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Cytokine Expression in Psoriasis Patients With and Without Joint Involvement

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05307809
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Poitiers University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Guillaume LARID
Principal Investigator Affiliation Poitiers University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Psoriasis

Experimental: Psoriatic arthritis

Active Comparator: Controls

Interventions

Other: - Blood sample collection

Blood sample collection

Other: - Skin sample collection

Skin sample collection

Contact a Trial Team

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International Sites

Chu Poitiers, Poitiers, France

Status

Recruiting

Address

Chu Poitiers

Poitiers, ,

Site Contact

GUILLAUME LARID, DR

rhumatologie@chu-poitiers.fr

+33549444465

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