Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b (SWABIMS)
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.
|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.|
- Proportion of patients with new T2 lesions on MRI. [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||May 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Interferon beta-1b AND atorvastatin
|Drug: Interferon beta 1b Drug: Atorvastatin|
Active Comparator: 2
|Drug: Interferon beta 1b|
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.
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.
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.
|Prof. H. Mattle, Dep. of Neurology, Bern University Hospital|
|Bern, Switzerland, 3010|
|Principal Investigator:||Mattle||Dep. of Neurology, Bern University hospital|