5 results
To assess the safety, reactogenicity, and tolerability of increasing GEM intranasal doses (1.25 mg, 2.5 mg and 5.0 mg) and intramuscular doses (0.05, 0.1, 0.2 mg) of the GEM adjuvant, each administration containing as well a standard 2010/2011 Flu…
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
To determine the effectiveness of the currently recommended treatment regimens.
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…
The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases.The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once…