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

Multiple Sclerosis Clinical Trial

— PROOF  

Official title:

A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599274
• Other study ID #: C-862
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: January 26, 2010
• Start date: August 2002
• Est. completion date: May 2003

Study information

• Verified date: January 2010
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: EthikkommissionAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1a
injection once a week
• Interferon beta-1a
injection three times a week

Locations

Country	Name	City	State
Australia	Coordinating Research Site	Woodville
Austria	Coordinating Research Site	Linz
Canada	Coordinating Research Site	Halifax	Nova Scotia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Edmonds	Washington
United States	Research Site	Los Angeles	California
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Walnut Creek	California
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,