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

Sponsor:	University of North Carolina, Chapel Hill
Information provided by:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00137176

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).

Condition	Intervention
Multiple Sclerosis	Drug: Rebif

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	EARLY IFNb-1a (Rebif) and Atorvastatin (Lipitor) Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Atorvastatin Atorvastatin calcium Interferon beta 1a

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

evaluate safety and efficacy of combination therapy with Rebif and Lipitor in patients with clinicayy isolated syndrome suggestive of MS. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2004
Study Completion Date:	October 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rebif + Lipitor	Drug: Rebif Rebif 44mcg TIW

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137176

Locations

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

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Silva Markovic-Plese

University of North Carolina, Chapel Hill

More Information

No publications provided

Responsible Party:	Silva Markovic-Plese, UNC Chapel Hill
ClinicalTrials.gov Identifier:	NCT00137176 History of Changes
Other Study ID Numbers:	04-NEUR-293
Study First Received:	August 26, 2005
Last Updated:	June 22, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

Clinically Isolated Syndrome

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Atorvastatin
Interferon beta 1a
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012