Validation of the PsASon ULtrasound scores in patients with psoriatic arthritis undergoing TReatment with Apremilast

Medical University Graz; Department of Rheumatology and Immunology0 个研究点目标入组 0 人开始时间: 2019年5月13日最近更新: 2022年8月8日

试验速览

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•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 an DAPSA >14 and clinical indication for treatment with Apremilast (as per approved indication for PsA, including failure to respond to methotrexate)
•5.Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 31
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 31

•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.Change, including dosage changes or discontinuation, of csDMARD treatment in the last 4 weeks before baseline
•11.Current bDMARD, tsDMARD treatment
•12.Prior bDMARD or tsDMARD treatment without a minimal washout period before baseline (for drug specific minimal washout periods see Table 1)

发起方

Medical University Graz; Department of Rheumatology and Immunology