Consecutive patients with PsA and with clinically active peripheral disease (arthritis, tenosynovitis, dactylitis and/or enthesitis)
Conditions
Interventions
Trade Name: Otezla
Product Name: Otezla
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: Apremilast
Other descriptive name: APREMI
Sponsors
Medical University Graz; Department of Rheumatology and Immunology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient =18 years and 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
Exclusion criteria
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. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the differences in change of PsASon22 and PsASon13 scores after treatment with Apremilast between patients reaching low disease activity or remission (DAPSA=14) and patients not reaching this target (DAPSA>14);Secondary Objective: 1. To test the convergent construct validity of PsASon22 and PsASon13 US scores by correlating them with clinical composite scores. 2. To test sensitivity to change of the PsASon22 and PsASon13 US scores, assessing them at multiple time points 3. To test the inter-reader and intra-reader reliability of the PsASon22 and PsASon13 US scores. 4. To test differences in the change of PsASon22 and PsASon13 scores in PsA patients with high (DAPSA>28) compared to moderate (DAPSA>14-=28) disease activity at baseline.;Primary end point(s): To test the change of PsASon22 and PsASon13 scores in PsA patients undergoing treatment with Apremilast wthin 24 weeks;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To test the convergent construct validity of PsASon22 and PsASon13 ultrasound scores by correlating them with clinical composite scores. 2. To test the reliability of the PsASon22 and PsASon13 ultrasound scores. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Austria, Germany
Contacts
Public ContactKKS
Medical Univerity Graz
Outcome results
None listed