Alterations in CD8αβ and CD8αα T Cell Levels in Patients With Rheumatoid Arthritis

April 12, 2023 updated by: Hager Ahmed Ibrahim Mohammad, Assiut University
To evaluate the changes in the frequencies of circulating CD4+ and CD4- T cells expressing CD8αα and CD8αβ in peripheral blood of RA patients in comparison with healthy controls. Also, to correlate circulating and synovial fluid levels of these cells with disease activity score (DAS28) and other indices of disease severity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic, inflammatory, systemic autoimmune disease of the joints . CD4+ T cells are predominant in the synovial tissue with increased number of CD8 effector and memory T cells in synovial fluid and tissue of RA patients . CD8 functions as a dimer; including homodimer CD8αα and heterodimer CD8αβ . CD8αβ is a superior T-cell co-receptor that enhances functional avidity, CD8αα functions as a TCR corepressor to negatively regulate T cell activation . CD8αα T cells are found in human intestine and peripheral blood . CD8αα T cells increased markedly in the lesions of psoriasis where they played a pro-inflammatory role . The lower percentage of CD8αα+ mucosa associated-invariant T (MAIT) cells was found to be associated with MAIT cell dysfunction in gut immunity in necrotizing enterocolitis patients . T cells express the CD8β chain either at a high (CD8βhigh) or low density (CD8βlow ). There was a relative increase in CD8βlow cells in patients with SLE which were associated with an increased disease activity . Double positive (DP) T lymphocytes, include CD4CD8αβhigh and CD4CD8αα T cell subsets in the human blood . DP8α cells decreased in the blood and colonic mucosa of patients with inflammatory bowel disease compared with healthy individuals . CD4CD8αβhigh T cells are present at higher frequencies in some auto-immune diseases . Whether CD8αα or CD8αβ T cells contribute to the pathogenesis of RA, has not been clarified so far. investigators hypothesize that, an alteration in the frequency and distribution of these T cell subsets in RA patients might be associated with disease activity

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

30 patient with RA In addition 30 age and sex-matched healthy blood donors will be included as a control group.

Description

Inclusion Criteria:

  • Patients with RA who fulfilled the 2010 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) revised criteria for RA (12).

Patients having knee effusion .

Exclusion Criteria:

  • Patients with autoimmune diseases other than RA. Patients or controls with tumors, infections, or other severe organ damage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients group

. Inclusion criteria:

  • Patients with RA who fulfilled the 2010 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) revised criteria for RA (1
  • Patients having knee effusion .

Exclusion criteria:

  • Patients with autoimmune diseases other than RA.
  • Patients or controls with tumors, infections, or other severe organ damage.
Diagnostic test: flow cytometry

Levels of circulating and synovial fluid CD4+ and CD4- T cells expressing CD8αα and CD8αβ will be assessed by flow cytometry using fluorochrome-labelled monoclonal antibodies against CD3, CD4, CD8α and CD8β surface markers. Levels of the following cells will be assessed:

  1. CD3+CD4-CD8αα+
  2. CD3+CD4-CD8α+CD8βlow
  3. CD3+CD4-CD8α+CD8βhigh
  4. CD3+CD4+CD8αβhigh
  5. CD3+CD4+CD8αα+
controls group
healthy subjects
Diagnostic test: flow cytometry

Levels of circulating and synovial fluid CD4+ and CD4- T cells expressing CD8αα and CD8αβ will be assessed by flow cytometry using fluorochrome-labelled monoclonal antibodies against CD3, CD4, CD8α and CD8β surface markers. Levels of the following cells will be assessed:

  1. CD3+CD4-CD8αα+
  2. CD3+CD4-CD8α+CD8βlow
  3. CD3+CD4-CD8α+CD8βhigh
  4. CD3+CD4+CD8αβhigh
  5. CD3+CD4+CD8αα+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection the level of circulating CD4+ and CD4- T cells expressing CD8αα and CD8αβ in peripheral blood and synovial fluid aspirates of RA patients.
Time Frame: baseline
The frequencies of circulating CD4+ and CD4- T cells expressing CD8αα and CD8αβ in RA patients in comparison with healthy controls. and Comparing the frequencies of these cells between peripheral blood and synovial fluid aspirates of RA patients.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numbers of patients have remission
Time Frame: baseline
To assess the relation between the level of these cells and numbers of patients have remission
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2023

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T cells in RA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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