Arthritis, Psoriatic
Conditions
Keywords
Psoriatic Arthritis, Apremilast, CC-10004, Biologic Treatments
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
Interventions
DRUGApremilast
Apremilast
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
| Demographic characteristics | Up to approximately 6 months | Description of the demographic at time of initiating treatment with apremilast |
| 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 |
| 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. |
| 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 |
| Adverse events (AEs) | Up to approximately 12 months | Number participants with adverse events. |
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed