How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion Criteria:

• Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy

• Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study

• A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.

• History of seizure in the 3 months prior to randomisation

• History of suicidal ideation or severe depression within the 3 months prior to randomisation.

• Other inclusion and exclusion criteria may apply per study protocol