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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:
ClinicalTrials.gov Identifier:
NCT00206648
First Posted: September 21, 2005
Last Update Posted: December 31, 2014
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.
Information provided by (Responsible Party):
Bayer
  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
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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

Enrollment: 271
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00206648


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00206648     History of Changes
Other Study ID Numbers: 91293
307245
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 31, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Sclerosis
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