A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
- Registration Number
- NCT03828045
- Lead Sponsor
- Amgen
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Psoriatic Arthritis patients on Apremilast 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.
- Primary Outcome Measures
Name Time Method Treatment persistence at 6 months after initiating apremilast treatment Up to approximately 6 months Percentage of patients still being treated with apremilast after 6 months of initiating treatment
- Secondary Outcome Measures
Name Time Method To assess the disease activity at 6 and 12 months of treatment with apremilast. At 6 and 12 months The disease activity will be assessed by the DAPSA scale when the information available in the patient's medical record allows the estimation of the DAPSA score. Otherwise, the individual items of the DAPSA scale will be described separately.
Changes on clinical enthesitis and dactilitis UP to approximately 12 months Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast.
Tender joints count Up to approximately 12 months Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
Swollen joints count UP to approximately 12 months Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
Physician Global Assessment of Disease Activity (PGA). Up to approximately 12 months Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment.
The VITACORA-19 questionnaires UP to approximately 12 months are used to assess the health-related quality of life of patients with PsA in the setting of clinical trials
Demographic characteristics Up to approximately 6 months Description of the demographic at time of initiating treatment with apremilast
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 capture the changes in dose and regimen of apremilast.
To assess the persistence of apremilast treatment after 12 months of treatment start Up to approximately 12 months Percentage of patients still being treated with apremilast after 12 months of initiating treatment
Assessment of changes on affected joints Up to approximately 12 months Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast.
Changes in the plasma concentration of C-reactive protein. Up to approximately 12 months Assessment of the change in the plasma concentration of C-reactive protein after 6 and 12 months of apremilast treatment.
To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast. UP to approximately 12 months Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center.
The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires UP to approximately 12 months was developed under a 13-country EULAR initiative to evaluate the impact of psoriatic arthritis in clinical practice . The version used in this study (PsAID-9) consists of 9 items addressing pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleeping disturbances, coping, and anxiety
Adverse events (AEs) Up to approximately 12 months Number participants with adverse events.
Assessment of DAPSA/cDAPSA scores Up to approximately 12 months Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment.
To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. Up to approximately 12 months Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. The Pearson or Spearman correlation will be performed to evaluate the relationship between these variables
To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. UP to approximately 12 months To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. Assessment of the relationship between the count of affected joints at treatment start and the DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.
Trial Locations
- Locations (20)
Universitaire Vaudoise*
🇪🇸Vigo, Spain
H Univ Canarias
🇪🇸Tenerife, Canarias, Spain
H Parc Tauli
🇪🇸Barcelona, Cataluña, Spain
H Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
H Navarra
🇪🇸Pamplona, Navarra, Spain
H Son Llatzer
🇪🇸Mallorca, Baleares, Spain
H Del Mar
🇪🇸Barcelona, Spain
H Son Espases
🇪🇸Mallorca, Baleares, Spain
H Bellvitge
🇪🇸L'Hospitalet Del Llobregat, Cataluña, Spain
H Santa Maria Lleida
🇪🇸Lérida, Cataluña, Spain
H Virgen del Puerto
🇪🇸Caceres, Extremadura, Spain
H Joan XXIII
🇪🇸Tarragona, Cataluña, Spain
H Perpetuo Socorro
🇪🇸Badajoz, Spain
H Txagorritxu de Vitoria
🇪🇸Vitoria, País Vasco, Spain
H Can Misses
🇪🇸Eivissa, Spain
H Santa Lucía
🇪🇸Murcia, Spain
H Monte Naranco
🇪🇸Oviedo, Spain
H Donostia
🇪🇸Donostia, Spain
H l Esperit Sant
🇪🇸Santa Coloma de Gramenet, Spain
H Mérida
🇪🇸Badajoz, Extremadura, Spain