6 results
The goal of this study is to prove that there is a benefit in terms of post-operative outcome not only because of the multi-modal improvements in peri-operative fluid management through the ERAS program, but also by the use of a goal-directed fluid…
The primary objective is to obtain post-market clinical data according to the requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section 3 of Annex IV, Section…
The main reason for this study is to help in answering the following research question: - Whether mirikizumab can help patients with Crohn*s disease when taken for a longer time. - How safe mirikizumab is and whether you might have any side effects…
Primary for Platform-Level Exploratory Analysis1. To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in achieving clinical remission and endoscopic response in pediatric participants with moderately to severely active…
MAIN Trial:Primary:To evaluate whether the efficacy of mirikizumab is superior to placebo in participants with Crohn's disease as assessed by- clinical response by patient reported outcome (PRO) at Week 12 andendoscopic response at Week 52-…
Study AMAP is a single-arm, outpatient, open-label, Phase 3, multicenter, long-term extension study evaluating the efficacy and safety of mirikizumab in patients with moderately to severely active UC who have participated in an originator…