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

Completed · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT00137176

Run by

University of North Carolina, Chapel Hill

People needed

30

Starts

2004-10-01

Expected to finish

2008-10-01

Last updated by the study team

2009-06-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina-Chapel Hill MS Clinic Within the Neuroscience Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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