Development and validation of an epigenetic biomarker that predicts treatment success and allows personalized management in rheumatoid arthritis and psoriasis

• Conditions: psoriasis; rheumatoid arthritis (rheumatoid); 10003816; 10013361; 10014982

• Registration Number: NL-OMON56905
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- Diagnosis of rheumatoid arthritis or psoriasis
- Active symptomatic disease
- Indication for biologic treatment with adalimumab (both), tocilizumab (RA),
abatacept (RA), ustekinumab (PsO) or secukinumab (PsO)

Exclusion Criteria

- Any condition which, in the opinion of the investigator, may interfere with
the patient's ability to comply with study procedures
- Received any investigational drug or another biologic in last month

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Clinical efficacy will be measured according to routine care. Percentage of<br /><br>patients meeting established and validated endpoints for good treatment<br /><br>response: clinical disease activity index (CDAI) <10.1 and *CDAI>=50% at Week 12<br /><br>for RA and Absolute Psoriasis Area and Severity Index (PASI) score <=2 at Week<br /><br>26 for PsO will be calculated. Epigenetic patterns of predictor CpGs associated<br /><br>with treatment response will be established.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>