SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study")
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Arms & Interventions
1
Interferon beta-1b 250ug subcutaneously every other day
Intervention: Interferon beta-1b group (Drug)
2
Interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
Intervention: Interferon beta-1b/Atorvastatin group (Drug)
Outcomes
Primary Outcomes
Proportion of patients with new lesions on T2-weighted images after 12 months of treatment
Time Frame: Month 12
Secondary Outcomes
- Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment.(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(Month 0)
- Gd-enhancing lesions on T1-weighted images after 12 months of treatment.(Month 12)
- Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] )(Month 0)
- Time to first relapse(Month 0)
- Time of first relapse(Month 12)
- Number of relapse-free patients after 12 months of treatment(Month 12)
- Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] )(Month 12)
- Relapse rate after 12 months of treatment(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(Month 12)
- Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] )(Month 12)