Clinical Trial:

ESTEEM Study

Full Name

MULTIPLE SCLEROSIS/ 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 (2_PRO00002507)

Description

This is an observational research study of an oral medicine called Tecfidera™ (dimethyl fumarate). Your participation in this study is expected to last 5 years. This research study will collect the following information: Your age, gender race, and ethnicity (as permitted by local laws); the date you started Tecfidera and the recommended dosage; your medical history, including cardiovascular risk factors; the duration on Tecfidera or primary reason for any discontinuation; prior and current use of any MS treatments; your MS disease history (type of MS, relapse history, etc.); pregnancy status for women of childbearing potential; laboratory tests as per routine clinical practice; any serious side effects you may experience; any other side effects that might lead to treatment discontinuation; MS relapse; and your opinion on your quality of life. To learn your opinion on your quality of life and obtain information about any hospital or doctor visits you make, you will be asked to complete 6 self-administered questionnaires. It will take approximately 35-40 minutes to complete the questionnaires, and they will be available online. If you are unable to complete the questionnaires online, you may complete the questionnaires in your doctor’s office. Online questionnaires must be completed within 1 week before or after your scheduled visit.

Eligibility

Inclusion Criteria
Inclusion Criteria-including but may not be limited to:
  • Must have MS
  • Must have been newly prescribed DMF (dimethyl fumarate/ Tecfidera™) under routine clinical care
  • Patients with previous exposure to DMF, Fumaderm®, and compounded fumarates are excluded