9 results
Primary:* To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.Secondary:* To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.* To evaluate the effect of…
Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…
The objective of this study is to assess the effects of an increased NE level on the trade-off between exploitation and exploration. More specifically, this study will compare the exploitative/explorative behavior of participants who received either…
Primary Objectives:- To investigate the effects of a single dose (plasma concentration) 5-HTP challenge test (5-HTP200mg/CBD100+50mg/granisetron2mg) on hypothalamic fMRS activation patterns in healthy male volunteers.Secondary Objectives:- To assess…
Primary:1. To establish the effect of MCP on the release of plasma AVP and subsequent ACTH and cortisol secretion in the absence of a 5HTP-challenge.2. To establish the effect of MCP on the release of plasma AVP and subsequent ACTH and cortisol…
Primary Objective:To evaluate vedolizumab PK in pediatric subjects with UC or CD.Secondary Objectives:* To assess the efficacy of vedolizumab IV in pediatric subjects with UC or CD.* To characterize the dose-response relationship of vedolizumab IV…
Primary Objectives:To evaluate the proportion of subjects with fistula healing at Week 30 with 2 different dose regimens of vedolizumab IV 300 mg in subjects with perianal fistulizing CD.Secondary Objective:To evaluate fistula healing over a 30-week…
Primary Objective:To compare the efficacy of vedolizumab IV and placebo in terms of the percentage of subjects with chronic or recurrent pouchitis achieving clinically relevant remission.Secondary Objectives:To assess the efficacy of vedolizumab IV…
The primary objective of this prospective placebo-controlled study is to assess the ability of vedolizumab to prevent postoperative endoscopic recurrence of Crohn*s disease in the neoterminal ileum.