Biomarkers in Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT00325988|
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : February 23, 2018
This study will identify biomarkers (genes and proteins) in patients with relapsing-remitting multiple sclerosis (MS) and link them with clinical disease parameters, such as the extent of inflammation and rate of disease progression, to try to better understand the disease. It will examine how the biomarkers may be related to disease development and progression and differences among patients' symptoms and response to treatment.
Patients with relapsing-remitting MS between 18 and 60 years of age who are enrolled in the multi-institutional MS-CombiRx trial may be eligible for this sub-study. Participants have blood tests when they enter the MS-CombiRx study and again after 6 months, 1 year, and 3 years for analysis for genetic and protein analysis.
|Condition or disease|
OBJECTIVE: To identify biomarkers (by gene- and protein expression profiling, single nucleotide polymorphism (SNP) haplotype determination, HLA typing) and link these with clinical- and MRI phenotypes in a large cohort of relapsing-remitting (RR-) MS patients. To identify biomarkers that separate MS patients and healthy, matched controls.
STUDY POPULATION: Up to 1000 patients who are enrolled in and treated under a multi-center trial of combination therapy (MS-CombiRx) using two approved disease-modifying therapies (interferon-beta, IFN-b, Avonex; glatiramer-acetate, GA) as single treatments or in combination. 200 healthy, matched control individuals.
DESIGN: Samples of serum and white blood cells will be obtained on each patient prior to randomization in the MS-CombiRx study and then at 6 months 1, and 3 years following randomization. Samples will be analyzed for SNP haplotype, gene and protein expression, and HLA haplotype. Samples from controls will be analyzed in the same fashion, however, only one time point will be analyzed, and there will be no treatment of controls.
OUTCOME MEASURES: The results of the biomarker studies will be assessed in relationship to both the clinical and MRI phenotype at baseline and to change in disability, relapse rate, response to therapy and change in MRI measures of disease during the 3-year treatment period. Each of the biomarker study components will be analyzed with respect to biomarkers that discriminate between MS patients and controls.
SIGNIFICANCE: Similar to rheumatoid arthritis or autoimmune diabetes multiple sclerosis (MS) is considered a complex disease with autoimmune pathogenesis as well as vulnerability of the target tissue, i.e. the central nervous system (CNS). The results of the biomarker study should provide a better understanding of the disease pathogenesis, of the inter-individual disease heterogeneity, and finally identify biomarkers such as gene- and protein expression signatures and individual genes and proteins that are correlated with responsiveness or non-responsiveness to single drug treatment or the combination of the two drugs. The three years duration of the combination therapy trial will further allow us to gather information on the longitudinal evolution of the identified biomarkers under treatment of MS.
|Study Type :||Observational|
|Actual Enrollment :||858 participants|
|Official Title:||NINDS Biomarkers in Multiple Sclerosis Study (BioMS)|
|Study Start Date :||December 17, 2004|
|Estimated Study Completion Date :||February 3, 2014|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325988
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven Jacobson, Ph.D.||National Institute of Neurological Disorders and Stroke (NINDS)|