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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 : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Tracking Information
First Submitted Date December 11, 2017
First Posted Date December 15, 2017
Last Update Posted Date December 15, 2017
Actual Study Start Date October 16, 2014
Estimated Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 14, 2017)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis
Official Title Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis
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 we analyze the expression of cell surface markers of central memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets wel evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. We also evaluate the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the cytokine expression profile.

In selected patients with PsA we 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 us 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 Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples Without DNA
Description:
Peripheral blood mononuclear cells, blood serum, synovial fluid mononuclear cells, synovial fluid
Sampling Method Non-Probability Sample
Study Population Cohort
Condition
  • Psoriasis
  • Psoriatic Arthritis
Intervention
  • 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
Study Groups/Cohorts
  • Psoriasis
    Patients with psoriasis vulgarism without clinical signs of PsA
    Intervention: Other: blood sample collection
  • Psoriatic Arthritis (PsA)
    Patients with a diagnosis of psoriatic arthritis and cutaneous psoriasis
    Interventions:
    • Other: blood sample collection
    • Procedure: Synovial Fluid collection
  • Control group
    Healthy subjects
    Intervention: Other: blood sample collection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 14, 2017)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2018
Estimated Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of cutaneous psoriasis without clinical signs of PsA, Patients with a diagnosis of PsA Healthy subjects Criteria for patient selection included the absence of acute and chronic systemic or cutaneous infections during sample collections. Criteria for healthy controls selection included the same restrictions for patients and a negative family and personal anamnesis for psoriasis.-

Exclusion Criteria:

  • Patients or healthy subjects undergoing treatment with cyclosporin A, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections were excluded from the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Eva Reali, Dr. +39 02 66214057 eva.reali@grupposandonato.it
Contact: Elena Cittera, Dr. +39 02 66214057 elena.cittera@grupposandonato.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03374527
Other Study ID Numbers T-ART
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Istituto Ortopedico Galeazzi
Study Sponsor Istituto Ortopedico Galeazzi
Collaborators Not Provided
Investigators
Principal Investigator: Eva Reali, Dr. Istituto Ortopedico Galeazzi
PRS Account Istituto Ortopedico Galeazzi
Verification Date December 2017