EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif) and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome suggestive of multiple sclerosis (MS), to identify markers of therapeutic response, and to predict patients' clinical response based on their in vitro response to this combination therapy measured by the gene expression levels in activated peripheral blood mononuclear cells (PBMCs).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Atorvastatin Calcium; Interferon beta-1a

Criteria

Inclusion Criteria:

• Patients with isolated clinical syndrome suggestive of MS

• At least three out of four magnetic resonance imaging (MRI) findings on the initial scan:

• One Gd-enhancing lesion or nine T2 hyperintense lesions;

• At least one infratentorial lesion;

• At least one juxtacortical lesion; and

• At least three periventricular lesions.

• Expanded Disability Status Scale (EDSS) 0-5.5

• 18 to 60 years of age

• At least one relapse in previous 12 months

Exclusion Criteria:

• Patients with a diagnosis of clinically definitive relapsing-remitting (RR) MS, secondary progressive, or primary progressive MS.

• Patients who have ever been treated with mitoxantrone, cytoxan, cyclophosphamide, or total lymphoid irradiation (TLI).

• Patients treated with IFNb-1a, IFNb-1b, glatiramer acetate, intravenous immunoglobulins (IVIg), plasma exchange, methotrexate, or azathioprine in the previous 3 months.

• Patients treated with intravenous or oral steroids within 30 days prior to baseline MRI.

• Patients who have been treated with statins in the previous 3 months.

• Pregnant or breast-feeding women.

• Patients with a history of severe cardiac, hepatic, pulmonary, gastrointestinal, or renal disease.

• Abnormal baseline blood tests including alanine transaminase (ALT) or aspartate transaminase (AST) greater than twice the upper limit of normal