6 results
Primary study objective Is the reduction of 1 to several antipsychotic antipsychotic associated with more relapse? Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is defined as: - An absolute increase of> 2 on one of…
Study M16-066 comprises three sub-studies:Sub-study 1: Randomized, double-blind, placebo-controlled maintenanceTo evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active…
Sub-study 1: The objective of sub-study 1 is to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction…
The study is designed to investigate why withdrawal of off-label antipsychotic drugs for behavioral problems in people with intellectual disability often fails by comparing two blinded groups (withdrawa group versus control group). This has led to…
To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease progression / stable disease at or after the week 12 assessment; or death at any time.
In SPACe 2 STAR, we aim to reach further, we will test whether application of TDM in clinical practice is indeed able to reduce the number/severity of metabolic side effects, while retaining clinical effectiveness in children by means of a…