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

Phase 1

• Conditions: ulcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004391-18-FR
• Lead Sponsor: CHU Amiens-Picardie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-14
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified