Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast (PSA-ULTRA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment with Apremilast; Single group: Apremilast will be prescribed according to the patient information leaflet, i.e.: Dosage form: Oral pill Dosage and Frequency: First 6 days titration phase, followed by 30mg twice daily (in case of kidney problems 30mg once daily in the morning). Treatment duration at the discretion of the treating physician.	Drug: Apremilast; Single arm receiving Apremilast and ultrasound examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Medical University of Vienna; Celgene Corporation; Medical University Innsbruck
• Investigators: Principal Investigator: Rusmir Husic, Dr., Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Outcome measures; Apremilast; Psoriatic arthritis; Disease activity
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: AP-CL-PSA-PI-12856

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes