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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00599274
First received: January 11, 2008
Last updated: January 26, 2010
Last verified: January 2010

January 11, 2008
January 26, 2010
August 2002
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Complete list of historical versions of study NCT00599274 on ClinicalTrials.gov Archive Site
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Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis
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.

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.

Observational
Observational Model: Case-Only
Not Provided
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Probability Sample

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

Multiple Sclerosis
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
May 2003
Not Provided

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada
 
NCT00599274
C-862
Yes
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Principal Investigator: Biogen-Idec Investigator Biogen Idec
Biogen Idec
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP