Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS

Withdrawn before enrolling

Conditions studied: Multiple Sclerosis

In brief

To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.

Key facts

Study ID

NCT02419638

Run by

Brigham and Women's Hospital

People needed

0

Starts

2015-05-01

Expected to finish

2016-02-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects aged 18-65 years old, inclusive.
• A diagnosis of MS as defined by the McDonald 2010 criteria for MS.
• Relapsing form of MS, defined as at least one relapse in the prior 5 years.
• Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
• English language skills adequate for the completion of questionnaires and cognitive measures.

You may not qualify if…

• Subjects with progressive MS.
• Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease.
• Subjects treated with:
• High dose intravenous immunoglobulin within 2 months prior to study entry
• Natalizumab within 3 months prior to study entry
• Immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
• Subjects with absolute lymphocyte count < 800 cells (mm3).
• Subjects with any of the following neurologic/psychiatric disorder:
• Severe depression during the past 12 months before screening;
• History of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
• Subjects unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA.
• Pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test.
• Female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
• History of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
• Subjects with abnormal Liver Function Test (LFT) levels

Where it is running

• Partners MS Center, 1 Brookline Place Suite 225 — Brookline, Massachusetts, United States

Full record on ClinicalTrials.gov

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