Immunodeficiency in MS

• Sponsor: Advanced Neurosciences Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04447937
• Collaborator: Novel Pharmaceutics Institute (Other)
• Enrollment: 1,500
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 115.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis; Hypogammaglobulinemia; Immunodeficiency; Infection, Bacterial	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 Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients
• Anticipated Study Start Date: Jun 29, 2020
• Anticipated Primary Completion Date: Jan 30, 2021
• Anticipated Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Immunoglobulin Levels [1 year]

   IgG, IgA, IgM

Secondary Outcome Measures

1. Infections [1 year]

   Serious and non-serious

2. Immune-mediated conditions [1 year]

   Serious and non-serious

3. Malignant and pre-malignant conditions [1 year]

   Serious and non-serious

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Neurosciences Institute	Franklin	Tennessee	United States	37064

Sponsors and Collaborators

• Advanced Neurosciences Institute
• Novel Pharmaceutics Institute

Investigators

• Principal Investigator: Samuel F Hunter, MD, PhD, Advanced Neurosciences Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Advanced Neurosciences Institute
• ClinicalTrials.gov Identifier: NCT04447937
• Other Study ID Numbers: NPI-110
• First Posted: Jun 25, 2020
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bacterial Infections; Multiple Sclerosis; Agammaglobulinemia; Immunologic Deficiency Syndromes; Sclerosis

Study Results

No Results Posted as of Jun 25, 2020