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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206648
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 31, 2014
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Betaferon/Betaseron Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2003
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Time to onset of first relapse [ Time Frame: Time to onset of first relapse ]

Secondary Outcome Measures :
  1. Number of patients relapse free at week 104 [ Time Frame: At week 104 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary Progressive or Secondary Progressive MS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206648

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00206648     History of Changes
Other Study ID Numbers: 91293
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs