An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-Remitting MS
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting
Intervention: Interferon Beta-1b (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Berlex, Inc. Medical Affairs, Study Director, Affiliation: 1-888-BERLEX4
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.
Clinical Details
Official title: A Randomized, Rater-Blinded, Multicenter, Parallel-Group Study Comparing the Efficacy and Safety of Betaseron 250 Mcg Subcutaneously Every Other Day With Avonex 30 Mcg Intramuscularly Once Per Week in Relapsing-Remitting Multiple Sclerosis Patients Previously Treated With Avonex
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to onset of first relapse
Secondary outcome: Number of patients relapse free at week 104
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- RRMS patients that are receiving treatment with Avonex 30ug once weekly.
Exclusion Criteria:
- Primary Progressive or Secondary Progressive MS
Locations and Contacts
Additional Information
Starting date: March 2003
Last updated: April 30, 2007
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