Status:
WITHDRAWN
Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Celgene Corporation
Medical University of Vienna
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04102449
Start Date
July 1 2020
End Date
February 1 2022
Last Update
May 13 2021
Active Locations (1)
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1
Medical University of Graz
Graz, Styria, Austria, 8010