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

• Status: Withdrawn
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: EMD Serono
• Treatments: Dimethyl Fumarate; Interferon beta-1a

Criteria

Inclusion Criteria:

1. Male and female subjects aged 18-65 years old, inclusive.

2. A diagnosis of MS as defined by the McDonald 2010 criteria for MS.

3. Relapsing form of MS, defined as at least one relapse in the prior 5 years.

4. Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.

5. English language skills adequate for the completion of questionnaires and cognitive measures.

Exclusion Criteria:

1. Subjects with progressive MS.

2. Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease.

3. 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.

4. Subjects with absolute lymphocyte count < 800 cells (mm3).

5. 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;

6. Subjects unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA.

7. 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.

8. 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.

9. History of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.

10. Subjects with abnormal Liver Function Test (LFT) levels