CD73+ Th1.17 in Rheumatoid Arthritis and Psoriatic Arthritis

NCT03953378 | Completed

• 1 other identifier: LAdoRIC
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (3)

• CD73 expression on T helper lymphocyte subpopulations

  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.

  At inclusion

• CD73 expression on T helper lymphocyte subpopulations

  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.

  3 months

• CD73 expression on T helper lymphocyte subpopulations

  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.

  12 months

Study Arms (3)

Group "RA patients"

Patients with Rheumatoid Arthritis (RA) fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria.

Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples

Group "PsA patients"

Patients with Psoriatic Arthritis (PsA) fulfilling the Classification for PsA (CASPAR) criteria.

Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples

Group "Healthy donors"

Anonymous healthy donors from the Etablissement Français du Sang.

Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples

Interventions

Multi-parametric Flow Cytometry analysis on patients and healthy donors samples OTHER

Collection of venous blood (16 mL) and synovial fluid (when available) samples, for each patient, at inclusion and in the frame of the usual medical follow-up at 3 months and between 6 and 12 months, before the onset of MTX (untreated patients) or during the course of MTX treatment (MTX-treated patients). Collection of anonymous healthy donors blood samples, age- and sex-matched, obtained from the Etablissement Français du Sang. Multi-parametric Flow Cytometry analysis was performed on these samples to assess CD73 expression on total memory T cells and within T helper lymphocyte subsets, their cytokine production and AMPase functions. For FoxP3 intracellular staining, cells were treated using the FoxP3 Fixation and Permeabilization kit (Life Technologies), according to manufacturer instructions. Stainings were analyzed on a LSR-Fortessa™ (BD Biosciences) with conserved settings throughout the entire study and data were analyzed using FlowJo™ Software (Tree Star v10.4).

Group "Healthy donors"; Group "PsA patients"; Group "RA patients"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic inflammatory rheumatism RA and PsA types with or without background therapy at the inclsuion

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Rhumatologie, Centre Hospitalier Lyon-Sud (HCL)

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

FR (1)