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

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.

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.

subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.

• Drug: Interferon beta-1a
  injection once a week
  Other Name: Avonex
• Drug: Interferon beta-1a
  injection three times a week
  Other Name: Rebif

• A
  This group was treated with Avonex once a week
  Intervention: Drug: Interferon beta-1a
• B
  This group was treated with Rebif three times a week
  Intervention: Drug: Interferon beta-1a

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.