Genes and Environment in Multiple Sclerosis

NCT ID: NCT01353547

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2040-10-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Received anti-TNFa therapy

Received anti-TNFa therapy

No interventions assigned to this group

First-degree relative of MS patients

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.

No interventions assigned to this group

Referred by the Partners MS Center

Referred by the Partners MS Center

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Philip De Jager

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zongqi Xia, MD, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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National Institute of Neurological Disorders and Stroke

Bethesda, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status TERMINATED

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status TERMINATED

Columbia University Irving Center

New York, New York, United States

Site Status RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Juliana Oyegunle

Role: CONTACT

212-305-2434

Rifat Iqbal

Role: CONTACT

212-305-3261

Facility Contacts

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Juliana Oyegunle

Role: primary

2123052434

Rifat Iqbal

Role: backup

212-305-3261

References

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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.

Reference Type DERIVED
PMID: 28114441 (View on PubMed)

Other Identifiers

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AAAR4456

Identifier Type: -

Identifier Source: org_study_id

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