CombiRX – determine whether combined treatment with interferon beta-1a (INF-b) IM once weekly and glatiramer acetate (GA) SQ daily is more effective than either agent alone in treating RR MS, as determined by reduction in relapse rate
Inclusion Criteria:
· Between ages 18 and 60 years
· Diagnosis of Relapsing-Remitting MS
· Expanded Disability Status Scale (EDSS) score between 0 and 5.5
· At least 2 exacerbations in the last 3 years
· Able to give written consent
Exclusion Criteria:
· Any prior use of interferon beta (Betaseron®) or glatiramer acetate (Copaxone®)
· Acute exacerbations within 30 days of study entrance or chronic systemic steroid use
· Evidence of progressive MS
· Use of IVIg, CellCept or plasma exchange in the last twelve weeks prior to study drug dosing
· Any previous treatment with Tysabri, Cladribine, T cell vaccine, Daclizumab or total lymphoid irradiation
· Unable to undergo MRI scan
· Unable to perform baseline MSFC (Timed 25-Foot Walk, 9-hole Peg Test, PASAT3)
· History of any significant cardiac, hepatic, pulmonary or renal disease; immune deficiency
· History of suicidal ideation or an episode of severe depression within 3 months prior to randomization
· History of alcohol or drug abuse within 2 years prior to randomization
· Female subjects, except postmenopausal or surgically sterile, unwilling to practice effective birth control method
Active and Enrolling
Contact: Nancy Lawlor
336 7161704
nlawlor@wfubmc.edu