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

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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Apremilast

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06010
    • H Perpetuo Socorro
  • Barcelona, Spain, 08003
    • H Del Mar
  • Donostia, Spain, 20014
    • H Donostia
  • Eivissa, Spain, 07800
    • H Can Misses
  • Murcia, Spain, 30202
    • H Santa Lucía
  • Oviedo, Spain, 33012
    • H Monte Naranco
  • Santa Coloma de Gramenet, Spain, 08923
    • H l Esperit Sant
  • Vigo, Spain, 36213
    • Universitaire Vaudoise*
  • Baleares
    • Mallorca, Baleares, Spain, 07120b
      • H Son Espases
    • Mallorca, Baleares, Spain, 07198
      • H Son Llatzer
  • Canarias
    • Tenerife, Canarias, Spain, 38320
      • H Univ Canarias
  • Cataluña
    • Barcelona, Cataluña, Spain, 08208
      • H Parc Tauli
    • L'Hospitalet Del Llobregat, Cataluña, Spain, 8907
      • H Bellvitge
    • Lérida, Cataluña, Spain, 25198
      • H Santa Maria Lleida
    • Tarragona, Cataluña, Spain, 43005
      • H Joan XXIII
  • Extremadura
    • Badajoz, Extremadura, Spain, 06800
      • H Mérida
    • Caceres, Extremadura, Spain, 10600
      • H Virgen del Puerto
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • H Virgen de la Arrixaca
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • H Navarra
  • País Vasco
    • Vitoria, País Vasco, Spain, 01009
      • H Txagorritxu de Vitoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Apremilast; Apremilast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; CC-10004; Apremilast; Biologic Treatments
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: CC-10004-PSA-015; U1111-1221-8638 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No