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

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Rebif (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Silva Markovic-Plese, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

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).

Clinical Details

Official title: EARLY IFNb-1a (Rebif) and Atorvastatin (Lipitor) Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome:

To determine the effects of IFNb-1a plus atorvastatin versus IFNb-1a plus placebo on the gene expression in peripheral blood mononuclear cells (PBMCs) derived from patients with isolated clinical syndrome suggestive of 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 PBMCs

Secondary outcome: evaluate safety and efficacy of combination therapy with Rebif and Lipitor in patients with clinicayy isolated syndrome suggestive of MS.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

University of North Carolina-Chapel Hill MS Clinic Within the Neuroscience Hospital, Chapel Hill, North Carolina 27599, United States
Additional Information

Starting date: October 2004
Last updated: June 22, 2009

Page last updated: August 20, 2015

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