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)

J
Jaison Grimes, MD

Primary Investigator

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

This study is being done to gain a better understanding of the benefits and risks of long-term treatment with Tecfidera in patients with multiple sclerosis (MS). The main purpose of this observational study is to collect information on any serious side effects that may occur in patients taking Tecfidera (for example, serious infections, liver and kidney problems, cancers, and any other serious side effects). Information on relapses, disability progression, and the quality of life in patients taking Tecfidera will also be collected.

Detailed description of study

The purpose of this study is to better characterize the long-term benefit-risk profile of Dimethyl fumarate (DMF) in patients with multiple sclerosis (MS) who are prescribed DMF under routine clinical care.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: multiple sclerosis
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Patients with MS who have been newly prescribed DMF under routine clinical care are eligible to participate in the study.
Patients must be naive to DMF, Fumaderm and compounded fumarates at the time of enrollment, but need not be naive to other MS treatments, and must not be currently enrolled in any other clinical trial or study except for the DMF Pregnancy Registry or other studies that, according to the study Medical Director, do not conflict with the observational study (e.g., health economic studies)
Exclusion Criteria
Patients with previous exposure to DMF, Fumaderm, and compounded fumarates
Patients participating in other clinical studies


Additional Information:

Updated on 01 Aug 2024. Study ID: 1708876471

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