Alterations in CD8αβ and CD8αα T Cell Levels in Patients With Rheumatoid Arthritis
1 other identifier
observational
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2023
Typical duration for all trials
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
First Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 25, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 25, 2023
April 1, 2023
2 years
March 30, 2023
April 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
detection the level of circulating CD4+ and CD4- T cells expressing CD8αα and CD8αβ in peripheral blood and synovial fluid aspirates of RA patients.
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 Outcomes (1)
numbers of patients have remission
baseline
Study Arms (2)
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.
controls group
healthy subjects
Interventions
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+
Eligibility Criteria
30 patient with RA In addition 30 age and sex-matched healthy blood donors will be included as a control group.
You may qualify if:
- 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 .
You may not qualify if:
- Patients with autoimmune diseases other than RA. Patients or controls with tumors, infections, or other severe organ damage.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (11)
Smolen JS, Steiner G. Therapeutic strategies for rheumatoid arthritis. Nat Rev Drug Discov. 2003 Jun;2(6):473-88. doi: 10.1038/nrd1109.
PMID: 12776222BACKGROUNDZhang F, Wei K, Slowikowski K, Fonseka CY, Rao DA, Kelly S, Goodman SM, Tabechian D, Hughes LB, Salomon-Escoto K, Watts GFM, Jonsson AH, Rangel-Moreno J, Meednu N, Rozo C, Apruzzese W, Eisenhaure TM, Lieb DJ, Boyle DL, Mandelin AM 2nd; Accelerating Medicines Partnership Rheumatoid Arthritis and Systemic Lupus Erythematosus (AMP RA/SLE) Consortium; Boyce BF, DiCarlo E, Gravallese EM, Gregersen PK, Moreland L, Firestein GS, Hacohen N, Nusbaum C, Lederer JA, Perlman H, Pitzalis C, Filer A, Holers VM, Bykerk VP, Donlin LT, Anolik JH, Brenner MB, Raychaudhuri S. Defining inflammatory cell states in rheumatoid arthritis joint synovial tissues by integrating single-cell transcriptomics and mass cytometry. Nat Immunol. 2019 Jul;20(7):928-942. doi: 10.1038/s41590-019-0378-1. Epub 2019 May 6.
PMID: 31061532BACKGROUNDWu J, Zhou C, Robertson J, Weng CC, Meistrich ML, Tailor RC, Lou YH. Identification of a bone marrow-derived CD8alphaalpha+ dendritic cell-like population in inflamed autoimmune target tissue with capability of inducing T cell apoptosis. J Leukoc Biol. 2010 Nov;88(5):849-61. doi: 10.1189/jlb.0310133. Epub 2010 Jul 13.
PMID: 20628068BACKGROUNDQiu Y, Peng K, Liu M, Xiao W, Yang H. CD8alphaalpha TCRalphabeta Intraepithelial Lymphocytes in the Mouse Gut. Dig Dis Sci. 2016 Jun;61(6):1451-60. doi: 10.1007/s10620-015-4016-y. Epub 2016 Jan 14.
PMID: 26769056BACKGROUNDSheng H, Marrero I, Maricic I, Fanchiang SS, Zhang S, Sant'Angelo DB, Kumar V. Distinct PLZF+CD8alphaalpha+ Unconventional T Cells Enriched in Liver Use a Cytotoxic Mechanism to Limit Autoimmunity. J Immunol. 2019 Oct 15;203(8):2150-2162. doi: 10.4049/jimmunol.1900832. Epub 2019 Sep 25.
PMID: 31554695BACKGROUNDZhang YY, Lin YT, Wang L, Sun XW, Dang EL, Xue K, Zhang WG, Zhang KM, Wang G, Li B. CD8alphaalpha+T cells exert a pro-inflammatory role in patients with psoriasis. Skin Health Dis. 2021 Nov 16;1(4):e64. doi: 10.1002/ski2.64. eCollection 2021 Dec.
PMID: 35663772BACKGROUNDTian J, Yan C, Jiang Y, Zhou H, Li L, Shen J, Wang J, Sun H, Yang G, Sun W. Peripheral and intestinal mucosal-associated invariant T cells in premature infants with necrotizing enterocolitis. Front Pharmacol. 2022 Sep 14;13:1008080. doi: 10.3389/fphar.2022.1008080. eCollection 2022.
PMID: 36188574BACKGROUNDWerwitzke S, Tiede A, Jacobs R, Zielinska-Skowronek M, Buyny S, Schmidt RE, Witte T. CD8alpha+beta(low) effector T cells in systemic lupus erythematosus. Scand J Immunol. 2008 May;67(5):501-8. doi: 10.1111/j.1365-3083.2008.02093.x.
PMID: 18405327BACKGROUNDParel Y, Chizzolini C. CD4+ CD8+ double positive (DP) T cells in health and disease. Autoimmun Rev. 2004 Mar;3(3):215-20. doi: 10.1016/j.autrev.2003.09.001.
PMID: 15110234BACKGROUNDSarrabayrouse G, Bossard C, Chauvin JM, Jarry A, Meurette G, Quevrain E, Bridonneau C, Preisser L, Asehnoune K, Labarriere N, Altare F, Sokol H, Jotereau F. CD4CD8alphaalpha lymphocytes, a novel human regulatory T cell subset induced by colonic bacteria and deficient in patients with inflammatory bowel disease. PLoS Biol. 2014 Apr 8;12(4):e1001833. doi: 10.1371/journal.pbio.1001833. eCollection 2014 Apr.
PMID: 24714093BACKGROUNDBang K, Lund M, Wu K, Mogensen SC, Thestrup-Pedersen K. CD4+ CD8+ (thymocyte-like) T lymphocytes present in blood and skin from patients with atopic dermatitis suggest immune dysregulation. Br J Dermatol. 2001 Jun;144(6):1140-7. doi: 10.1046/j.1365-2133.2001.04223.x.
PMID: 11422033BACKGROUND
Biospecimen
1. Two milliliters of whole blood samples from all patients and controls will be collected into EDTA-containing vacutainer tubes. 2. Synovial fluid samples will be obtained by needle aspiration guided by musculoskeletal ultrasonography from inflamed knee joints in complete aseptic field and sterile technique to prevent microbial contamination of both the joint space and the aspirated synovial fluid.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 25, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2025
Study Completion
December 1, 2025
Last Updated
April 25, 2023
Record last verified: 2023-04