Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

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).


Study summary:

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.


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


Study is Available At:


Original ID:

04-NEUR-293


NCT ID:

NCT00137176


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Silva Markovic-Plese
Principal Investigator
University of North Carolina, Chapel Hill

Study Dates

Start Date:October 2004
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2007
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:June 22, 2009
First Received Date:August 26, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:evaluate safety and efficacy of combination therapy with Rebif and Lipitor in patients with clinicayy isolated syndrome suggestive of MS.
Time Frame:2 years
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Time Frame:2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Time Frame:2 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Rebif
Description:Rebif 44mcg TIW
Arm Name:Rebif + Lipitor

Study Arms

Study Arm Type:Experimental
Arm Name:Rebif + Lipitor

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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