NCT04102449

Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Apremilast	Single arm receiving Apremilast and ultrasound examinations

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2019-09-25
• Last updated: 2021-05-13

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated drug study