Dimethyl Fumarate (DMF) Observational Study



Status:Recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 30, 2013
End Date:February 28, 2024
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)

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.

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.

Key Inclusion Criteria:

- Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl
fumarate (DMF) under routine clinical care are eligible to participate in the study.

Key Exclusion Criteria:

- Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid
esters), or compounded fumarates.

- Patients participating in other clinical studies.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
127
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