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 |
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.
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
sites
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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
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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Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
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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