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NCT04447937 Clinical Trial

Immunodeficiency in MS

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04447937
Other study ID # NPI-110
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 29, 2020
Est. completion date July 30, 2021

Study information
Verified date June 2020
Source Advanced Neurosciences Institute
Contact Samuel F Hunter, MD, PhD
Phone 6157915470
Email sfhunter@neurosci.us
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1500
Est. completion date July 30, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• No Interventions
There are no interventions associated with the study.

Locations
Country Name City State
United States Advanced Neurosciences Institute Franklin Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Advanced Neurosciences Institute Novel Pharmaceutics Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunoglobulin Levels IgG, IgA, IgM 1 year
Secondary Infections Serious and non-serious 1 year
Secondary Immune-mediated conditions Serious and non-serious 1 year
Secondary Malignant and pre-malignant conditions Serious and non-serious 1 year
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