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OpenTrials
Completed

NCT Number: NCT00599274

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Coordinating Research Site, Woodville, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon beta-1a

Drug

injection once a week

Other names: Avonex

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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)

Acronym: PROOF

Important dates

Study start
2002
Study completion
2003
First posted
Jan 23, 2008
Registry last updated
Jan 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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