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

• Status: Recruiting
• Trial end date: 2024-01-04
• Target enrollment: 0
• Participant gender: All

Summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades.

However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up.

Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue.

Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Infliximab; Vedolizumab

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