9 results
Primary objectives:- to assess the safety and tolerability of bolus doses of ABP-700 in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- to optimize bolus dosing of ABP-700 in combination with pre-…
Primary objectives:- To assess the safety and tolerability of intravenous (IV) infusion doses and infusion dosing methodologies of ABP-700 alone or in the presence of pre-medications commonly used in the monitored anesthesia care (MAC) setting.- To…
To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…
Answering the following questions:1. Main question: Is remifentanil a usefull medication for PSA in the emergency department?2. What is the recovery time of the patient when using fentanyl / propofol / remifentanil (time between last gift PSA…
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.
Primary Objective:• To evaluate the safety and tolerability of danavorexton single IV infusion administered in healthy subjects undergoing OIRD.Secondary Objective:• To assess the PK of danavorexton single IV infusion administered in healthy…
The aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…