Immunodeficiency in MS

• Conditions: Immunodeficiency; Multiple Sclerosis; Hypogammaglobulinemia; Infection, Bacterial
• Interventions: Other: No Interventions

• Registration Number: NCT04447937
• Lead Sponsor: Advanced Neurosciences Institute

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25
• Study Start: 2020-06-29
• Primary Completion: 2021-01-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis and Related Diseases	No Interventions	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.

Primary Outcome Measures

Name	Time	Method
Immunoglobulin Levels	1 year	IgG, IgA, IgM

Secondary Outcome Measures

Name	Time	Method
Infections	1 year	Serious and non-serious
Immune-mediated conditions	1 year	Serious and non-serious
Malignant and pre-malignant conditions	1 year	Serious and non-serious

Trial Locations

Locations (1)

Advanced Neurosciences Institute; 🇺🇸 Franklin, Tennessee, United States