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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05307809
Other study ID # CYNEPSA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2022
Est. completion date August 18, 2024

Study information

Verified date January 2024
Source Poitiers University Hospital
Contact Guillaume LARID
Phone +33549444465
Email rhumatologie@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 18, 2024
Est. primary completion date August 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sample collection
Blood sample collection
Skin sample collection
Skin sample collection

Locations

Country Name City State
France Chu Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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