A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
PREVAIL
Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)
2 other identifiers
observational
119
1 country
20
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedJune 5, 2024
June 1, 2024
2.7 years
October 24, 2018
June 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment persistence at 6 months after initiating apremilast treatment
Percentage of patients still being treated with apremilast after 6 months of initiating treatment
Up to approximately 6 months
Secondary Outcomes (17)
Demographic characteristics
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.
Up to approximately 12 months
To assess the persistence of apremilast treatment after 12 months of treatment start
Up to approximately 12 months
To assess the disease activity at 6 and 12 months of treatment with apremilast.
At 6 and 12 months
Changes on clinical enthesitis and dactilitis
UP to approximately 12 months
- +12 more secondary outcomes
Study Arms (1)
Psoriatic Arthritis patients on Apremilast
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Men and women older than 18 years.
- Patients diagnosed with psoriatic arthritis according to the CASPAR criteria\*.
- Patients naive to biologic treatments.
You may not qualify if:
- Patients who reject to sign the informed consent.
- Patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit or for the duration of apremilast treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (20)
H Son Espases
Mallorca, Balearic Islands, 07120b, Spain
H Son Llatzer
Mallorca, Balearic Islands, 07198, Spain
H Txagorritxu de Vitoria
Vitoria-Gasteiz, Basque Country, 01009, Spain
H Univ Canarias
Santa Cruz de Tenerife, Canary Islands, 38320, Spain
H Parc Tauli
Barcelona, Catalonia, 08208, Spain
H Bellvitge
L'Hospitalet Del Llobregat, Catalonia, 8907, Spain
H Santa Maria Lleida
Lleida, Catalonia, 25198, Spain
H Joan XXIII
Tarragona, Catalonia, 43005, Spain
H Mérida
Badajoz, Extremadura, 06800, Spain
H Virgen del Puerto
Cáceres, Extremadura, 10600, Spain
H Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
H Navarra
Pamplona, Navarre, 31008, Spain
H Perpetuo Socorro
Badajoz, 06010, Spain
H Del Mar
Barcelona, 08003, Spain
H Donostia
Donostia / San Sebastian, 20014, Spain
H Can Misses
Ibiza Town, 07800, Spain
H Santa Lucía
Murcia, 30202, Spain
H Monte Naranco
Oviedo, 33012, Spain
H l Esperit Sant
Santa Coloma de Gramenet, 08923, Spain
Universitaire Vaudoise*
Vigo, 36213, Spain
Related Publications (1)
Gratacos-Masmitja J, Beltran Catalan E, Alvarez Vega JL, Urruticoechea-Arana A, Fito C, Maceiras F, Belzunegui Otano JM, Fernandez Melon J, Chamizo Carmona E, Abad Hernandez MA, Ros Vilamajo I, Castro Oreiro S, Pascual Alfonso E, Torre Alonso JC; PREVAIL team. Real-world apremilast use in biologic-naive psoriatic arthritis patients. Data from Spanish clinical practice. Reumatol Clin (Engl Ed). 2024 Jan;20(1):24-31. doi: 10.1016/j.reumae.2023.09.004.
PMID: 38233009DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
February 4, 2019
Study Start
February 6, 2019
Primary Completion
October 20, 2021
Study Completion
October 20, 2021
Last Updated
June 5, 2024
Record last verified: 2024-06