Multiple SclerosisNCT04447937
Immunodeficiency in MS
An observational study of Multiple Sclerosis and Hypogammaglobulinemia, run by Advanced Neurosciences Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Hypogammaglobulinemia, Immunodeficiency
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Neurosciences Institute
Franklin, Tennessee, 37064
Samuel F Hunter, MD, PhD, 615-791-5470, sfhunter@neurosci.us
Amy L Dix, MPAS, PA-C, (913)-660-4751, aldix@neurosci.us
About this study
Official title: 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.
Read the 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.
- Being tested
- No Interventions
- Medical subject headings
- Multiple Sclerosis, Agammaglobulinemia, Immunologic Deficiency Syndromes, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
There are no interventions associated with the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoglobulin Levels
IgG, IgA, IgM
Measured: 1 year
Secondary outcomes (3)
Infections
Serious and non-serious
Measured: 1 year
Immune-mediated conditions
Serious and non-serious
Measured: 1 year
Malignant and pre-malignant conditions
Serious and non-serious
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start29 Jun 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Neurosciences Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novel Pharmaceutics Institute
- Responsible party
- Sponsor
- Investigators
- Samuel F Hunter, MD, PhD, Principal investigator, Advanced Neurosciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447937
- Sponsor's protocol ID
- NPI-110
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publications and findings from research
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04447937
- Acronym / sponsor ID
- NPI-110
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Advanced Neurosciences InstituteUniversity, hospital or other
- Collaborators
- Novel Pharmaceutics Institute
- Study start
- 29 Jun 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis and Related Diseases | – | Other: No InterventionsIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsThere are no interventions associated with the study. | Other | Multiple Sclerosis and Related Diseases |
Primary outcome
Immunoglobulin Levels
Time frame: 1 year
IgG, IgA, IgM
3 secondary outcomes
Infections
Time frame: 1 year
Immune-mediated conditions
Time frame: 1 year
Malignant and pre-malignant conditions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No. Publications and findings from research
Related trials for Multiple Sclerosis
RecruitingObservational study
Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
Recruiting
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Multiple Sclerosis, Clinically Isolated Syndrome
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel F Hunter, MD, PhD principal investigator
Advanced Neurosciences Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Hypogammaglobulinemia, run by Advanced Neurosciences Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel F Hunter, MD, PhD (6157915470, sfhunter@neurosci.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunoglobulin Levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020; AzTrials last refreshed its copy on 27 Oct 2026.