NCT00099502CompletedPhase 3
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 2,244
- Primary Endpoint
- Hazard ratio for relapses
Study Overview
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-1b 250 micrograms
- whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg
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 Schering Pharma AG, Germany.
Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Experimental
Intervention: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
Arm 2
Experimental
Intervention: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
Arm 3
Active Comparator
Intervention: Copaxone (Drug)
Outcomes
Primary Outcomes
Hazard ratio for relapses
Time Frame: During the first and during the second 52 weeks
Secondary Outcomes
- Time to confirmed Expanded Disability Status Score (EDSS) progression(After 52 and after 104 weeks)
- Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images(After 104 weeks)
Investigators
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