NCT05307809

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2022Aug 2026

First Submitted

Initial submission to the registry

March 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 17, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2026

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

March 23, 2022

Last Update Submit

May 21, 2026

Conditions

PsoriasisPsoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    At inclusion

Study Arms (3)

Psoriasis

EXPERIMENTAL
Other: Blood sample collectionOther: Skin sample collection

Psoriatic arthritis

EXPERIMENTAL
Other: Blood sample collectionOther: Skin sample collection

Controls

ACTIVE COMPARATOR
Other: Blood sample collection

Interventions

Blood sample collectionOTHER

Blood sample collection

ControlsPsoriasisPsoriatic arthritis
Skin sample collectionOTHER

Skin sample collection

PsoriasisPsoriatic arthritis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For psoriasis patients :
  • Age over 18 years old
  • Signed informed consent
  • 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
  • +3 more criteria

You may not qualify if:

  • â–ª 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Guillaume LARID

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume LARID

CONTACT

+33549444465rhumatologie@chu-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 1, 2022

Study Start

August 17, 2022

Primary Completion (Estimated)

August 17, 2026

Study Completion (Estimated)

August 18, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Publication of the results

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Results will be published in a scientific journal
Access Criteria
Upon reasonable request to authors after article publication

Locations

FR(1)