Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b (SWABIMS)

This study has been completed.
Sponsor:
Collaborators:
CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil
Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00942591
First received: July 17, 2009
Last updated: July 20, 2009
Last verified: July 2009
  Purpose

Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis

Short title: "SWABIMS"

Study phase: Phase IIb study

Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland

Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta

Reference product: Interferon-beta-1b 250mg given

Indication: Relapsing-remitting multiple sclerosis (RR-MS)

Study objectives: Comparison of efficacy, safety and tolerability of combination of Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d.

Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.


Condition Intervention Phase
Multiple Sclerosis
Drug: Interferon beta 1b
Drug: Atorvastatin
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: Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of patients with new T2 lesions on MRI. [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Gd-enhancing lesion on T1-weighted images [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Clinical disease progression [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Time to first relapse [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Cortical atrophy [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: May 2005
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interferon beta-1b AND atorvastatin
Drug: Interferon beta 1b Drug: Atorvastatin
Active Comparator: 2
Interferon beta-1b
Drug: Interferon beta 1b

Detailed Description:

Background

Multiple sclerosis is considered to be a chronic inflammatory demyelinating 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 seem to 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

The objectives of this study are 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.

Methods

Multi-center, rater-blinded, parallel-group, two arm, randomized study. Patients with relapsing-remitting forms of MS, respecting all inclusion/exclusion criteria, will be randomized into two equal-size parallel arms after three months of treatment with Interferon-beta-1b, receiving Atorvastatin 40mg/d or not. Enrolment of 80 patients (1/2 in the Atorvastatin group) is planned. Patients providing written informed consent will be treated for 15 months.

Inclusion criteria: Patients with relapsing-remitting forms of multiple sclerosis with disease duration > 3 month and < 5 years, at least 1 relapse in the past two years, > 3 Lesions on spinal or brain-MRI, EDSS score between 0 and 3.5, inclusive, age between 18 and 55 years.

Exclusion criteria: Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms, Primary progressive MS, Secondary progressive MS, and others.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria)
  • At least 1 relapse in the past two year
  • > 3 Lesions on spinal or brain-MRI
  • EDSS score between 0 and 3.5, inclusive
  • Age between 18 and 55 years
  • Written informed consent
  • Negative pregnancy test results (all women)

Exclusion Criteria

  • Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
  • Primary progressive MS
  • Secondary progressive MS
  • Uncontrolled severe medical disorder
  • A history of drug abuse in the 6 months prior to screening
  • Previous therapy with Monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (except steroids)
  • 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: NCT00942591

Locations
Switzerland
Prof. H. Mattle, Dep. of Neurology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil
Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel
Investigators
Principal Investigator: Mattle 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. Heinrich Paul Mattle, Chefarzt, Department of Neurology, University Hospital Bern, Freiburgstr. 3010 Bern
ClinicalTrials.gov Identifier: NCT00942591     History of Changes
Other Study ID Numbers: 17/05, CWCNS01
Study First Received: July 17, 2009
Last Updated: July 20, 2009
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
multiple sclerosis
interferon beta
atorvastatin

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
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on October 01, 2014