Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:February 2016
End Date:February 2018

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Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)

The purpose of this study is to evaluate the proportion of patients who demonstrate no
medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple
sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based
on real-world data.


Inclusion Criteria:

1. Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple
sclerosis (RRMS).

2. Age between 18 - 55 years at the time of index.

3. No evidence of prior disease modifying therapy for MS.

4. Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is
considered to have initiated treatment if they took at least one dose. Treatment must
have been initiated after the product was approved by the FDA.

5. Availability of a high quality baseline MRI brain scan, which must have occurred
between 6 months prior to the index date to 2 weeks after the index date.

6. Availability of clinical data in the patient's record for the full study observation
period, as defined in the primary objective.

Exclusion Criteria:

1. Pregnant at any time during the study observation period.

2. Presence of pre-existing medical conditions known to be associated with brain
pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol
or substance abuse).

3. Patient discontinued initial therapy prior to completing 1 year of treatment due to a
reason other than disease activity, tolerability, or safety (e.g. financial,
convenience, preference, etc.).

4. Phase III registrational trial patients
We found this trial at
23
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Birmingham, Alabama 35209
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Brighton, Massachusetts 02135
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Buffalo, NY
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Centerville, OH
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Charlotte, North Carolina 28210
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Christiansburg, Virginia 24073
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Colorado Springs, Colorado 80907
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Evanston, Illinois 60201
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Golden Valley, Minnesota 55422
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Lake Success, New York 11042
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Lincoln, Nebraska 68588
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Neenah, Wisconsin 54956
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Raleigh, North Carolina 27607
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Saint Louis, Missouri 63110
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Savannah, Georgia 31406
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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Uniontown, Ohio 44685
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