Immunodeficiency in MS

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Infection, Bacterial; Immunodeficiency; Hypogammaglobulinemia
• Intervention / Treatment: Other: No Interventions

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Samuel F Hunter, MD, PhD; Phone Number: 6157915470; Email: sfhunter@neurosci.us
• Study Contact Backup: Name: Julia G Dickenson, BS, BA; Phone Number: 6157915470; Email: jgdickenson@neurosci.us

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37064
      • Advanced Neurosciences Institute
      • Contact: Samuel F Hunter, MD, PhD; Phone Number: 615-791-5470; Email: sfhunter@neurosci.us
      • Contact: Amy L Dix, MPAS, PA-C; Phone Number: (913)-660-4751; Email: aldix@neurosci.us
      • Sub-Investigator: Julia G Dickenson, BS, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective data from 1500 patients with immune-mediated CNS disease is expected to be used from the electronic medical record eClinicalWorks and other electronic and paper archives of Advanced Neurosciences Institute.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Interventions; There are no interventions associated with the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunoglobulin Levels	IgG, IgA, IgM	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infections	Serious and non-serious	1 year
Immune-mediated conditions	Serious and non-serious	1 year
Malignant and pre-malignant conditions	Serious and non-serious	1 year

Collaborators and Investigators

• Sponsor: Advanced Neurosciences Institute
• Collaborators: Novel Pharmaceutics Institute
• Investigators: Principal Investigator: Samuel F Hunter, MD, PhD, Advanced Neurosciences Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): June 29, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Hematologic Diseases; Blood Protein Disorders; Bacterial Infections and Mycoses; Multiple Sclerosis; Sclerosis; Immunologic Deficiency Syndromes; Bacterial Infections; Agammaglobulinemia
• Other Study ID Numbers: NPI-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publications and findings from research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No