16 results
The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…
Main study:Primary objective: What are the long-term effects (i.e. after 8-week drug exposure) of the GLP-1RA versus a single dose prandial insulin onrenal hemodynamics (glomerular filtration rate/ effective renal plasma flow in basal insulin-…
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 response 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 remission at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
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…
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).
The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active UC in an 'early' and a 'late' disease…
Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…
Primary Objective: • To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.Secondary Objectives:• To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel…
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 trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target…
To evaluate the efficacy and safety of the Focal C2 CryoBalloon* Ablation System (FCBAS) for the treatment of Barrett*s epithelium.
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 primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target…