Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

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

Details

• Lead Sponsor: Biogen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Informed consent

• Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy

• Disability EDSS score of 4.0 or less at baseline

• Clinical activity as defined by at least one relapse in the last year

Exclusion Criteria:

• Relapse in the month prior to enrolment

• Treatment with immunosuppressive drugs for MS

• History of major depression

• Former severe reactions to corticosteroids

• Pregnant women

• Diabetes mellitus, and drug or alcohol dependency

• Known or suspected allergy to trial products