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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1221-8638 | Registry Identifier | WHO |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Apremilast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics | Description of the demographic at time of initiating treatment with apremilast | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Son Espases | Mallorca | Balearic Islands | 07120b | Spain | ||
| H Son Llatzer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38233009 | Derived | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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To capture the changes in dose and regimen of apremilast. |
| Up to approximately 12 months |
| To assess the persistence of apremilast treatment after 12 months of treatment start | Percentage of patients still being treated with apremilast after 12 months of initiating treatment | Up to approximately 12 months |
| To assess the disease activity at 6 and 12 months of treatment with apremilast. | 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. | At 6 and 12 months |
| Changes on clinical enthesitis and dactilitis | Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast. | UP to approximately 12 months |
| Tender joints count | Change from baseline in the joints deemed tender as per joint count assessment by physical exam. | Up to approximately 12 months |
| Swollen joints count | Change from baseline in the joints deemed tender as per joint count assessment by physical exam. | UP to approximately 12 months |
| Changes in the plasma concentration of C-reactive protein. | Assessment of the change in the plasma concentration of C-reactive protein after 6 and 12 months of apremilast treatment. | Up to approximately 12 months |
| Physician Global Assessment of Disease Activity (PGA). | Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment. | Up to approximately 12 months |
| To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast. | Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center. | UP to approximately 12 months |
| The VITACORA-19 questionnaires | are used to assess the health-related quality of life of patients with PsA in the setting of clinical trials | UP to approximately 12 months |
| The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires | 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 | UP to approximately 12 months |
| Assessment of changes on affected joints | Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast. | Up to approximately 12 months |
| Assessment of DAPSA/cDAPSA scores | Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment. | Up to approximately 12 months |
| To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast. | 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 | Up to approximately 12 months |
| Adverse events (AEs) | Number participants with adverse events. | Up to approximately 12 months |
| To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment. | 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. | UP to approximately 12 months |
| 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 |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C505730 | apremilast |
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