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

Psoriatic Arthritis Clinical Trial

— PSA-ULTRA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04102449
• Other study ID #: AP-CL-PSA-PI-12856
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: February 2022

Study information

• Verified date: May 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 a DAPSA >14 and clinical indication for treatment with Apremilast (as per approved indication for PsA, including failure to methotrexate)

5. Written informed consent

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. Intra-articular glucocorticoid injection in one of the joints to be investigated clinically or by sonography, or intra-muscular glucocorticoid injection within 8 weeks before baseline

11. Change, including dosage changes or discontinuation, of csDMARD treatment (with the exception of leflunomide) in the last 4 weeks before baseline

12. Change, including dosage changes or discontinuation of leflunomide treatment in the last 8 weeks before baseline. (Exception: If patients stop leflunomide and complete an 11 day treatment with cholestyramine (8g, 3 x daily), prior to the baseline visit, they may enter the study.)

13. Current bDMARD, tsDMARD treatment

14. Prior bDMARD or tsDMARD treatment without a minimal washout period before baseline (the minimal washout period is twice the half-life of the respective drug)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Apremilast
Single arm receiving Apremilast and ultrasound examinations

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of Graz	Celgene Corporation, Medical University Innsbruck, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-12-24 months
Primary	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.	4-12-24 months
Secondary	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)	4-12-24 months
Secondary	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)	4-12-24 months
Secondary	Interrater reliability of PsASon22 and PsASon13	Interrater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators	4-12-24 months
Secondary	Intrarater reliability of PsASon22 and PsASon13	Intrarater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators	4-12-24 months
Secondary	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)	4-12-24 months