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

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Biogen

Status and phase

Completed
Phase 4

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

Drug: Interferon-beta-1a (Avonex) plus methylprednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00168766
NOR-03-01
Mecombin

Details and patient eligibility

About

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.

Full 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.

Enrollment

345 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

345 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
interferon-beta-1a in combination with methylprednisolone
Treatment:
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
2
Placebo Comparator group
Description:
interferon-beta-1a in combination with placebo
Treatment:
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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