Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- The difference in the change-score of the PsASon22
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patient ≥18 years and <90 years of age
- •PsA according to CASPAR criteria
- •Peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis)
- •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)
- •Written informed consent
Exclusion Criteria
- •Inability to perform US at any site included in the PsASon22 or PsASon13 score (f.e. due to complete destruction of a joint)
- •Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography.
- •Contraindication to Apremilast (as per patient information leaflet)
- •Current severe medical illness requiring hospitalization
- •Pregnancy or lactation
- •Inability of the patient to follow the treatment protocol
- •Fulfillment of the MDA Criteria or DAPSA≤14
- •Current treatment with any investigational drug
- •Current treatment with glucocorticoids at a prednisone equivalent >10mg
- •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
- •Change, including dosage changes or discontinuation, of csDMARD treatment (with the exception of leflunomide) in the last 4 weeks before baseline
- •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.)
- •Current bDMARD, tsDMARD treatment
- •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)
Arms & Interventions
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.
Intervention: Apremilast (Drug)
Outcomes
Primary Outcomes
The difference in the change-score of the PsASon22
Time Frame: 4-12-24 months
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.
The difference in the change-score of the PsASon13
Time Frame: 4-12-24 months
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.
Secondary Outcomes
- Convergent construct validity of PsAson22 and PsASon13(4-12-24 months)
- Sensitivity to Change of PsASon22 and PsASon13(4-12-24 months)
- Interrater reliability of PsASon22 and PsASon13(4-12-24 months)
- Intrarater reliability of PsASon22 and PsASon13(4-12-24 months)
- Differences in PsASon22 and PsASon13 change(4-12-24 months)