Immunodeficiency in MS

NCT ID: NCT04447937

Last Updated: 2020-06-25

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

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-07-30

Brief Summary

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The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS.

Detailed Description

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The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS. By understanding this relationship future studies can be designed to create a model of immunosenescence in multiple sclerosis, which could help healthcare providers to predict and assess health risks. Preventative strategies can then be tested to look for ways to prevent these immune-related risks.

Conditions

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Multiple Sclerosis Hypogammaglobulinemia Immunodeficiency Infection, Bacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Multiple Sclerosis and Related Diseases

Individuals with one or more immunoglobulin level results and medical histories available for data collection will be included. Subjects will be 18 years of age or older at the time of data collection.

No Interventions

Intervention Type OTHER

There are no interventions associated with the study.

Interventions

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No Interventions

There are no interventions associated with the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* One or more immunoglobulin level results and medical history available
* 18 years of age or older at the time of data collection
* Patients with first symptom MS or other isolated demyelinating syndromes, neuromyelitis optica, or rheumatic-associated CNS inflammation

Exclusion Criteria

* No evidence of CNS autoimmune disease
* Less than 18 years of age at the time of data abstraction
* Undergoing plasma exchange at the time of any lab tests drawn
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novel Pharmaceutics Institute

UNKNOWN

Sponsor Role collaborator

Advanced Neurosciences Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel F Hunter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Advanced Neurosciences Institute

Locations

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Advanced Neurosciences Institute

Franklin, Tennessee, United States

Site Status

Countries

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United States

Central Contacts

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Samuel F Hunter, MD, PhD

Role: CONTACT

6157915470

Julia G Dickenson, BS, BA

Role: CONTACT

6157915470

Facility Contacts

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Samuel F Hunter, MD, PhD

Role: primary

615-791-5470

Amy L Dix, MPAS, PA-C

Role: backup

(913)-660-4751

Other Identifiers

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NPI-110

Identifier Type: -

Identifier Source: org_study_id

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