NORMIMS

Treatment tested

• Methylprednisolone

  Glucocorticoid receptor agonist

• Interferon beta

Other measures (1)

Inclusion: 1. Males and females between the age of 18 and 55 years (both included) 2. Has multiple sclerosis according to the McDonald criteria and suffers from clinically definite relapsing-remitting MS according to the Poser criteria 3. Has a disability equivalent to Expanded Disability Status Scale (EDSS) of 5.5 or less 4. Has been on treatment with IFN-beta-1a (Rebif®) for at least 1 year and has received IFN-beta-1a (Rebif®) 44 µg three times weekly for at least 1 month 5. Has shown clinical activity defined as at least one relapse during the previous 12 months and thereby is classified as a patient with partial treatment response. A historical relapse may be accepted as qualifying as judged by the treating physician. 6. Is prepared to and considered able to follow the protocol during the whole study period and to attend the planned visits 7. Female of childbearing potential must use adequate contraceptive methods and must have negative pregnancy test results 8. Has given written informed consent Exclusion: 1. Has received treatment with lymphoid irradiation, mitoxantrone, cyclophosphamide, or long-term systemic glucocorticoids 2. Has received treatment with azathioprine, cyclosporine, glatiramer acetate, or other immunosuppressive agents or intravenous immunoglobulin within 6 months prior to inclusion in the study 3. Has changed IFN-beta preparation or dose within 3 months of inclusion in the study 4. Has received treatment with systemic glucocorticoids (relapse treatment) or adrenocorticotropic hormone (ACTH) within 8 weeks prior to inclusion in the study 5. Has experienced a relapse within one month prior to the inclusion in the study 6. Has converted to secondary progressive MS 7. Has a history of peptic ulcer or present symptoms of dyspepsia 8. Has suffered from major depression or any other psychiatric disorder that would preclude safe participation in the study 9. Has diabetes mellitus 10. Has alcohol or drug abuse 11. Has cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischaemic heart disease (New York Heart Association [NYHA] Functional Classification III or IV), or malignant hypertension 12. Has renal insufficiency 13. Has aspartate aminotransferase (ASAT) greater than 2.5 x normal upper limit 14. Has leucopenia less than 2500 leucocytes per microlitre or thrombocytopenia less than 100,000 thrombocytes per microlitre 15. Has any medical illness requiring treatment with systemic corticosteroids 16. Has any systemic disease, which can influence his/her safety and compliance, or the evaluation of the disability 17. Has formerly shown severe reactions against corticosteroids 18. Is pregnant or breast-feeding 19. Has epilepsy not under control by anti-epileptic drug (AED)

Not provided at time of registration