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

Biogen

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Drug: Interferon beta-1a

Study type

Observational

Funder types

Industry

Identifiers

NCT00599274

C-862

Details and patient eligibility

About

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.

Full 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.

Enrollment

136 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.