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

Completed

Conditions studied: Relapsing-remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02823951

Run by

IMS HEALTH GmbH & Co. OHG

People needed

479

Starts

2016-02-01

Expected to finish

2018-02-01

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
• Age between 18 - 55 years at the time of index.
• No evidence of prior disease modifying therapy for MS.
• 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.
• 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.
• Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.

You may not qualify if…

• Pregnant at any time during the study observation period.
• Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
• 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.).
• Phase III registrational trial patients

Where it is running

• Alabama Neurology Associates — Birmingham, Alabama, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Savannah Neurology Specialists — Savannah, Georgia, United States
• Northshore University — Evanston, Illinois, United States
• OSF Multi-specialty Group d/b/a Illinois Neurological Institute — Peoria, Illinois, United States
• St Elizabeths/ Dragonfly Research — Brighton, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
• Washington university — St Louis, Missouri, United States
• University of Nebraska Medical Center — Lincoln, Nebraska, United States
• University of Buffalo Clinical and Translational research Center — Buffalo, New York, United States
• Neurological Associates of Long Island — Lake Success, New York, United States
• Onsite Clinical Solutions — Charlotte, North Carolina, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• Dayton Center for Neurological Disorders — Centerville, Ohio, United States
• Oak Clinic-Multiple Sclerosis — Uniontown, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• The university of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Vermont — Burlington, Vermont, United States
• Blacksburg Neurology — Christiansburg, Virginia, United States
• MultiCare Health System — Tacoma, Washington, United States
• Neuroscience Group — Neenah, Wisconsin, United States
• Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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