An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS

NCT ID: NCT00206648

Last Updated: 2014-12-31

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

Clinical Phase

PHASE4

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-10-31

Brief Summary

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The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.

Detailed Description

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This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Betaferon/Betaseron

Intervention Type DRUG

Betaseron 250 µg SC every other day

Arm 2

Group Type ACTIVE_COMPARATOR

Betaferon/Betaseron

Intervention Type DRUG

Avonex 30 µg IM once per week

Interventions

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Betaferon/Betaseron

Betaseron 250 µg SC every other day

Intervention Type DRUG

Betaferon/Betaseron

Avonex 30 µg IM once per week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* RRMS patients that are receiving treatment with Avonex 30 µg once weekly

Exclusion Criteria

* Primary Progressive or Secondary Progressive MS
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Tucson, Arizona, United States

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Berkeley, California, United States

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Irvine, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Jose, California, United States

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Walnut Creek, California, United States

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Walnut Creek, California, United States

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Wilmington, Delaware, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Flossmoor, Illinois, United States

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Springfield, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Golden Valley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Reno, Nevada, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Buffalo, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Roanoke, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Nepean, Ontario, Canada

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Ottawa, Ontario, Canada

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Countries

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United States Canada

Other Identifiers

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307245

Identifier Type: -

Identifier Source: secondary_id

91293

Identifier Type: -

Identifier Source: org_study_id