Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Interferon beta-1b group; Interferon beta-1b/Atorvastatin group
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive interferon beta-1b 250ug subcutaneously every other day; Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
Intervention MeSH terms: Interferons; Interferon-beta; Atorvastatin; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multi-center; randomized; prospective; parallel-group; rater-blinded; RR-MS