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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599274
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : January 27, 2010
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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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1a

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 Type : Observational
Actual Enrollment : 136 participants
Observational Model: Case-Only
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)
Study Start Date : August 2002
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
This group was treated with Avonex once a week
Drug: Interferon beta-1a
injection once a week
Other Name: Avonex

This group was treated with Rebif three times a week
Drug: Interferon beta-1a
injection three times a week
Other Name: Rebif

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599274

United States, California
Research Site
Los Angeles, California, United States
Research Site
Walnut Creek, California, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Massachusetts
Research Site
Worcester, Massachusetts, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Washington
Research Site
Edmonds, Washington, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States
Coordinating Research Site
Woodville, Australia
Coordinating Research Site
Linz, Austria
Canada, Nova Scotia
Coordinating Research Site
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Principal Investigator: Biogen-Idec Investigator Biogen

Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00599274     History of Changes
Other Study ID Numbers: C-862
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: January 2010

Keywords provided by Biogen:
Multiple Sclerosis
Interferon beta 1a

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic