Prospective follow-up study of ustekinumab treatment in psoriatic arthritis

Phase 4

Recruiting

• Conditions: psoriatic arthritis; rheumatic disease; 10023213

• Registration Number: NL-OMON40967
• Lead Sponsor: Jan van Breemen Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients:
- who are diagnosed with psoriatic arthritis;
- in whom ustekinumab is prescribed by their treating rheumatologist; and
- who gave written informed consent.
Both biological naive patients as patients who failed on TNF-blocking agents are included.

Exclusion Criteria

Patients with contraindications for ustekinumab treatment.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- DAS28 score and response is defined as the EULAR criteria of a good or<br /><br>moderate response and a score of <3.2<br /><br>- PASI response<br /><br>- Effect on HAQ-DI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The number of adverse events (infections, malignancies, mortality)<br /><br>- LEI improvement<br /><br>- Number of nails with nail psoriasis<br /><br>- ESR and/or CRP<br /><br>- The lipid profile<br /><br>- Inflammation processes<br /><br>- Relation between genetic polymorphisms and the efficacy of ustekinumab<br /><br>- Radiographic progression<br /><br>- Changes in bone mineral density<br /><br>- Cardiovascular risk factors</p><br>