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

NCT ID: NCT00137176

Last Updated: 2009-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-10-31

Brief 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).

Detailed Description

Multiple Sclerosis (MS) is a chronic neurologic disease, characterized pathologically by focal areas of inflammation, demyelination, axonal injury and degeneration in the central nervous system. MS follows several different disease courses. Approximately, 90% of patients have a relapsing form of the disease. We propose that atorvastatin (Lipitor) may enhance the immunomodulatory effects of INFb-1a (Rebif) in patients with clinically isolated neurological syndrome suggestive of MS. This combination may be more effective in preventing development of definitive relapsing-remitting MS if administered early in the course of the disease. The study will identify markers of disease activity that are selectively affected by this combination therapy. Identified markers may be used in future clinical trials to predict patient's clinical response and to monitor the response to treatment as a secondary outcome measure.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Rebif + Lipitor

Group Type: EXPERIMENTAL

Rebif

Intervention Type: DRUG

Rebif 44mcg TIW

Interventions

Rebif

Rebif 44mcg TIW

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

UNC Chapel Hill

Principal Investigators

Silva Markovic-Plese

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina-Chapel Hill MS Clinic Within the Neuroscience Hospital

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

04-NEUR-293

Identifier Type: -

Identifier Source: org_study_id