Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT04857489

Conditions

Relapse Remitting Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Relapse Remitting Multiple Sclerosis

Study ID

NCT04857489

Start date

Jun 1, 2020

Status verified date

Jun, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • Concomitant infection
  • Significant medical and psychiatric condition at the discretion of principal investigator
  • Pregnant women
  • Patients participating in other research trials

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Relapse Remitting Multiple Sclerosis

Blood sample

Healthy Controls

Blood Sample

Primary outcome measure

  • Characterize natural (n) Tregs' functional deficit in RRMS [ Time Frame: Baseline ]
  • Identify the role of inducible (i) Treg cells in maintaining the immunological tolerance in RRMS [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Silva Markovic-Plese, MD, PhD

215-503-6393Silva.Markovic-Plese@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Silva Markovic-Plese, MD, PhD

215-503-6393Silva.Markovic-Plese@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jun 15, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2022-06-15.