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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00206648
First received: September 13, 2005
Last updated: November 7, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: Betaferon/Betaseron
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to onset of first relapse [ Time Frame: Time to onset of first relapse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients relapse free at week 104 [ Time Frame: At week 104 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2003
Study Completion Date: October 2005
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary Progressive or Secondary Progressive MS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206648

  Show 53 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00206648     History of Changes
Other Study ID Numbers: 91293, 307245
Study First Received: September 13, 2005
Last Updated: November 7, 2008
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013