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Apremilast and cardiometabolic effects

A prospective study on the cardio-metabolic effects of apremilast in patients with psoriatic arthritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON19880
Enrollment
50
Registered
2018-05-16
Start date
2017-01-18
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic arthritis (PsA)

Interventions

Sponsors

Reade, outpatient rheumatology clinic
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Adult (≥18 years) patients with active PsA - Indication to start with apremilast (Otezla)

Exclusion criteria

Exclusion criteria: - Inability or unwillingness to sign informed consent - Contraindication for apremilast (i.e. pregnancy and hypersensitivity to apremilast and/or its excipients)

Design outcomes

Primary

MeasureTime frame
- 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

MeasureTime frame
- Height, weight, blood pressure, heart rate, abdominal wall and hip circumference - Presence of peripheral arthritis will be assessed by performing a 68 tender joint count and 66 swollen joint count - Patient pain, as reported on a visual analogue scale - Patient global assessment of disease activity as reported on a visual analogue scale - PASI - LEI - RAPID questionnaire - Laboratory investigations - Carotid intima media thickness (cIMT) - Dual energy CT-scanning (DECT-scan), at baseline and week 26, to determine the presence of atherosclerosis and plaque composition in large arteries

Contacts

Public ContactM.T. Nurmohamed

Jan van Breemen Research Institute | Reade Postbus 58271

+31 020 242 1000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)