A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: Avonex®

Drug: Rebif®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00292266

21125

Details and patient eligibility

About

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.

Enrollment

677 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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)