Immunodeficiency in MS

Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04447937

Enrollment

1500

Registered

2020-06-25

Start date

2020-06-29

Completion date

2021-07-30

Last updated

2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogammaglobulinemia, Immunodeficiency, Infection, Bacterial, Multiple Sclerosis

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.

Interventions

OTHERNo Interventions

There are no interventions associated with the study.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Immunoglobulin Levels	1 year	IgG, IgA, IgM

Secondary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactSamuel F Hunter, MD, PhD

sfhunter@neurosci.us6157915470

Backup ContactJulia G Dickenson, BS, BA

jgdickenson@neurosci.us6157915470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026