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

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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

Key facts

Study ID

NCT00099502

Run by

Bayer

People needed

2244

Starts

2003-11-01

Expected to finish

2007-08-01

Last updated by the study team

2008-12-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Cullman, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Berkeley, California, United States
• Study site — La Jolla, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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