NCT00292266

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 1999-11-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2006-02-15
• Last updated: 2013-08-05