ESTEEM MS Study

Dimethyl Fumarate Observational Study

Condition(s)

  • Multiple sclerosis

Project type

  • Understanding the condition

About the project

The ESTEEM study is a multicenter, global, observational study to collect information on safety and to document the drug utilization of Tecfidera (dimethyl fumarate) when use in routine medical practice in the treatment of multiple sclerosis.

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 adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF).

The 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 on multiple sclerosis disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis relapse information. To assess the effect of dimethyl fumarate on health-related quality of life, healthcare resource consumption, and work productivity.

 

 

 

 

 

 

 

Funder(s)

Biogen

Publication(s)

Status

Closed – analysing data

Contact

Dawn Lyle
dawn.lyle@ed.ac.uk
0131 465 9517

Eligibility criteria

Criteria correct at the time of publication.

Patients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care.

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