Study to investigate the combination of methylprednisolone and interferon-beta in the treatment of multiple sclerosis

Completed

• Conditions: Relapsing-remitting multiple sclerosis; Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN16202527
• Lead Sponsor: Danish Multiple Sclerosis Research Center (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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 Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean number of documented relapses per patient per year at 96 weeks. A documented relapse was defined as the appearance of a new or worsening of old neurological symptoms or signs, in the absence of fever, persisting for more than 48 hours and causing objective changes on neurological examination and preceded by a period of more than 30 days with a stable or improving condition. Changes in bowel and bladder or cerebral functions should not have been solely responsible for a relapse.

Secondary Outcome Measures

Name	Time	Method
1. The mean number of documented relapses per patient per year at 48 weeks<br>2. The occurrence of neutralising antibodies at 96 weeks<br>3. Changes in the Multiple Sclerosis Functional Composite (MSFC) score<br>4. The time to a permanent increase in disability of 1.0 point as measured by the Extended Disability Status Score (EDSS) and confirmed at 2 consecutive visits with an interval of 24 weeks<br>5. The number of active lesions (new or enlarging lesions) on T2 weighted magnetic resonance imaging (MRI)