BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Betaseron/Betaferon 250mcg, Betaseron/Betaferon 500mcg and Copaxone (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs, Study Director, Affiliation: +49 30 468 11800

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

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: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Hazard ratio for relapses

Secondary outcome:

Time to confirmed EDSS progression

MRI: Change from screening in volume of hypointense lesion on enhanced T1 weighted images after 104 weeks

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

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

This study is the same study protocol as NCT00099502, with different locations.

Starting date: November 2003
Last updated: April 30, 2007