Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
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ClinicalTrials.gov Identifier: NCT01111656 |
Recruitment Status
:
Completed
First Posted
: April 27, 2010
Last Update Posted
: September 7, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b group Drug: Interferon beta-1b/Atorvastatin group | Phase 2 |
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 (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study") |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

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)
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Drug: Interferon beta-1b/Atorvastatin group
Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
|
- Proportion of patients with new lesions on T2-weighted images after 12 months of treatment [ Time Frame: Month 0 ]
- Proportion of patients with new lesions on T2-weighted images after 12 months of treatment [ Time Frame: Month 12 ]
- Gd-enhancing lesions on T1-weighted images after 12 months of treatment. [ Time Frame: Month 0 ]
- Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment. [ Time Frame: 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 ]
- Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 0 ]
- Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 0 ]
- Number of relapse-free patients after 12 months of treatment [ Time Frame: Month 0 ]
- Relapse rate after 12 months of treatment [ Time Frame: Month 0 ]
- Time to first relapse [ Time Frame: Month 0 ]
- Gd-enhancing lesions on T1-weighted images after 12 months of treatment. [ Time Frame: Month 12 ]
- Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment. [ Time Frame: 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 ]
- Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 12 ]
- Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 12 ]
- Number of relapse-free patients after 12 months of treatment [ Time Frame: Month 12 ]
- Relapse rate after 12 months of treatment [ Time Frame: Month 12 ]
- Time of first relapse [ Time Frame: Month 12 ]

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Ages Eligible for Study: | 18 Years to 67 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111656
Switzerland | |
Department of Neurology, Bern University Hospital, and University of Bern | |
Bern, Switzerland, 3007 |
Principal Investigator: | Heinrich Mattle, Prof. | Dep. of Neurology, Bern University Hospital |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof. H. Mattle, Department of Neurology, Inselspital, Bern University Hospital, and University of Bern, Switzerland |
ClinicalTrials.gov Identifier: | NCT01111656 History of Changes |
Other Study ID Numbers: |
75/07 |
First Posted: | April 27, 2010 Key Record Dates |
Last Update Posted: | September 7, 2011 |
Last Verified: | September 2011 |
Keywords provided by University Hospital Inselspital, Berne:
Multi-center randomized prospective |
parallel-group rater-blinded RR-MS |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons Interferon-beta Atorvastatin Calcium Interferon beta-1b |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |