7 results
(voor meer details zie CMO-protocol paragraaf 2: Objectives) Primary Objective: The objective of this project is to further refine N-of-1 trial methodology, and explore whether Bayesian analysis of multiple N-of-1 trials can serve as a sufficient…
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…
The purpose of this study is to find out how well JNJ-56021927 works when it is given along with abiraterone acetate and prednisone to treat prostate cancer. The safety of JNJ-56021927 when used with abiraterone acetate will also be studied. How…
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…
primaryTo assess the safety and tolerability of multiple, once-daily oral doses of RDN-929 over 28 days in healthy older adult subjects and early symptomatic AD subjects.secondaryTo assess the plasma and CSF pharmacokinetics (PK) of RDN-929 in…
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.
The main aim is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours after trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and ARDS) within 30 days (combined…