5 results
Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…
The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…
Comparison of steady-state cysteamine-trough WBC cystine levels between Cystagon® and RP103 over 3 months for each treatment period.
Primary objective: To investigate the effectiveness of ongoing treatment with methylphenidate as prescribed in clinical practice beyond two years in children and adolescents. Secondary objectives:(1) to investigate the effects of discontinuation of…
To establish the pharmacokinetic profiles of saliva and plasma concentration of 10 mg MPH-IR and 18 mg MPH-OROS in healthy volunteers; to investigate whether there is a correlation between saliva- and plasma levels of MPH-IR and MPH-OROS, and if…