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

NCT00292266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 677

Last updated 2013-08-05

No results posted yet for this study

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

Interventions

DRUG

Rebif®

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

DRUG

Avonex®

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

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • EMD Serono

    lead INDUSTRY

Principal Investigators

  • Gordon Francis, M.D. · Merck Serono International SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Primary Completion
2002-06-30
Completion
2002-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00292266 on ClinicalTrials.gov