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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

333

Study ID:

NCT01903291

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 62 Locations for this study

See Locations Near You

Research Site
Birmingham Alabama, 35209, United States
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Tuscon Arizona, 85741, United States
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Los Angeles California, 90015, United States
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Sacramento California, 95816, United States
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San Jose California, 95124, United States
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Englewood Colorado, 80113, United States
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Dover Delaware, 19901, United States
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Jacksonville Florida, 32209, United States
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Lighthouse Point Florida, 33064, United States
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Port Charlotte Florida, 33952, United States
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St. Petersburg Florida, 33705, United States
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Tampa Florida, 33612, United States
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Atlanta Georgia, 30309, United States
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Atlanta Georgia, 30327, United States
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Savannah Georgia, 31405, United States
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Chicago Illinois, 60637, United States
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Evanston Illinois, 60201, United States
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Franklin Illinois, 37064, United States
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Indianapolis Indiana, 46256, United States
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Des Moines Iowa, 50314, United States
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Lenexa Kansas, 66214, United States
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Lexington Kentucky, 40513, United States
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Louisville Kentucky, 40207, United States
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Baton Rouge Louisiana, 70810, United States
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Annapolis Maryland, 21401, United States
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Baltimore Maryland, 21201, United States
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Lexington Massachusetts, 02421, United States
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Springfield Massachusetts, 01104, United States
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Worcester Massachusetts, 01655, United States
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Clinton Township Michigan, 48035, United States
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Muskegon Michigan, 49444, United States
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Golden Valley Minnesota, 55422, United States
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Columbia Missouri, 65201, United States
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Great Falls Montana, 59405, United States
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Lincoln Nebraska, 68506, United States
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Lincoln Nebraska, 68521, United States
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Omaha Nebraska, 68198, United States
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Freehold New Jersey, 07728, United States
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Bronx New York, 10467, United States
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New York New York, 10032, United States
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Patchogue New York, 11772, United States
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Asheville North Carolina, 28806, United States
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Hickory North Carolina, 28602, United States
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Raleigh North Carolina, 27607, United States
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Akron Ohio, 44302, United States
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Canton Ohio, 44718, United States
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Centerville Ohio, 45459, United States
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Columbus Ohio, 43221, United States
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Medford Oregon, 97504, United States
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Portland Oregon, 97225, United States
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Abington Pennsylvania, 19001, United States
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Greensburg Pennsylvania, 15601, United States
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Pittsburgh Pennsylvania, 15212, United States
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Knoxville Tennessee, 37934, United States
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Round Rock Texas, 78681, United States
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Salt Lake City Utah, 84103, United States
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Norfolk Virginia, 23502, United States
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Richmond Virginia, 23226, United States
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Bellingham Washington, 98225, United States
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Seattle Washington, 98122, United States
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Tacoma Washington, 98405, United States
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Neenah Wisconsin, 54946, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

333

Study ID:

NCT01903291

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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