A Study of the Safety and Use of Tecfidera in Routine Medical Practice for the Treatment of Multiple Sclerosis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- La Crosse, Wisconsin: 14-004026
NCT ID: NCT02047097
Sponsor Protocol Number: 109MS401
About this study
The purpose of this study is to better identify the long term benefit to risk profile of tecfidera in patients with multiple sclerosis who are prescribed tecfidera under routine clinical care.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Have multiple sclerosis (MS)
- Are newly initiating treatment with tecfidera (dimethyl fumarate) under routine clinical care
- Other protocol defined inclusion criteria may apply
Exclusion Criteria
- Previous exposure to dimethyl fumarate (DMF), fumaderm (fumaric acid esters), or compounded fumarates
- Are participating in other clinical studies
- Other protocol defined exclusion criteria may apply
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
La Crosse, Wis.
Mayo Clinic principal investigator Gregory Pupillo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available