An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-Remitting MS - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206648

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 IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta 1a Interferon beta-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Arm 1: Experimental	Drug: Betaferon/Betaseron Betaseron 250 µg SC every other day
Arm 2: Active Comparator	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

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

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon-beta
Interferon beta-1b

Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009