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

NCT ID: NCT03374527

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-16

Study Completion Date

2018-06-13

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Psoriasis

Patients with psoriasis vulgarism without clinical signs of PsA

blood sample collection

Intervention Type 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.

Psoriatic Arthritis (PsA)

Patients with a diagnosis of psoriatic arthritis and cutaneous psoriasis

blood sample collection

Intervention Type 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.

Synovial Fluid collection

Intervention Type PROCEDURE

Synovial fluid is collected when prescribed in patients with psoriatic arthritis

Control group

Healthy subjects

blood sample collection

Intervention Type 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.

Interventions

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blood sample collection

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.

Intervention Type OTHER

Synovial Fluid collection

Synovial fluid is collected when prescribed in patients with psoriatic arthritis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Reali, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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IRCCS Galeazzi Orthopedic Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 28392462 (View on PubMed)

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.

Reference Type RESULT
PMID: 27068801 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32318062 (View on PubMed)

Other Identifiers

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T-ART

Identifier Type: -

Identifier Source: org_study_id

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