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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 7, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Time to onset of first relapse [ Time Frame: Time to onset of first relapse ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Time to onset of first relapse

Change History

Complete list of historical versions of study NCT00206648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Number of patients relapse free at week 104

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: Betaferon/Betaseron
Betaseron 250 µg SC every other day
Drug: Betaferon/Betaseron
Avonex 30 µg IM once per week

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Betaferon/Betaseron
Active Comparator: Arm 2
Intervention: Drug: Betaferon/Betaseron

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

October 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Primary Progressive or Secondary Progressive MS

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00206648

Other Study ID Numbers ^ICMJE

91293, 307245

Has Data Monitoring Committee

Yes

Responsible Party

Medical Affairs Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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