Genes and Environment in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— GEMS  

Official title:

Integrating Genetic and Environmental Risk Scores Into an Algorithm to Predict Multiple Sclerosis Susceptibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01353547
• Other study ID #: AAAR4456
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: October 2040

Study information

• Verified date: September 2022
• Source: Columbia University
• Contact: Fatoumata B. Diallo, BS
• Phone: 212-304-1548
• Email: fd2292[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: October 2040
• Est. primary completion date: October 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke	Bethesda	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Columbia University Irving Center	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Brigham and Women's Hospital, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of subjects who are diagnosed with MS	For each subject, weighted integrated risk score will be calculated, combining genetic burden and environmental exposure. A distribution of the risk score will be generated for the cohort. At this stage, the study will assess whether there is an increase in subjects with a diagnosis of MS (validated by a letter or copy of clinical records from the subject's neurologist) within the higher end vs. the lower end of the risk score distribution.	20 years