a study of rebif® compared with avonex® in the treatment of relapsing-remitting multiple sclerosis (ms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (ms). the primary objective is to demonstrate the superiority of rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of avonex® 30 mcg intramuscular injection given once a week.


Eligibility criteria:
inclusion criteria: * age between 18 and 55 years * clinically definite or laboratory-supported definite relapsing-remitting ms according to poser's criteria * two or more relapses within the preceding 24 months * clinical stability or improving neurological state during the 4 weeks before study day 1 * expanded disability status scale (edss) score from 0 to 5.5, inclusive * two or more lesions consistent with ms on a screening proton density/t2-magnetic resonance imaging (mri) scan to be performed 28 plus/minus (+/-) 4 days before the study day 1 mri * willingness and ability to comply with the protocol for the duration of the study * written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care * for female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hcg) pregnancy test within 7 days of study day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized) exclusion criteria: * secondary progressive ms, primary progressive ms or progressive relapsing ms * prior use of interferon * treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (acth) within 4 weeks of study day 1 or within 7 days before the screening mri * psychiatric disorder that is unstable or will preclude safe participation in the study * significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of study day 1 * elevated liver function tests (alanine transaminase \[alt\], aspartate transaminase \[ast\], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of study day 1 * prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before study day 1 * immunomodulatory or immunosuppressive therapy within the 12 months before study day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone * previous use of cladribine or total lymphoid irradiation * allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (dtpa) * intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before study day 1 * systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (hiv) or human t-cell lymphotrophic virus, type-1 (htlv-1)

Keywords: relapsing-remitting multiple sclerosis rebif® avonex® interferon-beta-1a