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

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ClinicalTrials.gov Identifier: NCT03374527
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

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.


Condition or disease Intervention/treatment
Psoriasis Psoriatic Arthritis Other: blood sample collection Procedure: Synovial Fluid collection

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Study Type : Observational [Patient Registry]
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis
Actual Study Start Date : October 16, 2014
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : June 13, 2018


Group/Cohort Intervention/treatment
Psoriasis
Patients with psoriasis vulgarism without clinical signs of PsA
Other: 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.

Psoriatic Arthritis (PsA)
Patients with a diagnosis of psoriatic arthritis and cutaneous psoriasis
Other: 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.

Procedure: Synovial Fluid collection
Synovial fluid is collected when prescribed in patients with psoriatic arthritis

Control group
Healthy subjects
Other: 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.




Primary Outcome Measures :
  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. [ Time Frame: At time of blood collection ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: At time of blood collection ]
    For each subsets it is calculated the correlation between the percentage in the circulation and either the Psoriasis Area and Severity Index (PASI) score or the serum level of C reactive protein

  2. Parallel analysis of the phenotype of CD4 and CD8 T cells in the circulation and in synovial fluid of patients with psoriatic arthritis. [ Time Frame: At time of blood and synovial fluid collection ]
    Phenotype and functional analysis of T Cells


Biospecimen Retention:   Samples Without DNA
Peripheral blood mononuclear cells, blood serum, synovial fluid mononuclear cells, synovial fluid


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cohort
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374527


Locations
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Italy
IRCCS Galeazzi Orthopedic Hospital
Milan, Italy, 20161
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
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Principal Investigator: Eva Reali, Dr. Istituto Ortopedico Galeazzi

Additional Information:

Publications of Results:
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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03374527     History of Changes
Other Study ID Numbers: T-ART
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Galeazzi:
T-cells
circulation
synovial fluid
psoriasis
psoriatic arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases