Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Gastrointestinal event
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 214
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) 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 BG00012 dose modification; and to evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy.

Detailed description:

Arms:
arm 1: Dimethyl fumarate administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.

Interventions: intervention 1: dimethyl fumarate
Intervention descriptions: intervention 1: capsules administered according to the prevailing product label

Protocol document: