Deficient T Regulatory Cell (Treg) Function in Patients With Relapsing Remitting Multiple Sclerosis
1 other identifier
observational
80
1 country
1
Brief Summary
The purpose of this research is to find out how the T regulatory (Treg) cells control autoimmune response in multiple sclerosis. The investigators will identify Treg molecular markers and changes in function in patients with relapse remitting multiple sclerosis (RRMS). The investigators plan to study T regulatory immune cells in the blood of RRMS patients and control subjects to examine how Treg immune cells' deficient function may be involved in the development of mulitple sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Typical duration for all trials
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
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 15, 2022
June 1, 2022
3 years
April 20, 2021
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Characterize natural (n) Tregs' functional deficit in RRMS
Functional suppression assays will compare Treg suppressive function in a third cohort of 10 HC and 10 RRMS patients.
Baseline
Identify the role of inducible (i) Treg cells in maintaining the immunological tolerance in RRMS
Baseline
Secondary Outcomes (6)
Identify the phenotype changes in CD4+CD25+CD127 nTregs in RRMS patients
Baseline
Characterize functional deficits of nTregs in RRMS
Baseline
Determine the effects of hemostatic cytokines on the nTregs' suppressive function in RRMS
Baseline
Determine the phenotype of iTreg cells in RRMS
Baseline
Identify the mechanisms of deficient nTreg induction of iTregs in RRMS
Baseline
- +1 more secondary outcomes
Study Arms (2)
Patients with Relapse Remitting Multiple Sclerosis
Blood sample
Healthy Controls
Blood Sample
Eligibility Criteria
40 Patients with relapse remitting multiple sclerosis (RRMS), 40 Healthy Controls
You may qualify if:
- Confirmed diagnosis of RRMS according to McDonald's diagnostic criteria
- Age 18-55
- Extended disability status score (EDSS) 1.5-5.5
- No immunomodulatory therapy at the time of the study. (Treatment-free period will be at least 4 weeks for IV Methylprednisolone, Interferon-beta, Glatiramer acetate, Fingolimod, Tecfidera and Natalizumab. Patients previously treated with immunosuppressive therapies, including Azathioprine, Methotrexate, Mitoxantrone and Cyclophosphamide will not be enrolled in the study.)
You may not qualify if:
- Concomitant infection
- Significant medical and psychiatric condition at the discretion of principal investigator
- Pregnant women
- Patients participating in other research trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Biospecimen
Blood sample
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 23, 2021
Study Start
June 1, 2020
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
June 15, 2022
Record last verified: 2022-06