7 results
The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease who have failed or are intolerant to one or more tumor…
The primary safety objective of this investigation is to assess the safety of long-term LES electrical stimulation therapy in patients with GERD.The primary functionality objective of this study is to evaluate the ability of the device to initiate…
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-…
To evaluate the safety and efficacy of long term stimulation of the lower esophageal sphincter in patients with gastroesophageal reflux disease after sleeve gastrectomy.
The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…
The primary objective is to evaluate the achievement of clinical response at Week 16 following a single IV re-induction dose of *6 mg/kg ustekinumab, compared with continuing regular SC q8w 90 mg ustekinumab administration, in participants with…
Primary Objectives:- To estimate complete response rate, per pathology review committee (PRC), and its duration in CIS participantsSecondary Objectives:- To evaluate progression free survival, per pathologie review committee (PRC), for all…