Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1a

• Registration Number: NCT00599274
• Lead Sponsor: Biogen

Brief Summary

The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.

Detailed Description

This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.

Study Timeline

• Study Start: 2002-08
• Study Completion: 2003-05
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Must have been receiving AVONEX® or Rebif®.
• Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria.
• Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment.
• Must have an EDSS score of 0.0 to 5.5, inclusive.

Exclusion Criteria

• History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation.
• History of poorly controlled hypertension and/or other clinically significant major disease.
• History of uncontrolled seizures within the 3 months prior to enrollment.
• History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment.
• Serious local infection or systemic infection within 8 weeks prior to enrollment.
• Treatment with certain other agents to treat MS symptoms or underlying disease.
• Treatment with any investigational product
• Previous participation in this study.
• Other Protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Interferon beta-1a	This group was treated with Avonex once a week
B	Interferon beta-1a	This group was treated with Rebif three times a week

Trial Locations

Locations (2)

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States

Coordinating Research Site; 🇨🇦 Halifax, Nova Scotia, Canada