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

NCT ID: NCT00292266

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 677 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2002-06-30

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Relapsing-remitting Multiple Sclerosis; Rebif®; Avonex®; interferon-beta-1a

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rebif®

Group Type: EXPERIMENTAL

Rebif®

Intervention Type: DRUG

Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.

Avonex®

Group Type: ACTIVE_COMPARATOR

Avonex®

Intervention Type: DRUG

Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.

Interventions

Rebif®

Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.

Intervention Type: DRUG

Avonex®

Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono International SA

INDUSTRY

Sponsor Role: collaborator

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordon Francis, M.D.

Role: STUDY_DIRECTOR

Merck Serono International SA

Related Links

http://www.mslifelines.com

Full FDA approved prescribing information can be found here

Other Identifiers

21125

Identifier Type: -

Identifier Source: org_study_id