Saturday, June 28, 2014

Gastrointestinal Tolerability Study Of Tecfidera In Participants With Relapsing-Remitting Multiple Sclerosis:

The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by subjects with relapsing-remitting multiple sclerosis initiating therapy with Tecfidera (dimethyl fumarate, DMF, BG00012) in the clinical practice setting.

The secondary objectives of this study in this study population are as follows: To evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; To evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with Tecfidera dose modification; and To evaluate gastrointestinal-related events that lead to Tecfidera discontinuation after the use of symptomatic therapy.

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