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Recruiting NCT05307809

Cytokine Expression in Psoriasis Patients With and Without Joint Involvement

No phase Interventional Psoriasis Psoriatic Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample collection, Skin sample collection.
Who it may be relevant to
Registry conditions: Psoriasis, Psoriatic Arthritis. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Cytokine Expression in Sera, ex Vivo Stimulated Peripheral Blood Mononuclear Cells Culture, and Skin in Psoriasis - Comparison of Patients With and Without Joint Involvement

Overview

The objective of the resarch is to study the cytokine profile of patients with psoriatic arthritis and psoriasis in order to better understand the pathophysiology of the disease and the contribution of cytokines to the presence or absence of joint involvement. This research will compare cytokines levels in sera, in PBMC culture after LPS or CD3/CD28 agonist antibodies, and in skin biopsy.

Detailed description

Psoriatic arthritis and Cutaneous Psoriasis are polygenic inflammatory disorders with high burden on the quality of life of patients. Pathophysiology of those disease remain incompletely understood. Recent publications seem to demonstrate an implication of IL-1 family cytokines in the pathogenesis of both diseases. In the literature, results are discordant and focus mainly on cytokines levels in serum of patients. Moreover, few studies compare psoriatic arthritis patients with cutaneous psoriasis patients. We propose here to study cytokines profiles of patients with those conditions in sera, after ex-vivo stimulation of peripheral blood mononuclear cells, and in skin biopsies.

Interventions

  • Other Blood sample collection
    Blood sample collection
  • Other Skin sample collection
    Skin sample collection

Primary outcome measures

  • Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups [Time frame: At inclusion]
Secondary outcome measures (2)
  • Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients [Time frame: At inclusion]
  • Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity [Time frame: At inclusion]

Eligibility criteria

Inclusion criteria

  • For psoriasis patients :
  • Age over 18 years old
  • Signed informed consent
  • 5 year old psoriasis at least
  • At least one skin lesion over 2 cm
  • Without any articular symptoms
  • Without any DMARDs
  • Without anticoagulant treatments or coagulation disease
  • With normal articular and enthesis sonography
  • For psoriatic arthritis patients :
  • Age over 18 years old
  • Signed informed consent
  • Psoriatic arthritis according to CASPAR criteria
  • Without any DMARDs
  • Without anticoagulant treatments or coagulation disease
  • With at least one synovitis at inclusion
  • For controls
  • Age and sex matched with a patient without any rheumatic or dermatologic medical conditions
  • No treatment with corticosteroïds or non-steroïdial anti-inflammatory drugsAge over 18 years old

Exclusion criteria

▪ For psoriasis patients :

  • Joint damage according to CASPAR criteria
  • Echography activity in favor of chronic inflammatory rheumatism
  • For patients and controls:
  • Without social protection rights
  • People under judiciary protection, of less than 18 years old, pregnant woman, breast feeding women, jailed patients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Chu Poitiers — Poitiers

Identifiers

NCT: NCT05307809 · CYNEPSA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗