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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Betaferon/Betaseron (Drug); Betaferon/Betaseron (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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.

Clinical Details

Official title: A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to onset of first relapse

Secondary outcome: Number of patients relapse free at week 104

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Primary Progressive or Secondary Progressive MS

Locations and Contacts

Tucson, Arizona 85741, United States

Berkeley, California 94705, United States

Irvine, California 92697, United States

Loma Linda, California 92354, United States

Los Angeles, California 90095-1721, United States

Sacramento, California 95817, United States

San Jose, California 95124, United States

Walnut Creek, California 94596, United States

Walnut Creek, California 94598, United States

Wilmington, Delaware 19806, United States

Melbourne, Florida 32940, United States

Miami, Florida 33136, United States

Tampa, Florida 33606, United States

Tampa, Florida 33609, United States

Atlanta, Georgia 30309-1465, United States

Augusta, Georgia 30912, United States

Columbus, Georgia 31909, United States

Savannah, Georgia 31405, United States

Flossmoor, Illinois 60422, United States

Springfield, Illinois 62703, United States

Fort Wayne, Indiana 46805, United States

Indianapolis, Indiana 46202, United States

Des Moines, Iowa 50314, United States

Kansas City, Kansas 66160, United States

Shreveport, Louisiana 71130, United States

Baltimore, Maryland 21201, United States

Detroit, Michigan 48201, United States

Golden Valley, Minnesota 55422, United States

Minneapolis, Minnesota 55455, United States

Rochester, Minnesota 55905, United States

Kansas City, Missouri 64108, United States

St. Louis, Missouri 63110, United States

Reno, Nevada 89509, United States

Albuquerque, New Mexico 87131-5281, United States

Albany, New York 12208, United States

Buffalo, New York 14215, United States

Mineola, New York 11501, United States

New York, New York 10003, United States

Asheville, North Carolina 28801, United States

Winston-Salem, North Carolina 27157, United States

Dayton, Ohio 45409, United States

Oklahoma City, Oklahoma 73120, United States

Nepean, Ontario K2G 6E2, Canada

Ottawa, Ontario K1H 8L6, Canada

Medford, Oregon 97504, United States

Philadelphia, Pennsylvania 19104, United States

Providence, Rhode Island 02905, United States

Charleston, South Carolina 29425, United States

Houston, Texas 77030, United States

Fairfax, Virginia 22031, United States

Roanoke, Virginia 24014, United States

Seattle, Washington 98101, United States

Tacoma, Washington 98405, United States

Additional Information

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Click here to find results for studies related to Bayer Healthcare products.

Starting date: March 2003
Last updated: December 30, 2014

Page last updated: August 20, 2015

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