BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Glatiramer Acetate; Interferon beta-1b; Interferon-beta; Interferons

Criteria

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