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NCT00206648 Clinical Trial

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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ABOVE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00206648
Other study ID # 91293
Secondary ID 307245
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated December 30, 2014
Start date March 2003
Est. completion date October 2005

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 271
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Primary Progressive or Secondary Progressive MS

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to onset of first relapse Time to onset of first relapse No
Secondary Number of patients relapse free at week 104 At week 104 No
See also
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Recruiting NCT04002934 - Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis Phase 2
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