Mechanism of action study of Ustekinumab treatment in psoriatic arthritis: Impact on cellular and molecular pathways of synovial inflammation and tissue remodeling

Phase 4

Completed

Conditions: psoriatic arthritis
10023213
psoriatic arthropathy
10003816

Registration Number: NL-OMON47065

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Psoriatic artrhritis according to the CASPAR criteria
Active disease defined as SJC/TJC of 3 or more
Presence of knee and/or ankle arthritis in order to get synovial tissue biopsies
Is going to receive ustekinumab treatment for his/her psoriatic artrhitis

Exclusion Criteria

- Previous use of ustekinumab, il17blocking therapy or multiple TNF blocking therapy use
- Contra-indication for needle arthroscopy such as joint replacement surgery and anti-coagulation use (that can not be temporarily stopped)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- changes in the synovial cellular and molecular pathways as indicated in the<br /><br>objectives between baseline and week 12/24.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Stratification of these cellular and molecular changes according to the<br /><br>genetic biomarkers of relevance for ustekinumab treatment response<br /><br>- Correlation between the synovial features at baseline and the clinical<br /><br>response at week 12/24.<br /><br>- Comparison between the synovial features at baseline and the clinical<br /><br>response at week 12/24.<br /><br>- Comparison of the synovial molecular changes induced by ustekinumab therapy<br /><br>with the changes induced by anti-TNF (historical samples in a similar patient<br /><br>population and study setting)</p><br>