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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00168766
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 16, 2013
Sponsor:
Information provided by:
Biogen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Interferon-beta-1a (Avonex) plus methylprednisolone Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2003
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Avonex


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168766


Locations
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Belgium
CUB Hôpital Erasme
Bruxelles, Belgium
Denmark
Coordinating Research Site
Copenhagen, Denmark
Rigshospitalet
Skleroseklinikken, Denmark
Finland
Tampereen yliopistollinen sairaala - Neurologian klinikka
Tampere, Finland
Netherlands
Stichting MS Centrum
Nijemegen, Netherlands
Norway
Ullevål Universitetssykehus
Oslo, Norway
Sweden
Neurologkliniken
Stockholm, Sweden
Switzerland
Kantonspital
St. Gallen, Switzerland
United Kingdom
Queens Medical Centre - Division of Neurology
Nottingham, United Kingdom, Ng72uh
Sponsors and Collaborators
Biogen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biogen Idec MD, Nordic Medical Director, Biogen Idec International
ClinicalTrials.gov Identifier: NCT00168766    
Obsolete Identifiers: NCT00492180
Other Study ID Numbers: NOR-03-01
Mecombin
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: April 2011
Keywords provided by Biogen:
Combination therapy for multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Methylprednisolone
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Immunologic Factors
Adjuvants, Immunologic