Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01111656
• Date of registration: 15/03/2010
• Prospective Registration: No
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
• Scientific title: SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study ("SWABIMS Follow Up-study")
• Date of first enrolment: March 2007
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01111656
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Heinrich Mattle, Prof.
• Affiliation: Dep. of Neurology, Bern University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Successful completion of the SWABIMS study

- Written informed consent

Exclusion Criteria

- Any disease other than multiple sclerosis that would better explain the patient's
signs and symptoms

- Secondary progressive MS

- Uncontrolled severe medical disorder

- Participation in any other studies



Age minimum: 18 Years
Age maximum: 67 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: Interferon beta-1b/Atorvastatin group

Drug: Interferon beta-1b group

Primary Outcome(s)

Proportion of patients with new lesions on T2-weighted images after 12 months of treatment [Time Frame: Month 12]

Proportion of patients with new lesions on T2-weighted images after 12 months of treatment [Time Frame: Month 0]

Secondary Outcome(s)

Clinical disease progression (Expanded Disability Status Scale [EDSS], Multiple Sclerosis Functional Composite [MSFC] ) [Time Frame: Month 0]

Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI) after 12 months of treatment [Time Frame: Month 0]

Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] ) [Time Frame: Month 12]

Number of relapse-free patients after 12 months of treatment [Time Frame: Month 12]

Clinical disease progression (Expanded Disability Status Scale [EDSS] , Multiple Sclerosis Functional Composite [MSFC] ) [Time Frame: Month 12]

Relapse rate after 12 months of treatment [Time Frame: Month 12]

Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment. [Time Frame: Month 12]

Gd-enhancing lesions on T1-weighted images after 12 months of treatment. [Time Frame: Month 12]

Time of first relapse [Time Frame: Month 12]

Total T2-hyperintense lesion volume (burden of disease, BOD) after 12 months of treatment. [Time Frame: Month 0]

Functional systems scores (of Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite [MSFC] ) [Time Frame: Month 0]

Number of relapse-free patients after 12 months of treatment [Time Frame: Month 0]

Gd-enhancing lesions on T1-weighted images after 12 months of treatment. [Time Frame: Month 0]

Cortical atrophy (changes in brain volume, changes in grey matter and white matter) on magnetic resonance imaging (MRI)after 12 months of treatment [Time Frame: Month 12]

Relapse rate after 12 months of treatment [Time Frame: Month 0]

Time to first relapse [Time Frame: Month 0]

Secondary ID(s)

75/07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PharmaPart GmbH, Thalwil, Switzerland

Viollier AG, Basel, Switzerland