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

NCT00942591 | Completed Phase 2 DMC

• 2 other identifiers: 17/05CWCNS01
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; interferon beta; atorvastatin

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with new T2 lesions on MRI.

  15 months

Secondary Outcomes (4)

• Gd-enhancing lesion on T1-weighted images

  15 months

• Clinical disease progression

  15 months

• Time to first relapse

  15 months

• Cortical atrophy

  15 months

Study Arms (2)

1

EXPERIMENTAL

Interferon beta-1b AND atorvastatin

Drug: Interferon beta 1b; Drug: Atorvastatin

2

ACTIVE COMPARATOR

Interferon beta-1b

Drug: Interferon beta 1b

Interventions

Interferon beta 1b DRUG

1; 2

Atorvastatin DRUG

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• PharmaPart: collaborator
• Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel: collaborator

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 11902589 BACKGROUND

• 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.

  PMID: 12422218 BACKGROUND

• 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.

  PMID: 11100127 BACKGROUND

• 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.

  PMID: 20003436 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b; Atorvastatin

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Mattle

  Dep. of Neurology, Bern University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 21, 2009
• Study Start: May 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 21, 2009

Record last verified: 2009-07

Locations

CH (1)