NCT00168766

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

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Interferon-beta-1a (Avonex) plus methylprednisolone	oral administration given on 3 consecutive days, monthly as described in protocol.

Timeline

• Start date: 2003-01-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2005-09-15
• Last updated: 2013-09-16

Locations

9 sites across 8 countries: Belgium, Denmark, Finland, Netherlands, Norway, Sweden, Switzerland, United Kingdom