Validation of the PsASon ULtrasound scores in patients with psoriatic arthritis undergoing TReatment with Apremilast

Phase 1

• Conditions: Consecutive patients with PsA and with clinically active peripheral disease (arthritis, tenosynovitis, dactylitis and/or enthesitis); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-001758-89-AT
• Lead Sponsor: Medical University Graz; Department of Rheumatology and Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Male or female patient =18 years and <90 years of age
2.PsA according to CASPAR criteria
3.Peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis)
4.Active disease as defined by an DAPSA >14 and clinical indication for treatment with Apremilast (as per approved indication for PsA, including failure to respond to methotrexate)
5.Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

1.Inability to perform US at any site included in the PsASon22 or PsASon13 score (f.e. due to complete destruction of a joint)
2.Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography.
3.Contraindication to Apremilast (as per patient information leaflet)
4.Current severe medical illness requiring hospitalization
5.Pregnancy or lactation
6.Inability of the patient to follow the treatment protocol
7.Fulfillment of the MDA Criteria or DAPSA=14
8.Current treatment with any investigational drug
9.Current treatment with glucocorticoids at a prednisone equivalent >10mg
10.Change, including dosage changes or discontinuation, of csDMARD treatment in the last 4 weeks before baseline
11.Current bDMARD, tsDMARD treatment
12.Prior bDMARD or tsDMARD treatment without a minimal washout period before baseline (for drug specific minimal washout periods see Table 1)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified