Cytokine Expression in Psoriasis Patients With and Without Joint Involvement (CYNEPSA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Other: Blood sample collection; Other: Skin sample collection

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume LARID; Phone Number: +33549444465; Email: rhumatologie@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France
    • Recruiting
    • CHU Poitiers
    • Contact: GUILLAUME LARID, DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psoriasis	Other: Blood sample collection; Blood sample collection; Other: Skin sample collection; Skin sample collection
Experimental: Psoriatic arthritis	Other: Blood sample collection; Blood sample collection; Other: Skin sample collection; Skin sample collection
Active Comparator: Controls	Other: Blood sample collection; Blood sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups	Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients	Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients	At inclusion
Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity	Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity	At inclusion

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Guillaume LARID, Poitiers university hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): August 17, 2024
• Study Completion (Estimated): August 18, 2024

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: CYNEPSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication of the results
• IPD Sharing Time Frame: Results will be published in a scientific journal
• IPD Sharing Access Criteria: Upon reasonable request to authors after article publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No