EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.

Phase 1

• Conditions: lcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2018-002673-21-FR
• Lead Sponsor: Centre Hospitalier Universitaire de Rennes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Last Update Posted: 10 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

?Male or non-pregnant female, non-lactating female;
?18 years of age or older and less than 75 years ;
?Documented diagnosis of UC for at least 6 months ;
?Left side colitis or pancolitis ;
?Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ;
?Active disease despite ongoing treatment with adalimumab or golimumab for at least 12 weeks (inadequate response, failure, loss of response or intolerance) ;
?Ability of the subject to participate fully in all aspects of this clinical trial ;
?Written informed consent must be obtained and documented ;
?Naïve to JAK inhibitor ;
?Affiliation to the national health insurance.

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

?Contraindication to continue TNF antagonist (ongoing abscess(es), clinical suspicion of tuberculosis, past allergic reaction) ;
?Contraindication to vedolizumab treatment ;
?Steroid treatment > 20 mg/day for at least two weeks before baseline ;
?Proctitis ;
?Stoma ;
?Proctocolectomy or subtotal colectomy ;
?Planned surgery within the year of the trial ;
?Previous exposure to vedolizumab or infliximab ;
?History of cancer during the past 5 years ;
?Pregnancy or breastfeeding
?Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
?Ongoing participation to another interventional study

Study & Design

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