Arthritis, PsoriaticPREVAILNCT03828045
A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
An observational study of Arthritis, Psoriatic, run by Amgen at 20 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Apremilast
- How many people
- 119 participants
- Where
- 20 sitesSpain
- Study dates
- 6 Feb 2019to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
H Mérida
Badajoz, Extremadura, 06800
H Perpetuo Socorro
Badajoz, 06010
H Parc Tauli
Barcelona, Catalonia, 08208
H Del Mar
Barcelona, 08003
H Virgen del Puerto
Cáceres, Extremadura, 10600
H Donostia
Donostia / San Sebastian, 20014
H Virgen de la Arrixaca
El Palmar, Murcia, 30120
H Can Misses
Ibiza Town, 07800
H Bellvitge
L'Hospitalet Del Llobregat, Catalonia, 8907
H Santa Maria Lleida
Lleida, Catalonia, 25198
H Son Espases
Mallorca, Balearic Islands, 07120b
H Son Llatzer
Mallorca, Balearic Islands, 07198
H Santa Lucía
Murcia, 30202
H Monte Naranco
Oviedo, 33012
H Navarra
Pamplona, Navarre, 31008
H l Esperit Sant
Santa Coloma de Gramenet, 08923
H Univ Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
H Joan XXIII
Tarragona, Catalonia, 43005
Universitaire Vaudoise*
Vigo, 36213
H Txagorritxu de Vitoria
Vitoria-Gasteiz, Basque Country, 01009
About this study
Official title: 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.
Read more
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
- Conditions
- Arthritis, Psoriatic
- Being tested
- Apremilast
- Keywords
- Psoriatic Arthritis, Apremilast, CC-10004, Biologic Treatments
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Apremilast
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment persistence at 6 months after initiating apremilast treatment
Percentage of patients still being treated with apremilast after 6 months of initiating treatment
Measured: Up to approximately 6 months
Secondary outcomes (17)
Demographic characteristics
Description of the demographic at time of initiating treatment with apremilast
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: UP to approximately 12 months
Tender joints count
Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
Measured: Up to approximately 12 months
Swollen joints count
Change from baseline in the joints deemed tender as per joint count assessment by physical exam.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to approximately 12 months
Adverse events (AEs)
Number participants with adverse events.
Measured: 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.
Measured: UP to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start6 Feb 2019
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828045
- Sponsor's protocol ID
- CC-10004-PSA-015
- Other IDs
- U1111-1221-8638
- Acronym
- PREVAIL
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2018
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38233009
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)
- ClinicalTrials.gov ID
- NCT03828045
- Acronym / sponsor ID
- PREVAIL / CC-10004-PSA-015
- Conditions
- Arthritis, Psoriatic
- Keywords
- Psoriatic Arthritis, Apremilast, CC-10004, Biologic Treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis patients on Apremilast | – | Drug: ApremilastPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastApremilast | Drug | Psoriatic Arthritis patients on Apremilast |
Primary outcome
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
17 secondary outcomes
Demographic characteristics
Time frame: 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.
Time frame: Up to approximately 12 months
To assess the persistence of apremilast treatment after 12 months of treatment start
Time frame: Up to approximately 12 months
To assess the disease activity at 6 and 12 months of treatment with apremilast.
Time frame: At 6 and 12 months
Changes on clinical enthesitis and dactilitis
Time frame: UP to approximately 12 months
Tender joints count
Time frame: Up to approximately 12 months
Swollen joints count
Time frame: UP to approximately 12 months
Changes in the plasma concentration of C-reactive protein.
Time frame: Up to approximately 12 months
Physician Global Assessment of Disease Activity (PGA).
Time frame: Up to approximately 12 months
To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.
Time frame: UP to approximately 12 months
The VITACORA-19 questionnaires
Time frame: UP to approximately 12 months
The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires
Time frame: UP to approximately 12 months
Assessment of changes on affected joints
Time frame: Up to approximately 12 months
Assessment of DAPSA/cDAPSA scores
Time frame: 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.
Time frame: Up to approximately 12 months
Adverse events (AEs)
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.
Time frame: UP to approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 38233009Gratacos-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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic, run by Amgen at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment persistence at 6 months after initiating apremilast treatment (time frame: Up to approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.