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NCT Number: NCT01111656

Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, Bern University Hospital, and University of Bern

Bern, Canton of Bern, 3007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful completion of the SWABIMS study
  • Written informed consent

Exclusion criteria

  • Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
  • Secondary progressive MS
  • Uncontrolled severe medical disorder
  • Participation in any other studies

Treatment and study plan

Interferon beta-1b group

Drug

Patients receive interferon beta-1b 250ug subcutaneously every other day

Interferon beta-1b/Atorvastatin group

Drug

Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)

Primary outcomes

  1. Proportion of patients with new lesions on T2-weighted images after 12 months of treatment

    Time frame: Month 0

  2. Proportion of patients with new lesions on T2-weighted images after 12 months of treatment

    Time frame: Month 12

Secondary outcomes

  1. Gd-enhancing lesions on T1-weighted images after 12 months of treatment.

    Time frame: Month 0

  2. Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.

    Time frame: Month 0

  3. Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI) after 12 months of treatment

    Time frame: Month 0

  4. Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] )

    Time frame: Month 0

  5. Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )

    Time frame: Month 0

  6. Number of relapse-free patients after 12 months of treatment

    Time frame: Month 0

  7. Relapse rate after 12 months of treatment

    Time frame: Month 0

  8. Time to first relapse

    Time frame: Month 0

  9. Gd-enhancing lesions on T1-weighted images after 12 months of treatment.

    Time frame: Month 12

  10. Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.

    Time frame: Month 12

  11. Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI)after 12 months of treatment

    Time frame: Month 12

  12. Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] )

    Time frame: Month 12

  13. Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )

    Time frame: Month 12

  14. Number of relapse-free patients after 12 months of treatment

    Time frame: Month 12

  15. Relapse rate after 12 months of treatment

    Time frame: Month 12

  16. Time of first relapse

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • PharmaPart
  • Viollier AG, Basel, Switzerland

Registry information

Official study title

SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study")

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2010
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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