The main purpose of this study is to validate the ultrasound scores PsASon22 and PsASon13 in patients with active psoriatic arthritis undergoing a treatment with Apremilast.
This is a prospective, multicentre, phase IV trial assessing the value of the ultrasound scores PsASon22 and PsASon13 in differentiating between clinically active and inactive patients with psoriatic arthritis, following a treatment with Apremilast for up to 24 months. Additionally, convergent construct validity, inter/intra-reader reliability, sensitivity to change and differences in change in certain patients will be tested for the ultrasound scores.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Single arm receiving Apremilast and ultrasound examinations
Medical University of Graz
Graz, Styria, Austria
The difference in the change-score of the PsASon22
The main outcome is the difference in the change-score of the PsASon22 between patients achieving low disease activity or remission (DAPSA≤14) and patients not achieving this target under a treatment with Apremilast. The Psoratic Arthritis Sonography Score 22, PsASon22 (range 0-260), is a sum score, including grey scale and power doppler measurements of 22 joints (6 MCPs, 4-H-PIPs, 2 MTPs, 4 H-DIPs, 2 F-DIPs, 4 large joints) and 4 entheses (lateral epicondyle and distal patella - bilateral), with a higher score presumably indicating higher disease activity.
Time frame: 4-12-24 months
The difference in the change-score of the PsASon13
The main outcome is the difference in the change-score of the PsASon13 between patients achieving low disease activity or remission (DAPSA≤14) and patients not achieving this target under a treatment with Apremilast. The Psoratic Arthritis Sonography Score 13, PsASon13 (range 0-134), is a sum score, including grey scale and power doppler measurements of 13 joints (2 MCPs, 3-H-PIPs, 1-F-PIP, 2 MTPs, 1 H-DIPs, 2 F-DIPs, 2 large joints) and 2 entheses (lateral epicondyle and distal patella - unilateral), with a higher score presumably indicating higher disease activity.
Time frame: 4-12-24 months
Convergent construct validity of PsAson22 and PsASon13
Convergent construct validity will be assessed by correlating the ultrasound scores to clinical composite scores (f.e. DAPSA)
Time frame: 4-12-24 months
Sensitivity to Change of PsASon22 and PsASon13
Sensitivity to change will be assessed by measuring the PsASon22 and PsASon 13 scores at four different time points (Baseline and after 4, 12 and 24 months)
Time frame: 4-12-24 months
Interrater reliability of PsASon22 and PsASon13
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Interrater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators
Time frame: 4-12-24 months
Intrarater reliability of PsASon22 and PsASon13
Intrarater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators
Time frame: 4-12-24 months
Differences in PsASon22 and PsASon13 change
Differences in change will be assessed by comparing the change scores of patients with initially high disease activity (DAPSA\>28) with the change scores of patients with initially moderate disease activity (DAPSA\>14-≤28)
Time frame: 4-12-24 months