Comparison of Vedolizumab treatment to Adalimumab dose intensification in Crohn’s disease patients with loss of response or biomarker activity to Adalimumab on first line with therapeutic drug concentration: A randomized, multicentre, controlled VEDIAN trial.

Crohn's disease

The primary objective will be to compare the proportion of clinical and biomarker remission (composite score) in the two groups of CD patients by 24 weeks after inclusion (ADA optimized versus Vedolizumab as second line).

Compare deep remission defined as clinical remission (clinical activity score < 150 with fecal calprotectin < 250 mcg/g stools and CRP < 5mg/L and either CDEIS <3 using ileocolonoscopy or Lewis score < 135 in the small bowel using VCE or no disease activity on MRE (defined by segmental Maria score < 7) or no bowel thickness on US according to the previous tools used at inclusion at W24., Compare treatment failure at W24 or W52 in the 2 groups, Compare the percentage of adverse events in both arms at W52, Symptomatic remission at W24 is a composite criterion measured by PRO2 defined as: Stool frequency (SF) < 3 with abdominal pain score (AP) < 2 at W24; AND absence of therapeutic failure between inclusion and W24., Compare evolution of IBDQ-32 in the two groups of patients between inclusion and W24, Compare rates of clinical and biomarker remission at W12, Compare rates of clinical and biomarker remission at W52, rate of Mucosal remission at W24, Analyze the CDST (clinical decision support tool) score for prediction of remission under vedolizumab and adalimumab optimization.

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