Immunodeficiency in MS
Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients
1 other identifier
observational
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedJune 25, 2020
June 1, 2020
7 months
June 12, 2020
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Immunoglobulin Levels
IgG, IgA, IgM
1 year
Secondary Outcomes (3)
Infections
1 year
Immune-mediated conditions
1 year
Malignant and pre-malignant conditions
1 year
Study Arms (1)
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.
Interventions
There are no interventions associated with the study.
Eligibility Criteria
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.
You may qualify if:
- One or more immunoglobulin level results and medical history available
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Neurosciences Institutelead
- Novel Pharmaceutics Institutecollaborator
Study Sites (1)
Advanced Neurosciences Institute
Franklin, Tennessee, 37064, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel F Hunter, MD, PhD
Advanced Neurosciences Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 25, 2020
Study Start
June 29, 2020
Primary Completion
January 30, 2021
Study Completion
July 30, 2021
Last Updated
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
Publications and findings from research