Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with
      relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and
      Interferon-Beta 1b Trial In Multiple Sclerosis

      Short title: "SWABIMS"

      Study phase: Phase IIb study

      Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland

      Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta

      Reference product: Interferon-beta-1b 250mg given

      Indication: Relapsing-remitting multiple sclerosis (RR-MS)

      Study objectives: Comparison of efficacy, safety and tolerability of combination of
      Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with
      relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d.

      Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.
    

Detailed description: 
      Background

      Multiple sclerosis is considered to be a chronic inflammatory demyelinating 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 seem to 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

      The objectives of this study are 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.

      Methods

      Multi-center, rater-blinded, parallel-group, two arm, randomized study. Patients with
      relapsing-remitting forms of MS, respecting all inclusion/exclusion criteria, will be
      randomized into two equal-size parallel arms after three months of treatment with
      Interferon-beta-1b, receiving Atorvastatin 40mg/d or not. Enrolment of 80 patients (1/2 in
      the Atorvastatin group) is planned. Patients providing written informed consent will be
      treated for 15 months.

      Inclusion criteria: Patients with relapsing-remitting forms of multiple sclerosis with
      disease duration > 3 month and < 5 years, at least 1 relapse in the past two years, > 3
      Lesions on spinal or brain-MRI, EDSS score between 0 and 3.5, inclusive, age between 18 and
      55 years.

      Exclusion criteria: Any disease other than multiple sclerosis that would better explain the
      patient's signs and symptoms, Primary progressive MS, Secondary progressive MS, and others.
    

Intervention name(s): Interferon beta 1b; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Interferon-beta; Atorvastatin; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; interferon beta; atorvastatin