An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis

EMD Serono0 sites677 target enrollmentNovember 1999

ConditionsMultiple Sclerosis, Relapsing-Remitting

InterventionsRebif®Avonex®

DrugsRebif®Avonex®

Overview

Phase: Phase 3
Intervention: Rebif®
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: EMD Serono
Enrollment: 677
Primary Endpoint: Percentage of exacerbation-free subjects
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1999

End Date

June 2002

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EMD Serono

Responsible Party

Sponsor

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)

Arms & Interventions

Rebif®

Intervention: Rebif®

Avonex®

Intervention: Avonex®

Outcomes

Primary Outcomes

Percentage of exacerbation-free subjects

Time Frame: Week 72

Secondary Outcomes

Mean number of combined unique (CU) active lesions per subject per scan(Week 24)
Total exacerbation count per subject(Week 24, 48 and 72)
Mean Number of Time constant 2 (T2) active lesions per subject per scan(Week 24, 48 and 72)