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

December 30, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Nepean, Ontario, Canada, K2G 6E2
      • Ottawa, Ontario, Canada, K1H 8L6
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
    • California
      • Berkeley, California, United States, 94705
      • Irvine, California, United States, 92697
      • Loma Linda, California, United States, 92354
      • Los Angeles, California, United States, 90095-1721
      • Sacramento, California, United States, 95817
      • San Jose, California, United States, 95124
      • Walnut Creek, California, United States, 94596
      • Walnut Creek, California, United States, 94598
    • Delaware
      • Wilmington, Delaware, United States, 19806
    • Florida
      • Melbourne, Florida, United States, 32940
      • Miami, Florida, United States, 33136
      • Tampa, Florida, United States, 33609
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
      • Augusta, Georgia, United States, 30912
      • Columbus, Georgia, United States, 31909
      • Savannah, Georgia, United States, 31405
    • Illinois
      • Flossmoor, Illinois, United States, 60422
      • Springfield, Illinois, United States, 62703
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Kansas City, Missouri, United States, 64108
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Reno, Nevada, United States, 89509
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5281
    • New York
      • Albany, New York, United States, 12208
      • Buffalo, New York, United States, 14215
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10003
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Dayton, Ohio, United States, 45409
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Roanoke, Virginia, United States, 24014
    • Washington
      • Seattle, Washington, United States, 98101
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary Progressive or Secondary Progressive MS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Betaferon/Betaseron
Betaseron 250 µg SC every other day
Drug: Betaferon/Betaseron
Avonex 30 µg IM once per week
Experimental: Arm 1
Drug: Betaferon/Betaseron
Betaseron 250 µg SC every other day
Drug: Betaferon/Betaseron
Avonex 30 µg IM once per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to onset of first relapse
Time Frame: Time to onset of first relapse
Time to onset of first relapse

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients relapse free at week 104
Time Frame: At week 104
At week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91293
  • 307245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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