NCT00325988

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
858

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2014

Completed
Last Updated

December 17, 2019

Status Verified

February 3, 2014

First QC Date

May 15, 2006

Last Update Submit

December 14, 2019

Conditions

Multiple Sclerosis

Keywords

NeuroimmunologyDemyelinating DiseaseGeneticsProteins

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wynn DR, Rodriguez M, O'Fallon WM, Kurland LT. A reappraisal of the epidemiology of multiple sclerosis in Olmsted County, Minnesota. Neurology. 1990 May;40(5):780-6. doi: 10.1212/wnl.40.5.780.

    PMID: 2082944BACKGROUND

  • Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52. doi: 10.1056/NEJM200009283431307. No abstract available.

    PMID: 11006371BACKGROUND

  • Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996 Apr;46(4):907-11. doi: 10.1212/wnl.46.4.907.

    PMID: 8780061BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisDemyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Steven Jacobson, Ph.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 15, 2006

Study Start

December 17, 2004

Study Completion

February 3, 2014

Last Updated

December 17, 2019

Record last verified: 2014-02-03

Locations

US(1)