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

September 12, 2013 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • CUB Hôpital Erasme
  • Denmark
      • Copenhagen, Denmark
        • Coordinating Research Site
      • Skleroseklinikken, Denmark
        • Rigshospitalet
  • Finland
      • Tampere, Finland
        • Tampereen yliopistollinen sairaala - Neurologian klinikka
  • Netherlands
      • Nijemegen, Netherlands
        • Stichting MS Centrum
  • Norway
      • Oslo, Norway
        • Ulleval Universitetssykehus
  • Sweden
      • Stockholm, Sweden
        • Neurologkliniken
  • Switzerland
      • St. Gallen, Switzerland
        • Kantonspital
  • United Kingdom
      • Nottingham, United Kingdom, Ng72uh
        • Queens Medical Centre - Division of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
interferon-beta-1a in combination with methylprednisolone
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
Other Names:
  • Avonex
Placebo Comparator: 2
interferon-beta-1a in combination with placebo
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
Other Names:
  • Avonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOR-03-01
  • Mecombin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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