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 Idec
ClinicalTrials.gov Identifier:
NCT00168766
First received: September 13, 2005
Last updated: September 12, 2013
Last verified: April 2011

September 13, 2005
September 12, 2013
January 2003
November 2008   (final data collection date for primary outcome measure)
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 ]
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 3 months based on change from baseline in EDSS
Complete list of historical versions of study NCT00168766 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing-remitting Multiple Sclerosis
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
Other Name: Avonex
  • Experimental: 1
    interferon-beta-1a in combination with methylprednisolone
    Intervention: Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
  • Placebo Comparator: 2
    interferon-beta-1a in combination with placebo
    Intervention: Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
Ravnborg M, Sørensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholomé E, Constantinescu CS, Beer K, Garde E, Sperling B. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurol. 2010 Jul;9(7):672-80. Epub 2010 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Finland,   Netherlands,   Norway,   Sweden,   Switzerland,   United Kingdom
 
NCT00168766
NOR-03-01, Mecombin
No
Biogen Idec MD, Nordic Medical Director, Biogen Idec International
Biogen Idec
Not Provided
Not Provided
Biogen Idec
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP