Apremilast and cardiometabolic effects
Recruiting
- Conditions
- Psoriatic arthritis (PsA)
- Registration Number
- NL-OMON19880
- Lead Sponsor
- Reade, outpatient rheumatology clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Adult (≥18 years) patients with active PsA
- Indication to start with apremilast (Otezla)
Exclusion Criteria
- Inability or unwillingness to sign informed consent
- Contraindication for apremilast (i.e. pregnancy and hypersensitivity to apremilast and/or its excipients)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Body composition =: this will be assessed using whole body DEXA, and body composition will be analyzed for whole-body and segmental lean soft tissue, fat mass and body fat percentage using DXA.
- Secondary Outcome Measures
Name Time Method - Height, weight, blood pressure, heart rate, abdominal wall and hip circumference<br /><br>- Presence of peripheral arthritis will be assessed by performing a 68 tender joint count and 66 swollen joint count<br /><br> - Patient pain, as reported on a visual analogue scale<br /><br> - Patient global assessment of disease activity as reported on a visual analogue scale<br /><br> - PASI<br /><br> - LEI<br /><br> - RAPID questionnaire<br /><br> - Laboratory investigations<br /><br> - Carotid intima media thickness (cIMT)<br /><br> - Dual energy CT-scanning (DECT-scan), at baseline and week 26, to determine the presence of atherosclerosis and plaque composition in large arteries<br>