Relapsing Remitting Multiple Sclerosis (MS) Nervous System Diseases Multiple sclerosis (MS)
Conditions
Interventions
Interventions are standard interferon beta-1a therapy plus randomisation to either monthly oral methylprednisolone pulsed therapy (1.5 g/month) or matching placebo
Sponsors
Biogen Idec
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/05/2008: 1. Informed consent 2. Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy 3. Extended Disability Status Scale (EDSS) score of 4.0 or less at baseline 4. Clinical activity as defined by at least one relapse in the last year Previous inclusion criteria: Adult subjects aged 18-55 with relapsing remitting MS, previously untreated with immunomodulatory drugs.
Exclusion criteria
Exclusion criteria: Exclusion criteria added as of 21/05/2008: 1. Relapse in the month prior to enrolment 2. Treatment with immunosuppressive drugs for MS 3. History of major depression 4. Former severe reactions to corticosteroids 5. Pregnant women 6. Diabetes mellitus, and drug or alcohol dependency 7. Known or suspected allergy to trial products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 21/05/2008: 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 randomisation in EDSS (Time Frame: 4 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Belgium, Denmark, Finland, Netherlands, Norway, Sweden, Switzerland, United Kingdom
Outcome results
None listed