BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Key facts

Study ID

NCT00459667

Run by

Bayer

People needed

1420

Starts

2007-05-01

Expected to finish

2008-03-01

Last updated by the study team

2015-04-23

Who can join

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

You may qualify if…

• Completion of the BEYOND study 306440 as scheduled
• Relapsing multiple sclerosis
• Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
• Females of child-bearing potential:
• Agreement to practice adequate contraception methods and
• Negative pregnancy test and
• No lactation
• Written informed consent

You may not qualify if…

• Serious or acute heart diseases
• History of severe depression or suicide attempt
• Epilepsy not adequately controlled by treatment
• Known allergy to IFNs, to human albumin or to mannitol
• Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

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 — Fort Collins, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Maitland, Florida, 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 — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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