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

This study has been completed.
Sponsor:
Information provided by:
Biogen
ClinicalTrials.gov Identifier:
NCT00168766
First received: September 13, 2005
Last updated: September 12, 2013
Last verified: April 2011
History of Changes
  Purpose
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 Intervention Phase
Relapsing-remitting Multiple Sclerosis
 Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 345
Study Start Date: January 2003
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168766

Locations
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biogen Idec MD, Nordic Medical Director, Biogen Idec International
ClinicalTrials.gov Identifier: NCT00168766     History of Changes
Obsolete Identifiers: NCT00492180
Other Study ID Numbers: NOR-03-01  Mecombin 
Study First Received: September 13, 2005
Last Updated: September 12, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Biogen:
Combination therapy for multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Methylprednisolone Hemisuccinate
Prednisolone
Interferon-beta
Interferon beta-1a
 Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 23, 2016