Multiple Sclerosis Clinical Trial
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
Summary
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.
Eligibility Criteria
Key Inclusion Criteria:
Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use Protected Health Information in accordance with national and local patient privacy regulations.
Have the ability to read and understand written English.
Have access to the internet and are able to complete online assessments on a computer
Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI).
Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment.
Have decided to initiate treatment with dimethyl fumarate (DMF) under routine clinical care. The decision to initiate treatment with DMF must precede enrollment.
Have a complete blood count (CBC) available within 6 months of initiation of treatment with dimethyl fumarate (DMF).
Key Exclusion Criteria:
Are unwilling or unable to comply with study requirements, or, are deemed unsuitable for study participation at the discretion of the Prescribing Physician.
Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
Have a history of and/or current serious infections.
Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA).
Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry.
Have received prior treatment with dimethyl fumarate (DMF).
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 62 Locations for this study
Birmingham Alabama, 35209, United States
Tuscon Arizona, 85741, United States
Los Angeles California, 90015, United States
Sacramento California, 95816, United States
San Jose California, 95124, United States
Englewood Colorado, 80113, United States
Dover Delaware, 19901, United States
Jacksonville Florida, 32209, United States
Lighthouse Point Florida, 33064, United States
Port Charlotte Florida, 33952, United States
St. Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30327, United States
Savannah Georgia, 31405, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Franklin Illinois, 37064, United States
Indianapolis Indiana, 46256, United States
Des Moines Iowa, 50314, United States
Lenexa Kansas, 66214, United States
Lexington Kentucky, 40513, United States
Louisville Kentucky, 40207, United States
Baton Rouge Louisiana, 70810, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Lexington Massachusetts, 02421, United States
Springfield Massachusetts, 01104, United States
Worcester Massachusetts, 01655, United States
Clinton Township Michigan, 48035, United States
Muskegon Michigan, 49444, United States
Golden Valley Minnesota, 55422, United States
Columbia Missouri, 65201, United States
Great Falls Montana, 59405, United States
Lincoln Nebraska, 68506, United States
Lincoln Nebraska, 68521, United States
Omaha Nebraska, 68198, United States
Freehold New Jersey, 07728, United States
Bronx New York, 10467, United States
New York New York, 10032, United States
Patchogue New York, 11772, United States
Asheville North Carolina, 28806, United States
Hickory North Carolina, 28602, United States
Raleigh North Carolina, 27607, United States
Akron Ohio, 44302, United States
Canton Ohio, 44718, United States
Centerville Ohio, 45459, United States
Columbus Ohio, 43221, United States
Medford Oregon, 97504, United States
Portland Oregon, 97225, United States
Abington Pennsylvania, 19001, United States
Greensburg Pennsylvania, 15601, United States
Pittsburgh Pennsylvania, 15212, United States
Knoxville Tennessee, 37934, United States
Round Rock Texas, 78681, United States
Salt Lake City Utah, 84103, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23226, United States
Bellingham Washington, 98225, United States
Seattle Washington, 98122, United States
Tacoma Washington, 98405, United States
Neenah Wisconsin, 54946, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.