timepoint(s) of evaluation of this end point: at 12 months	—

Measure

Time frame

Main Objective: To compare the CIMT after 3 months of therapy in UC in patients treated by anti-TNF, vedolizumab, and tofacitinib;Secondary Objective: -To compare the arterial stiffness after 3 months of therapy in UC in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compare the CIMT and arterial stiffness after 12 months of therapy in UC, and the evolution of them, in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compared the biomarkers of endothelial dysfunction and coagulation parameters at baseline and at 3 and 12 months and in patients responders and non-responders in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compared the coagulation parameters at baseline and at 3 and 12 months and in patients’ responders and non-responders to biologics in patients treated by anti-TNF, vedolizumab, and tofacitinib. -To compared the levels of neutrophil extracellular traps (NETs) at baseline and at 3 and 12 months and in patients responders and non-responders in patients treated by anti-TNF, vedolizumab, and tofacitinib. ;Primary end point(s): Carotid intima media thickness (CIMT) ;Timepoint(s) of evaluation of this end point: at 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Aortic pulse wave velocity (aPWV) / arterial stiffness - Augmentation index (AIx) - Framingham score, the 10-year atherosclerotic CV disease risk (ASCVD) indices (reflect of the cardiovascular risk) and the SCORE score - Ulcerative colitis activity score /Mayo Score - Lipids parameters (HDL, LDL, TC, TG) - Arterial tension and systolic pressure index - Endothelial function / Coagulation parameters ;Timepoint(s) of evaluation of this end point: At 12 months	—

Measure

Time frame

Secondary end point(s): - Aortic pulse wave velocity (aPWV) / arterial stiffness - Augmentation index (AIx) - Framingham score, the 10-year atherosclerotic CV disease risk (ASCVD) indices (reflect of the cardiovascular risk) and the SCORE score - Ulcerative colitis activity score /Mayo Score - Lipids parameters (HDL, LDL, TC, TG) - Arterial tension and systolic pressure index - Endothelial function / Coagulation parameters ;Timepoint(s) of evaluation of this end point: At 12 months

—

Countries

France

Contacts

Public ContactPorject manager

CHU Amiens-Picardie

mattoug.salah@chu-amiens.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026