NCT03828045

A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment

Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 119 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast

Timeline

• Start date: 2019-02-06
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2019-02-04
• Last updated: 2024-06-05

Locations

20 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study