CD73+ Th1.17 in Rheumatoid Arthritis and Psoriatic Arthritis

Completed

• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis
• Interventions: Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples

• Registration Number: NCT03953378
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Prospective study to investigate the correlation between CD39/CD73 expression by the different T lymphocyte subpopulations in the blood and synovial fluid (if available) into patients with chronic inflammatory rheumatism RA and PsA types, with the rheumatic activity, the background therapy (with Methotrexate (MTX)) and the response to this treatment.

Detailed Description

Th1.17 compose a recently described subset of highly polyfunctional and thus potentially more harmful CD4+ effector T cells (Teff) than classical Th17 as they co-produce interferon-γ (IFN-γ) and interleukin-17A (IL-17A). For this reason, Th1.17 rise increasing interest in RA and PsA since they seem involved in their pathophysiology. Hyper activation of Teff in RA and PsA results partly from a deficiency in regulatory mechanisms of Teff's pro-inflammatory functions. The ecto-nucleotidase CD73 delineates Teff enriched in Th1.17 features and acts as a regulatory mechanism for these pro-inflammatory cells. Considering that MTX, usually used as first line treatment of RA and PsA, increases extracellular concentrations of adenosine monophasphate (AMP) and immunosuppressive adenosine, the investigators hypothesized that CD4+CD73+ T cell effector population enriched in Th1.17 and Th17 cells may participate in the pathogenicity of RA and PsA but also in the resistance to MTX treatment through the specific expression of CD73 essential for Ado generation and which is down-regulated on proliferating T cells.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-05
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-15
• Last Update Submitted: 2019-05-15
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Patients aged ≥ 18 years
• Patients naive to biologics
• Patients with RA fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria
• Patients with PsA fulfilling the Classification for PsA (CASPAR) criteria

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group "PsA patients"	Multi-parametric Flow Cytometry analysis on patients and healthy donors samples	Patients with Psoriatic Arthritis (PsA) fulfilling the Classification for PsA (CASPAR) criteria.
Group "Healthy donors"	Multi-parametric Flow Cytometry analysis on patients and healthy donors samples	Anonymous healthy donors from the Etablissement Français du Sang.
Group "RA patients"	Multi-parametric Flow Cytometry analysis on patients and healthy donors samples	Patients with Rheumatoid Arthritis (RA) fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria.

Primary Outcome Measures

Name	Time	Method
CD73 expression on T helper lymphocyte subpopulations	12 months	Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.

Trial Locations

Locations (1)

Service de Rhumatologie, Centre Hospitalier Lyon-Sud (HCL); 🇫🇷 Pierre-Bénite, France