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

Biogen345 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

345

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

Interferon-beta-1a (Avonex) plus methylprednisoloneDRUG

oral administration given on 3 consecutive days, monthly as described in protocol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (9)

CUB Hôpital Erasme

Brussels, Belgium

Coordinating Research Site

Copenhagen, Denmark

Rigshospitalet

Skleroseklinikken, Denmark

Tampereen yliopistollinen sairaala - Neurologian klinikka

Tampere, Finland

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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