Genes and Environment in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Integrating Genetic and Environmental Risk Scores Into an Algorithm to Predict Multiple Sclerosis Susceptibility
Overview
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.
Detailed 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.
Primary outcome measures
- Total number of subjects who are diagnosed with MS [Time frame: 20 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- National Institute of Neurological Disorders and Stroke — Bethesda
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
- Columbia University Irving Center — New York
- University of Pittsburgh — Pittsburgh
Publications
- Laitinen AW, Tozlu C, Roostaei T, Diallo F, Onomichi K, Son J, Xia Z, De Jager PL. A Prospective Study of Individuals at Risk of Multiple Sclerosis Informs the Design of Primary Prevention Studies. Ann Clin Transl Neurol. 2026 Feb 17. doi: 10.1002/acn3.70340. Online ahead of print. PMID 41700751
- Xia Z, Steele SU, Bakshi A, Clarkson SR, White CC, Schindler MK, Nair G, Dewey BE, Price LR, Ohayon J, Chibnik LB, Cortese IC, De Jager PL, Reich DS. Assessment of Early Evidence of Multiple Sclerosis in a Prospective Study of Asymptomatic High-Risk Family Members. JAMA Neurol. 2017 Mar 1;74(3):293-300. doi: 10.1001/jamaneurol.2016.5056. PMID 28114441
Identifiers
NCT: NCT01353547 · AAAR4456