Clinical trial NCT04102449: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Official title: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Psoriatic Arthritis
Keywords: Ultrasound
Psoriatic arthritis
Outcome measures
Apremilast
Disease activity
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
name: Medical University of Vienna
name: Medical University Innsbruck
First posted: 2019-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The difference in the change-score of the PsASon22
timeFrame: 4-12-24 months
measure: The difference in the change-score of the PsASon13
timeFrame: 4-12-24 months
Secondary outcomes:
measure: Convergent construct validity of PsAson22 and PsASon13
timeFrame: 4-12-24 months
measure: Sensitivity to Change of PsASon22 and PsASon13
timeFrame: 4-12-24 months
measure: Interrater reliability of PsASon22 and PsASon13
timeFrame: 4-12-24 months
measure: Intrarater reliability of PsASon22 and PsASon13
timeFrame: 4-12-24 months
measure: Differences in PsASon22 and PsASon13 change
timeFrame: 4-12-24 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Rusmir Husic, Dr.
role: PRINCIPAL_INVESTIGATOR
References: