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

Centre Hospitalier Universitaire de Rennes0 个研究点目标入组 150 人开始时间: 2018年7月6日最近更新: 2018年10月10日

适应症

试验速览

暂无简介。

•?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

•?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 ;
•?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

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