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

September 6, 2011 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3007
        • Department of Neurology, Bern University Hospital, and University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Interferon beta-1b 250ug subcutaneously every other day
Drug: Interferon beta-1b group
Patients receive interferon beta-1b 250ug subcutaneously every other day
Experimental: 2
Interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
Drug: Interferon beta-1b/Atorvastatin group
Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
Time Frame: Month 0
Month 0
Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Gd-enhancing lesions on T1-weighted images after 12 months of treatment.
Time Frame: Month 0
Month 0
Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.
Time Frame: Month 0
Month 0
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
Month 0
Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] )
Time Frame: Month 0
Month 0
Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )
Time Frame: Month 0
Month 0
Number of relapse-free patients after 12 months of treatment
Time Frame: Month 0
Month 0
Relapse rate after 12 months of treatment
Time Frame: Month 0
Month 0
Time to first relapse
Time Frame: Month 0
Month 0
Gd-enhancing lesions on T1-weighted images after 12 months of treatment.
Time Frame: Month 12
Month 12
Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.
Time Frame: Month 12
Month 12
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
Month 12
Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] )
Time Frame: Month 12
Month 12
Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )
Time Frame: Month 12
Month 12
Number of relapse-free patients after 12 months of treatment
Time Frame: Month 12
Month 12
Relapse rate after 12 months of treatment
Time Frame: Month 12
Month 12
Time of first relapse
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

PharmaPart
Viollier AG, Basel, Switzerland

Investigators

  • Principal Investigator: Heinrich Mattle, Prof., Dep. of Neurology, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

April 25, 2010

First Posted (Estimate)

April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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