EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

Launched by RENNES UNIVERSITY HOSPITAL · Sep 19, 2018

Keywords

ClinConnect Summary

The EFFICACI trial is studying how well two different treatments work for patients with ulcerative colitis (UC) who haven’t had enough success with their current medication, specifically anti-TNF treatments like adalimumab or golimumab. The trial compares intravenous infliximab, a type of anti-TNF medication, to vedolizumab, a newer treatment that works differently by targeting the gut's inflammation. This research aims to find out which treatment is more effective for patients who are not responding well to their previous therapy.

To participate in this trial, individuals need to be 18 to 74 years old, have a confirmed diagnosis of UC for at least six months, and show moderate to severe disease symptoms despite ongoing anti-TNF treatment for at least 12 weeks. Participants must also provide written consent to join. Throughout the study, participants will receive either infliximab or vedolizumab, and the goal is to determine the best approach for managing their UC. It’s important to note that there are specific criteria that would exclude some people from participating, such as certain health conditions or previous treatments.

Gender

ALL

Eligibility criteria

• 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 Janus kinase inhibitor (JAK inhibitor) ;
• • Affiliation to the national health insurance.
• Non inclusion 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