NCT01903291

Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 333 (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) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.

Conditions

• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	As described in the treatment arm

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2013-07-19
• Last updated: 2016-07-25

Locations

62 sites across 1 country: United States