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

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ClinicalTrials.gov Identifier: NCT00137176
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : June 23, 2009
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill

August 26, 2005
August 29, 2005
June 23, 2009
October 2004
October 2007   (Final data collection date for 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 ]
  • 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 ]
  • To determin the effects of IFNb-1a plus atorvastatin vs. *IFNb-1a plus placebo on the gene expression in peripheral blood mononuclear cells (PBMC's) 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 PBMC's.
Complete list of historical versions of study NCT00137176 on ClinicalTrials.gov Archive Site
evaluate safety and efficacy of combination therapy with Rebif and Lipitor in patients with clinicayy isolated syndrome suggestive of MS. [ Time Frame: 2 years ]
Not Provided
Not Provided
Not Provided
 
EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis
EARLY IFNb-1a (Rebif) and Atorvastatin (Lipitor) Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis
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).
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Multiple Sclerosis
Drug: Rebif
Rebif 44mcg TIW
Experimental: Rebif + Lipitor
Intervention: Drug: Rebif
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
October 2008
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00137176
04-NEUR-293
No
Not Provided
Not Provided
Silva Markovic-Plese, UNC Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Silva Markovic-Plese University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP