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Genes and Environment in Multiple Sclerosis (GEMS)

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Columbia University

Status

Enrolling

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT01353547
AAAR4456

Details and patient eligibility

About

The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is not a disease caused by a single variation in genetic material (DNA), a single environmental factor, or a single malfunction in immune cells, there are genetic alterations, environmental exposures and immunologic factors that make the development of MS more likely. Obtaining information about who is at risk for MS will be beneficial in the future if the investigators can identify effective ways to prevent or slow down the progression of this disease.

Full description

MS is an autoimmune disease in which the immune system (white bloods cells that normally fight infection) becomes misdirected and attacks healthy tissue. In patients with MS, the misdirected white blood cells attack myelin, a lining that insulates the nerves found in the brain and spinal cord. This results in inflammation and damage in the myelin. Loss of this protective lining disrupts nerve impulses and causes abnormal function in the nervous system.

This large research study will ultimately enroll 5000 subjects who are at risk of developing MS.

Enrollment

5,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • First Degree Relatives of Patients with MS, or
  • Patients who have received anti-TNFa therapy as treatment for inflammatory diseases other than MS such as Crohn's disease, psoriasis and rheumatoid arthritis, or
  • Patients that have been referred for an evaluation of first presentation of neurologic symptoms but do not have a diagnosis of MS
  • Live in the United States

Exclusion criteria

  • Does not match any of the inclusion criteria

Trial design

5,000 participants in 3 patient groups

Received anti-TNFa therapy
Description:
Received anti-TNFa therapy
First-degree relative of MS patients
Description:
First-degree relative (child, parent or sibling) of a diagnosed MS patient A subgroup will be asked to undergo magnetic resonance imaging (MRI). Participants may be asked to donate a stool sample for gut flora analysis and a blood sample for ribonucleic acid (RNA) sequencing.
Referred by the Partners MS Center
Description:
Referred by the Partners MS Center

Trial contacts and locations

5

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Central trial contact

Rifat Iqbal; Juliana Oyegunle

Data sourced from clinicaltrials.gov

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