Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)



Status:Active, not recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:1/14/2017
Start Date:May 2016
End Date:May 2017

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A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)

The primary objective of the study is to evaluate the real-world clinical effectiveness, as
measured by the proportion of participants relapsed at 12 months, in participants treated
with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as
measured by the proportion of participants relapsed at 12 months, in participants treated
with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall
participant cohort and in a subset of participants who were naïve to disease-modifying
therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the
index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among
participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related
hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To
compare intravenous corticosteroid use among participants treated with DMF, GA,
teriflunomide, or fingolimod.


Key Inclusion Criteria:

- Diagnosis of RRMS per McDonald criteria

- Initiated treatment with DMF, GA, teriflunomide, or fingolimod (defined as index
therapy) no earlier than January 2011 and no later than 12 months prior to the date
of medical record abstraction (i.e., patient has at least 12 months of data available
in the medical record following initiation of index treatment). Note: Patients who
have initiated the index therapy but subsequently discontinued or switched to other
therapies are allowed in this study as long as there is at least 12 months of
follow-up following the initiation of the index therapy.

- Have sufficient available medical records for data abstraction to meet the objectives
of the study, i.e., the patient was either under the medical care of the
investigating site during the entire period of the index treatment or the patient's
complete MS disease and treatment history is otherwise available at the investigating
site

Key Exclusion Criteria:

- Diagnosis of a progressive form of MS (progressive relapsing, primary progressive,
secondary progressive) at any time before or during the period for which data will be
collected

- Have received disease-modifying therapies other than one platform therapy (IFN or GA)
prior to initiation of index therapy. In patients for whom GA is index therapy, only
one prior IFN therapy is allowed.

- Have received any formulations of DMF, Fumaderm®, or compounded fumarates (e.g.,
Psorinovo) at any time prior to initiation of treatment with Tecfidera®

- Concurrent enrollment in any interventional clinical trial of an investigational
product during time evaluated for medical record abstraction

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
37
sites
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Jacksonville, FL
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Amherst, NY
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Avon, IN
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Boston, MA
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Ciudad Autónoma de Buenos Aires, Buenos Aires
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Ciudad Autónoma de Buenos Aires,
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Cleveland, OH
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Columbus, OH
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Danbury, CT
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Franklin, IN
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Gilbert, AZ
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Golden Valley, MN
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Hanford, CA
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Hartford, CT
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Homewood, AL
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Houston, TX
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Mansfield, TX
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Medford, OR
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Modesto, CA
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Muncie, IN
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Norfolk, VA
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Overland Park, KS
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Patchogue, NY
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Philadelphia, PA
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Port Orange, FL
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Portland, OR
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Raleigh, NC
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Round Rock, TX
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Savannah, GA
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Tacoma, WA
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Wellesley, MA
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