Relapsing-remitting Multiple Sclerosis
Conditions
Keywords
Combination therapy for multiple sclerosis
Brief summary
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
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.
Interventions
DRUGInterferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Belgium, Denmark, Finland, Netherlands, Norway, Sweden, Switzerland, United Kingdom
Outcome results
None listed