Clinical trial NCT03828045: A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
Official title: Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Keywords: Psoriatic Arthritis
Apremilast
CC-10004
Biologic Treatments
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-02-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: Inclusion Criteria:

* Men and women older than 18 years.
* Patients diagnosed with psoriatic arthritis according to the CASPAR criteria\*.
* Patients who, following the routine clinical practice, initiated treatment with apremilast 6 months (±4 weeks) before their inclusion in the study.
* Patients naive to biologic treatments.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Treatment persistence at 6 months after initiating apremilast treatment
timeFrame: Up to approximately 6 months
Secondary outcomes:
measure: Demographic characteristics
timeFrame: Up to approximately 6 months
measure: 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
measure: To assess the persistence of apremilast treatment after 12 months of treatment start
timeFrame: Up to approximately 12 months
measure: To assess the disease activity at 6 and 12 months of treatment with apremilast.
timeFrame: At 6 and 12 months
measure: Changes on clinical enthesitis and dactilitis
timeFrame: UP to approximately 12 months
measure: Tender joints count
timeFrame: Up to approximately 12 months
measure: Swollen joints count
timeFrame: UP to approximately 12 months
measure: Changes in the plasma concentration of C-reactive protein.
timeFrame: Up to approximately 12 months
measure: Physician Global Assessment of Disease Activity (PGA).
timeFrame: Up to approximately 12 months
measure: To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.
timeFrame: UP to approximately 12 months
measure: The VITACORA-19 questionnaires
timeFrame: UP to approximately 12 months
measure: The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires
timeFrame: UP to approximately 12 months
measure: Assessment of changes on affected joints
timeFrame: Up to approximately 12 months
measure: Assessment of DAPSA/cDAPSA scores
timeFrame: Up to approximately 12 months
measure: 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
measure: Adverse events (AEs)
timeFrame: Up to approximately 12 months
measure: 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
Other outcomes:
Locations:
city: Mallorca
country: Spain
facility: H Son Espases
state: Baleares
city: Mallorca
country: Spain
facility: H Son Llatzer
state: Baleares
city: Tenerife
country: Spain
facility: H Univ Canarias
state: Canarias
city: Barcelona
country: Spain
facility: H Parc Tauli
state: Cataluña
city: L'Hospitalet Del Llobregat
country: Spain
facility: H Bellvitge
state: Cataluña
city: Lérida
country: Spain
facility: H Santa Maria Lleida
state: Cataluña
city: Tarragona
country: Spain
facility: H Joan XXIII
state: Cataluña
city: Badajoz
country: Spain
facility: H Mérida
state: Extremadura
city: Caceres
country: Spain
facility: H Virgen del Puerto
state: Extremadura
city: El Palmar
country: Spain
facility: H Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: H Navarra
state: Navarra
city: Vitoria
country: Spain
facility: H Txagorritxu de Vitoria
state: País Vasco
city: Badajoz
country: Spain
facility: H Perpetuo Socorro
city: Barcelona
country: Spain
facility: H Del Mar
city: Donostia
country: Spain
facility: H Donostia
city: Eivissa
country: Spain
facility: H Can Misses
city: Murcia
country: Spain
facility: H Santa Lucía
city: Oviedo
country: Spain
facility: H Monte Naranco
city: Santa Coloma de Gramenet
country: Spain
facility: H l Esperit Sant
city: Vigo
country: Spain
facility: Universitaire Vaudoise*
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: