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Footnotes and References
Reference
ADR=adverse drug reaction; AE=adverse event
* 96-week extension study to evaluate the safety and efficacy of cladribine tablets in patients with relapse-remitting multiple sclerosis. The primary objective was safety; efficacy endpoints were exploratory. 806 patients, who had completed the CLARITY study received either a cumulative dose of cladribine tablets 3.5 mg/kg or placebo, with blind maintained.1,3
- MAVENCLAD™ Product Monograph. EMD Serono. November 2017.
- Letter on file. EMD Serono. December 2017.
- Giovannoni G, et al. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: results from the randomized extension trial of the CLARITY study. Mult Scler 2017 [Epub ahead of print].