Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 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.
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-1b 250 micrograms
- whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more
efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg
Status | Completed |
Enrollment | 2244 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 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 (Interferons), to glatiramer acetate, to human albumin or to mannitol - Pregnancy or lactation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hazard ratio for relapses | During the first and during the second 52 weeks | ||
Secondary | Time to confirmed Expanded Disability Status Score (EDSS) progression | After 52 and after 104 weeks | ||
Secondary | Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images | After 104 weeks |
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