NCT01930708

A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes

A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,114 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period. The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.

Conditions

• Relapsing-Remitting Multiple Sclerosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	Administered as per the approved dosage in all countries where DMF has received marketing authorization.

Timeline

• Start date: 2013-10-31
• Primary completion: 2016-03-31
• Completion: 2020-01-09
• First posted: 2013-08-29
• Last updated: 2020-03-19

Locations

90 sites across 11 countries: Austria, Belgium, Canada, Czechia, France, Hungary, Italy, Portugal, Slovakia, Slovenia, Spain