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Multiple SclerosisPhase 2SWABIMSNCT00942591

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

A Phase 2 study testing Interferon beta 1b and Atorvastatin in people with Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Interferon beta 1b and Atorvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteSwitzerland
Study dates
May 2005to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Prof. H. Mattle, Dep. of Neurology, Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

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.

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"

Read more

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.

Read the 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.

Being tested
Interferon beta 1b, Atorvastatin
Keywords
multiple sclerosis, interferon beta, atorvastatin
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00942591
Study groupRoleWhat they receive
1ExperimentalInterferon beta-1b AND atorvastatin
Receives: Drug: Interferon beta 1b; Drug: Atorvastatin
2Active comparatorInterferon beta-1b
Receives: Drug: Interferon beta 1b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with new T2 lesions on MRI.

    Measured: 15 months

Secondary outcomes (4)

  1. Gd-enhancing lesion on T1-weighted images

    Measured: 15 months

  2. Clinical disease progression

    Measured: 15 months

  3. Time to first relapse

    Measured: 15 months

  4. Cortical atrophy

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2009 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00942591
Sponsor's protocol ID
17/05
Other IDs
CWCNS01
Acronym
SWABIMS
Status last verified
Jul 2009
First submitted
17 Jul 2009
Last updated
21 Jul 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Paty DW, Li DK; UBC MS/MRI Study Group and IFNB Multiple Sclerosis Study Group. Interferon beta-lb is effective in relapsing-remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. 1993 [classical article]. Neurology. 2001 Dec;57(12 Suppl 5):S10-5. No abstract available.

    PubMed 11902589

  • Youssef S, Stuve O, Patarroyo JC, Ruiz PJ, Radosevich JL, Hur EM, Bravo M, Mitchell DJ, Sobel RA, Steinman L, Zamvil SS. The HMG-CoA reductase inhibitor, atorvastatin, promotes a Th2 bias and reverses paralysis in central nervous system autoimmune disease. Nature. 2002 Nov 7;420(6911):78-84. doi: 10.1038/nature01158.

    PubMed 12422218

  • Kwak B, Mulhaupt F, Myit S, Mach F. Statins as a newly recognized type of immunomodulator. Nat Med. 2000 Dec;6(12):1399-402. doi: 10.1038/82219.

    PubMed 11100127

  • Kamm CP, Mattle HP; SWABIMS Study Group. SWiss Atorvastatin and interferon Beta-1b trial In Multiple Sclerosis (SWABIMS)--rationale, design and methodology. Trials. 2009 Dec 14;10:115. doi: 10.1186/1745-6215-10-115.

    PubMed 20003436

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interferon beta 1b and Atorvastatin in people with Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with new T2 lesions on MRI. (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00942591, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2009.

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