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

January 26, 2010 updated by: Biogen

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
This group was treated with Avonex once a week
Drug: Interferon beta-1a
injection once a week
Other Names:
  • Avonex
Drug: Interferon beta-1a
injection three times a week
Other Names:
  • Rebif
B
This group was treated with Rebif three times a week
Drug: Interferon beta-1a
injection once a week
Other Names:
  • Avonex
Drug: Interferon beta-1a
injection three times a week
Other Names:
  • Rebif

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Principal Investigator: Biogen-Idec Investigator, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-862

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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