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

Primary Purpose

Psoriasis, Psoriatic Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
Skin sample collection
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chu PoitiersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Psoriasis

Psoriatic arthritis

Controls

Arm Description

Outcomes

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
Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups

Secondary Outcome Measures

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
Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity
Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity

Full Information

First Posted
March 23, 2022
Last Updated
November 30, 2022
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05307809
Brief Title
Cytokine Expression in Psoriasis Patients With and Without Joint Involvement
Acronym
CYNEPSA
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
August 17, 2024 (Anticipated)
Study Completion Date
August 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psoriasis
Arm Type
Experimental
Arm Title
Psoriatic arthritis
Arm Type
Experimental
Arm Title
Controls
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
Blood sample collection
Intervention Type
Other
Intervention Name(s)
Skin sample collection
Intervention Description
Skin sample collection
Primary Outcome Measure Information:
Title
Comparison of cytokine levels in sera, after culture of PBMC stimulated with LPS or CD3/CD28 agonist antibodies between the three groups
Description
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 Measure Information:
Title
Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients
Description
Comparison of cytokine levels in skin biopsies between Psoriatic Arthritis and Cutaneous Psoriasis patients
Time Frame
At inclusion
Title
Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity
Description
Correlation of cytokine levels with rheumatologic disease activity, or dermatologic disease activity
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume LARID
Phone
+33549444465
Email
rhumatologie@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume LARID
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GUILLAUME LARID, DR

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Cytokine Expression in Psoriasis Patients With and Without Joint Involvement

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