SWABIMS
What it found
The main measure did not show a significant benefit.
“At study end, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.14; 95 % CI 0.36-3.56; p = 0.81).”Read by software from the paper's abstract
proportion of patients with new lesions on T2-weighted images at month 15 compared to baseline at month three · month 15
odds ratio 1.14
p = 0.81
Read by software from the paper's abstract
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
- Atorvastatin
What it measured
Main measures
Proportion of patients with new T2 lesions on MRI.
15 months
MRI lesions
Other measures (4)
Gd-enhancing lesion on T1-weighted images
15 months
MRI lesionsClinical disease progression
15 months
Time to first relapse
15 months
RelapsesCortical atrophy
15 months
Brain volume loss
Who could take part
Relapsing MS · 18 to 55
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial.PLoS One · 2014
Results
Atorvastatin added to interferon β for relapsing multiple sclerosis: a randomized controlled trial.J Neurol · 2012
At study end, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.14; 95 % CI 0.36-3.56; p = 0.81).
Read by software from the paper's abstract
Results
SWiss Atorvastatin and interferon Beta-1b trial In Multiple Sclerosis (SWABIMS)--rationale, design and methodology.Trials · 2009
Background
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.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.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.
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Linked trials
Extended by
Efficacy, Safety and Tolerability of Atorvastatin 40 mg i…Phase 2 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
May 2005
Main results due
Apr 2009
Finished
May 2009
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