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

Phase 4

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: Interferon-beta-1a (Avonex) plus methylprednisolone

• Registration Number: NCT00168766
• Lead Sponsor: Biogen

Brief 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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2011-04
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Interferon-beta-1a (Avonex) plus methylprednisolone	interferon-beta-1a in combination with methylprednisolone
2	Interferon-beta-1a (Avonex) plus methylprednisolone	interferon-beta-1a in combination with placebo

Primary Outcome Measures

Name	Time	Method
To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS	4 years

Trial Locations

Locations (9)

Kantonspital; 🇨🇭 St. Gallen, Switzerland

CUB Hôpital Erasme; 🇧🇪 Bruxelles, Belgium

Stichting MS Centrum; 🇳🇱 Nijemegen, Netherlands

Neurologkliniken; 🇸🇪 Stockholm, Sweden

Rigshospitalet; 🇩🇰 Skleroseklinikken, Denmark

Coordinating Research Site; 🇩🇰 Copenhagen, Denmark

Tampereen yliopistollinen sairaala - Neurologian klinikka; 🇫🇮 Tampere, Finland

Queens Medical Centre - Division of Neurology; 🇬🇧 Nottingham, United Kingdom

Ullevål Universitetssykehus; 🇳🇴 Oslo, Norway