Last updated on November 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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 ;
  • Nave 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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