Relapsing-remitting Multiple Sclerosis Clinical Trial
Official title:
SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study")
The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.
Background
Multiple sclerosis is a chronic inflammatory autoimmune disease of the central nervous
system. Statins are lipid-lowering drugs which inhibit the
3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA-) reductase, which is the main regulatory
enzyme of cholesterol biosynthesis. In recent years many studies have demonstrated, that
statins have anti-inflammatory and immunomodulatory properties in addition to their
lipid-lowering effects. Therefore, statins may have therapeutic potential in immune-mediated
disorders such as multiple sclerosis. Studies in experimental allergic encephalomyelitis
(EAE), the animal model for the human demyelinating disease multiple sclerosis, as well as
smaller studies in patients with relapsing-remitting multiple sclerosis showed beneficial
effect on the course of the disease. But there are also reports of negative impact of
statins on multiple sclerosis. Therefore, bigger studies are needed to investigate the
therapeutical potential of statins in multiple sclerosis.
Objective
To assess the efficacy, safety and tolerability of the combination of atorvastatin 40mg p.o.
daily and interferon-beta 1b sc e.o.d compared to monotherapy with interferon-beta-1b sc
e.o.d in patients with relapsing-remitting multiple sclerosis for 12 month after completing
the SWABIMS study.
Methods
Multi-center, rater-blinded, parallel-group, two arm, randomized study. Patients with
relapsing-remitting forms of MS, respecting all inclusion/exclusion criteria, were
randomized in the SWABIMS study in two equal-size parallel arms after three months of
treatment with interferon-beta 1b, receiving atorvastatin 40mg/d or not in addition to
interferon-beta 1b for 12 month.
After successful completion of the study, patients were asked to participate in the "SWABIMS
Follow up study" for another 12 month with ongoing medication.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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