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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon-beta-1a (Avonex) plus methylprednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>interferon-beta-1a in combination with methylprednisolone | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone<br>* oral administration given on 3 consecutive days, monthly as described in protocol.<br>* Other names: Avonex;|
| Placebo Comparator: 2<br>interferon-beta-1a in combination with placebo | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone<br>* oral administration given on 3 consecutive days, monthly as described in protocol.<br>* Other names: Avonex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combination therapy for multiple sclerosis