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)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46164
• EU PAS number:
  EUPAS6782
• Study ID:
  46164
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Canada

  Denmark

  France

  Germany

  Hungary

  Ireland

  Italy

  Netherlands

  New Zealand

  Norway

  Poland

  Portugal

  Puerto Rico

  Slovakia

  Spain

  Switzerland

  United Kingdom

  United States
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 468 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/12/2013

Actual: 04/06/2013

Study start date

Planned: 31/12/2013

Actual: 19/11/2013

Date of final study report

Planned: 30/11/2024

Actual: 21/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

109MS401 Protocol V3 (EU) Final 15Aug14_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

109MS401 https://clinicaltrials.gov/ct2/show/NCT02047097?term=109ms401&rank=1