12 results
Primary Objective• To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFa) antagonist therapy (TNFa subpopulation)Secondary…
Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical response at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
See protocol page 19The primary objective is to determine the occurrence of post-operative AT/AF between the start of anesthesia and the first 5 days after CABG surgery in randomized groups, defined as patients in the SCS group and patient in the…
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…
This study will evaluate the safety, efficacy, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe ulcerative colitis (UC).
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 sponsor is developing a compound (PB016) similar to Entyvio® (vedolizumab, hereafter referred to as Entyvio). As part of medical-scientific studies to confirm the similarity of the biological products, the sponsor wants to compare PB016 with EU-…
Our explorative pilot study wants to observe whether TDM can attribute to an efficient dose de-escalation strategy of SC vedolizumab in patients with IBD in order to reduce costs. In this study we will compare costs and clinical efficiency of TDM-…
The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…
Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…
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.