Status:
COMPLETED
Biomarkers in Multiple Sclerosis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - PATIENTS:
- To be eligible for entry into this study, candidates must meet the following eligibility criteria at the time of enrollment:
- Between the ages of 18 and 60 years, inclusive.
- Diagnosis of Relapsing-Remitting MS.
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5, inclusive.
- At least 2 exacerbations in the prior three years; one exacerbation may utilize the McDonald MRI criteria for dissemination in time (a new Gd-enhancing lesion demonstrated on a scan done at least 3 months following onset of a clinical attack or a new T2 lesion or Gd-enhancing lesions on a follow-up scan after an additional 3 months).
- Give written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
- EXCLUSION CRITERIA - PATIENTS:
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening (prior to randomization):
- Prior use of interferon beta or glatiramer acetate.
- Acute exacerbation within 30 days of screening.
- Steroids for acute exacerbations (greater than 100 mg/day) within 30 days of study entrance or chronic systemic steroid use.
- Evidence of progressive MS.
- Use of immunosuppressive or chemotherapeutic agents or IVIg.
- Inability to perform the MSFC (Time 25-Foot Walk, 9HPT, and PASAT3).
- Inability to undergo baseline MRI scan.
- History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta or glatiramer acetate.
- Known history of sensitivity to gadopentate dimeglumine or mannitol.
- History of a seizure within the 3 months prior to randomization.
- History of suicidal ideation or an episode of severe depression within the 3 months prior to randomization.
- Abnormal screening blood tests exceeding any of the limits defined below:
- Alanine transaminase (ALT) or aspartate transaminase (AST) greater than two times the upper limit of normal (i.e., greater than 2 times the ULN).
- Total white blood cell count less than 2,300/mm(3).
- Platelet count less than 80,000/mm(3).
- Creatinine greater than 2 times the ULN.
- Participation in another experimental clinical trial, without formal approval.
- Previous participation after randomization in this study.
- History of alcohol or drug abuse within the 2 years prior to randomization.
- Female subjects who are currently pregnant, breast-feeding, or plan to become pregnant.
- For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception.
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition that is likely to affect the subject's returning for scheduled follow-up visits on schedule (any physical, mental, or social condition, including history of any episode of suicidal ideation or severe depression defined as any episode that required hospitalization within the previous 3 months).
- INCLUSION CRITERIA - CONTROLS:
- 18 to 60 years inclusive.
- EXCLUSION CRITERIA - CONTROLS:
- Any significant acute or chronic illness, particularly no autoimmune or chronic inflammatory, -infectious disease.
- HIV positive.
- No treatment with immunomodulatory, immunosuppressive or chemotherapeutic drugs.
- Pregnancy.
- Nursing mothers.
Exclusion
Key Trial Info
Start Date :
December 17 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2014
Estimated Enrollment :
858 Patients enrolled
Trial Details
Trial ID
NCT00325988
Start Date
December 17 2004
End Date
February 3 2014
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892