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NCT Number: NCT03828045

A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment

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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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

H Son Espases, Mallorca, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apremilast

Drug

Apremilast

Primary outcomes

  1. Treatment persistence at 6 months after initiating apremilast treatment

    Time frame: Up to approximately 6 months

    Percentage of patients still being treated with apremilast after 6 months of initiating treatment

Secondary outcomes

  1. Demographic characteristics

    Time frame: Up to approximately 6 months

    Description of the demographic at time of initiating treatment with apremilast

  2. 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.

    Time frame: Up to approximately 12 months

    To capture the changes in dose and regimen of apremilast.

  3. To assess the persistence of apremilast treatment after 12 months of treatment start

    Time frame: Up to approximately 12 months

    Percentage of patients still being treated with apremilast after 12 months of initiating treatment

  4. To assess the disease activity at 6 and 12 months of treatment with apremilast.

    Time frame: 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.

  5. Changes on clinical enthesitis and dactilitis

    Time frame: UP to approximately 12 months

    Assessment of the changes on clinical enthesitis and dactilitis count after 6 and 12 months of treatment with apremilast.

  6. Tender joints count

    Time frame: Up to approximately 12 months

    Change from baseline in the joints deemed tender as per joint count assessment by physical exam.

  7. Swollen joints count

    Time frame: UP to approximately 12 months

    Change from baseline in the joints deemed tender as per joint count assessment by physical exam.

  8. Changes in the plasma concentration of C-reactive protein.

    Time frame: 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.

  9. Physician Global Assessment of Disease Activity (PGA).

    Time frame: Up to approximately 12 months

    Assessment of the Physician Global Assessment of Disease Activity (PGA) after 6 and 12 months of apremilast treatment.

  10. To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.

    Time frame: UP to approximately 12 months

    Joint erosion will be assessed radiologically, as regularly assessed in the routine practice of each center.

  11. The VITACORA-19 questionnaires

    Time frame: 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

  12. The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires

    Time frame: 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

  13. Assessment of changes on affected joints

    Time frame: Up to approximately 12 months

    Assessment of the changes on affected joints count after 6 and 12 months of treatment with apremilast.

  14. Assessment of DAPSA/cDAPSA scores

    Time frame: Up to approximately 12 months

    Assessment of the changes of the DAPSA/cDAPSA score at 6/12 month after treatment.

  15. To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.

    Time frame: 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

  16. Adverse events (AEs)

    Time frame: Up to approximately 12 months

    Number participants with adverse events.

  17. To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)

Acronym: PREVAIL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2019
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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