Status:
COMPLETED
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine * whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1...
Detailed Description
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 S...
Eligibility Criteria
Inclusion
- Female and male patients
- Aged 18-55 years
- Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
- Treatment-naive to IFNB or Copaxone
Exclusion
- 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 (Interferons), to glatiramer acetate, to human albumin or to mannitol
- Pregnancy or lactation
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
2244 Patients enrolled
Trial Details
Trial ID
NCT00099502
Start Date
November 1 2003
End Date
August 1 2007
Last Update
December 19 2008
Active Locations (199)
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1
Birmingham, Alabama, United States, 35294
2
Cullman, Alabama, United States, 35058
3
Phoenix, Arizona, United States, 85013
4
Tucson, Arizona, United States, 85741-3537