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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00599274

Acronym

PROOF

Enrollment

136

Registered

2008-01-23

Start date

2002-08-31

Completion date

2003-05-31

Last updated

2010-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Interferon beta 1a, Avonex

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.

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.

Interventions

DRUGInterferon beta-1a

injection once a week

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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/

Countries

Australia, Austria, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026