BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose
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: Betaseron/Betaferon 250mcg, Betaseron/Betaferon 500mcg and Copaxone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Clinical Research Center, Study Director, Affiliation: clinical-trials-contact@bayerhealthcare.com
Summary
The purpose of this study is to determine
1. whether treatment with interferon beta-1b 500 micrograms safe, tolerable and more
efficacious than treatment with interferon beta-1b 250 micrograms
2. whether treatment with interferon beta-1b tolerable and more efficacious than treatment
with Copaxone 20 mg
Clinical Details
Official title: International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Hazard ratio for relapses
Secondary outcome: Time to confirmed EDSS progressionMRI: Change from screening in volume of hypointense lesion on enhanced T1 weighted images
Detailed description:
Number of arms: 3
(Male and female RRMS patients will be randomized to one of three parallel treatment groups:
Interferon beta-1b 500 μg, Interferon beta-1b 250 μg, Copaxone 20 mg)
This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc.
has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been
renamed to Bayer Schering Pharma AG, Germany.
Bayer HealthCare Pharmaceuticals, Inc. and Bayer Schering Pharma AG, Germany are the sponsors
of the trial.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Female and male patients; aged 18-55 years; diagnosis of RRMS, EDSS score of 0 to 5. 0;
treatment-naïve to IFNB or Copaxone
Exclusion Criteria:
Neurological progression at disease onset or between relapses, serious or acute heart
diseases, history of severe depression or suicide attempt, serious or acute liver, renal or
bone marrow dysfunction, monoclonal gammopathy, known allergy to Gadolinium-DTPA, to IFNs,
to glatiramer acetate, to human albumin or to mannitol, pregnancy or lactation
Locations and Contacts
Additional Information
This study is the same study protocol as NCT00185432, with different locations. Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product
Starting date: November 2003
Last updated: June 28, 2007
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