Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2013
End Date:March 2016

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A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

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.


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
We found this trial at
60
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Clinton Township, Michigan 48038
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Springfield, Massachusetts 01199
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