Dimethyl Fumarate (DMF) Observational Study

  • STATUS
    Not Recruiting
  • End date
    Feb 28, 2024
  • participants needed
    5600
  • sponsor
    Biogen
Updated on 26 May 2021
Investigator
Biogen
Primary Contact
Research Site (3.6 mi away) Contact
+378 other location
cancer
dimethyl fumarate

Summary

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

Description

Patients aged 12 to under 18 may be included where enrollment of pediatric patients in this study is considered observational and is permissible by local regulations.

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave
Treatment dimethyl fumarate
Clinical Study IdentifierNCT02047097
SponsorBiogen
Last Modified on26 May 2021

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