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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2003-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

injection once a week

Intervention Type DRUG

Interferon beta-1a

injection three times a week

Intervention Type DRUG

Other Intervention Names

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Avonex Rebif

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No