A study to evaluate the use of Apremilast in patients with Psoriatic Arthritis, Naïve to Biological treatmentPREVAIL
Study Details
Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology.
The study will include patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have – following the routine practice in their centers – initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.
Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study, which will not occur earlier than 6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy will be made independently by the physician.
Before entering the study, all patients shall sign an informed consent to participate in the study, including permission to retrieve data from their medical records and to complete questionnaires regarding their quality of life.
To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all consecutive patients who attend to a routine follow-up visit and have been prescribed apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection
Protocol Summary
Treatment persistence at 6 months after initiating apremilast treatment
Timeframe: Up to approximately 6 months
Demographic characteristics
Timeframe: Up to approximately 6 months
To describe the characteristics of apremilast treatment (i.e., dosage and regimen) in patients with PsA who start treatment according to the routine clinical practice.
Timeframe: Up to approximately 12 months
To assess the persistence of apremilast treatment after 12 months of treatment start
Timeframe: Up to approximately 12 months
To assess the disease activity at 6 and 12 months of treatment with apremilast.
Timeframe: At 6 and 12 months
Changes on clinical enthesitis and dactilitis
Timeframe: UP to approximately 12 months
Tender joints count
Timeframe: Up to approximately 12 months
Swollen joints count
Timeframe: UP to approximately 12 months
Changes in the plasma concentration of C-reactive protein.
Timeframe: Up to approximately 12 months
Physician Global Assessment of Disease Activity (PGA).
Timeframe: Up to approximately 12 months
To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.
Timeframe: UP to approximately 12 months
The VITACORA-19 questionnaires
Timeframe: UP to approximately 12 months
The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires
Timeframe: UP to approximately 12 months
Assessment of changes on affected joints
Timeframe: Up to approximately 12 months
Assessment of DAPSA/cDAPSA scores
Timeframe: Up to approximately 12 months
To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.
Timeframe: Up to approximately 12 months
Adverse events (AEs)
Timeframe: Up to approximately 12 months
To assess the changes in patient’s assessment of disease activity after 6 and 12 months of apremilast treatment.
Timeframe: UP to approximately 12 months