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

Arthritis, Psoriatic Clinical Trial

— PREVAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828045
• Other study ID #: CC-10004-PSA-015
• Secondary ID: U1111-1221-8638
• Status: Completed
• Start date: February 6, 2019
• Est. completion date: October 20, 2021

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Apremilast
Apremilast

Locations

Country	Name	City	State
Spain	H Mérida	Badajoz	Extremadura
Spain	H Perpetuo Socorro	Badajoz
Spain	H Del Mar	Barcelona
Spain	H Parc Tauli	Barcelona	Cataluña
Spain	H Virgen del Puerto	Caceres	Extremadura
Spain	H Donostia	Donostia
Spain	H Can Misses	Eivissa
Spain	H Virgen de la Arrixaca	El Palmar	Murcia
Spain	H Bellvitge	L'Hospitalet Del Llobregat	Cataluña
Spain	H Santa Maria Lleida	Lérida	Cataluña
Spain	H Son Espases	Mallorca	Baleares
Spain	H Son Llatzer	Mallorca	Baleares
Spain	H Santa Lucía	Murcia
Spain	H Monte Naranco	Oviedo
Spain	H Navarra	Pamplona	Navarra
Spain	H l Esperit Sant	Santa Coloma de Gramenet
Spain	H Joan XXIII	Tarragona	Cataluña
Spain	H Univ Canarias	Tenerife	Canarias
Spain	Universitaire Vaudoise*	Vigo
Spain	H Txagorritxu de Vitoria	Vitoria	País Vasco

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic characteristics	Description of the demographic at time of initiating treatment with apremilast	Up to approximately 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tender joints count	Change from baseline in the joints deemed tender as per joint count assessment by physical exam.	Up to approximately 12 months
Secondary	Swollen joints count	Change from baseline in the joints deemed tender as per joint count assessment by physical exam.	UP to approximately 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events (AEs)	Number participants with adverse events.	Up to approximately 12 months
Secondary	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

External Links

•   AmgenTrials clinical trials website