Psoriatic Arthritis
Conditions
Interventions
Group 1: 100 Patients with Psoriatic Arthritis (HR-pQCT examination)
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Adult male or female subject; age =18 3) Fulfillment of the CASPAR PsA criteria 4) Number of swollen joints =2 5) Disease duration < 5 years
Exclusion criteria
Exclusion criteria: 1) Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener 2) Concomitant florid immune mediated disease such as autoimmune hepatitis that is untreated and/or requires immunosuppressive treatment. 3) Nursing mother or pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and volume of erosions assessed by HR-pQCT at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Endpoints: -Number of swollen and tender joints (66/68) -Number of tender entheseal points (SPARCC, LEI) -Dactylitis counts -Activity of psoriasis (PASI, BSA) -Activity of axial involvement (BASDAI) -Quality of life and health/disability (PsAID-12, DLQI) Pain (Pain-VAS) -Subject´s and physician´s global assessment of disease activity (PGA-VAS and PhGA-VAS) -Subject´s assessment of skin disease activity (Skin-VAS) -Composite disease activity (Minimal Disease Activity (MDA), DAPSA, PASDAS) -Change of quality of life and disability (HAQ-DI) HR-pQCT Imaging endpoints: -Change in number and volume of bone erosions -Change in total volumetric bone density (D100), trabecular bone density (Trab.BMD), cortical bone density (Dcomp) assessed by by HR-pQCT -Change in number of structural entheseal lesions (SEL) assessed by by HR-pQCT -Correlation of fracture events over 12 months to changes in biomechanical properties -Change in the estimated fracture risk by HR-pQCT data | — |
Countries
Germany
Contacts
Public ContactFilippo Fagni
Universitätsklinikum Erlangen
Outcome results
None listed