Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis

NCT03374527 | Completed

• 1 other identifier: T-ART
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the link between pro-inflammatory T cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis. The study is based on the hypothesis that a fraction of T cells with memory phenotype can recirculate from the skin and relocalize at extracutaneous sites including enthesis or synovial tissue thus propagating the pro-inflammatory cycle. This could represent a pathogenic mechanism in the development of PsA. The main aim of the study is to define the phenotypic and functional differences of circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in control group of healthy subject. To this end the investigators analyze the expression of cell surface markers of central memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets the investigators evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. There will be also an evaluation of the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the cytokine expression profile. In selected patients with PsA the researchers analyze in parallel the phenotype and the cytokine profile of T cell subpopulations in peripheral blood and in synovial fluid, The results of this study could possibly allow to define distinctive features of circulating T cells in patients with PsA and to understand the link between circulating and synovial fluid T cells in patients with PsA.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

T-cells; circulation; synovial fluid; psoriasis; psoriatic arthritis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the percentage of different subsets of memory T cells in the circulation of patients with psoriasis, patients with psoriatic arthritis and a control group of healthy subject.

  Central memory, Effector memory and Effector cell markers are evaluated in circulating CD4 and CD8 T cells. Within these subsets the expression of chemokine receptors is also evaluated and we define the cytokine secretion profile for each subset.

  At time of blood collection

Secondary Outcomes (2)

• Correlation between the circulating percentage of individual subsets of CD4 and CD8 T cells and the clinical disease parameters: Psoriasis Area and Severity Index (PASI) Score and serum level of C reactive protein (CRP)

  At time of blood collection

• Parallel analysis of the phenotype of CD4 and CD8 T cells in the circulation and in synovial fluid of patients with psoriatic arthritis.

  At time of blood and synovial fluid collection

Study Arms (3)

Psoriasis

Patients with psoriasis vulgarism without clinical signs of PsA

Other: blood sample collection

Psoriatic Arthritis (PsA)

Patients with a diagnosis of psoriatic arthritis and cutaneous psoriasis

Other: blood sample collection; Procedure: Synovial Fluid collection

Control group

Healthy subjects

Other: blood sample collection

Interventions

blood sample collection OTHER

Blood samples are collected from patients with psoriasis vulgaris and patients with psoriatic arthritis following the routine procedure. Blood samples will also be collected from healthy control subjects.

Control group; Psoriasis; Psoriatic Arthritis (PsA)

Synovial Fluid collection PROCEDURE

Synovial fluid is collected when prescribed in patients with psoriatic arthritis

Psoriatic Arthritis (PsA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort

You may qualify if:

• Patients with a diagnosis of cutaneous psoriasis without clinical signs of PsA,
• Patients with a diagnosis of PsA
• Healthy subjects with a negative family and personal anamnesis for psoriasis.
• Absence of acute and chronic systemic or cutaneous infections during sample collections.

You may not qualify if:

• Treatment with cyclosporin A, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

Location

Related Publications (3)

• Diani M, Galasso M, Cozzi C, Sgambelluri F, Altomare A, Cigni C, Frigerio E, Drago L, Volinia S, Granucci F, Altomare G, Reali E. Blood to skin recirculation of CD4+ memory T cells associates with cutaneous and systemic manifestations of psoriatic disease. Clin Immunol. 2017 Jul;180:84-94. doi: 10.1016/j.clim.2017.04.001. Epub 2017 Apr 6.

  PMID: 28392462 RESULT

• Sgambelluri F, Diani M, Altomare A, Frigerio E, Drago L, Granucci F, Banfi G, Altomare G, Reali E. A role for CCR5(+)CD4 T cells in cutaneous psoriasis and for CD103(+) CCR4(+) CD8 Teff cells in the associated systemic inflammation. J Autoimmun. 2016 Jun;70:80-90. doi: 10.1016/j.jaut.2016.03.019. Epub 2016 Apr 8.

  PMID: 27068801 RESULT

• Casciano F, Diani M, Altomare A, Granucci F, Secchiero P, Banfi G, Reali E. CCR4+ Skin-Tropic Phenotype as a Feature of Central Memory CD8+ T Cells in Healthy Subjects and Psoriasis Patients. Front Immunol. 2020 Apr 3;11:529. doi: 10.3389/fimmu.2020.00529. eCollection 2020.

  PMID: 32318062 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells, blood serum, synovial fluid mononuclear cells, synovial fluid

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Eva Reali, Dr.

  I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 15, 2017
• Study Start: October 16, 2014
• Primary Completion: January 30, 2018
• Study Completion: June 13, 2018
• Last Updated: September 9, 2019

Record last verified: 2019-08

Locations

IT (1)