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

This study has been completed.
Sponsor:
Collaborators:
Viollier AG, Basel, Switzerland
PharmaPart GmbH, Thalwil, Switzerland
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01111656
First received: March 15, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
Drug: Interferon beta-1b group
Drug: Interferon beta-1b/Atorvastatin group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study")

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Proportion of patients with new lesions on T2-weighted images after 12 months of treatment [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with new lesions on T2-weighted images after 12 months of treatment [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Gd-enhancing lesions on T1-weighted images after 12 months of treatment. [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment. [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Number of relapse-free patients after 12 months of treatment [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Relapse rate after 12 months of treatment [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Time to first relapse [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Gd-enhancing lesions on T1-weighted images after 12 months of treatment. [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment. [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] ) [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Number of relapse-free patients after 12 months of treatment [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Relapse rate after 12 months of treatment [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Time of first relapse [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111656

Locations
Switzerland
Department of Neurology, Bern University Hospital, and University of Bern
Bern, Switzerland, 3007
Sponsors and Collaborators
University Hospital Inselspital, Berne
Viollier AG, Basel, Switzerland
PharmaPart GmbH, Thalwil, Switzerland
Investigators
Principal Investigator: Heinrich Mattle, Prof. Dep. of Neurology, Bern University Hospital
  More Information

Publications:
Additional 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
Study First Received: March 15, 2010
Last Updated: September 6, 2011
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
Multi-center
randomized
prospective
parallel-group
rater-blinded
RR-MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Atorvastatin
Interferons
Interferon-beta
Interferon beta-1b
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 22, 2014