Psoriatic ArthritisAPROACHNCT03780504
Apremilast in Psoriatic Arthritis in Real-life Clinical Practice in Greece
An observational study of Psoriatic Arthritis, run by Genesis Pharma S.A. at 1 site in Greece.
Trial summary
Following the evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 170 participants
- Where
- 1 siteGreece
- Study dates
- 15 Apr 2019to 31 Dec 2022
- 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: The study population is adult biologic-naïve PsA patients, diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy, and who have prescribed treatment with apremilast according to the routine primary care settings of Greece.
Who may be able to join
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Male or female outpatients ≥18 years of age at the time of apremilast treatment onset;
- Patients diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy;
- Patients who have been prescribed treatment with apremilast (Otezla®) for PsA, either as a monotherapy or combination therapy with classical systemic DMARD, prior to signed Informed Consent and for whom, if treatment has started, no more than one week has elapsed from treatment initiation to obtaining the signed Informed Consent;
- Patients for whom the decision to prescribe therapy with apremilast according to the locally approved SmPC has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study;
- Patients with available information on the measures needed for the calculation of cDAPSA score at the start of apremilast treatment (i.e., number of swollen and tender joints based on the 66 swollen joint count and the 68 tender joint count, respectively, and patient global assessments of disease activity and pain);
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- Patients must be able to read, understand and complete the study specific questionnaires;
- Patients must provide a written Informed Consent prior to inclusion to the study;
- Patients must be able to understand the study procedures and adhere to the study visit schedule.
Who cannot join
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Patients who have a history of exposure to biologic treatment and/or to tofacitinib in PsA;
- Patients that meet any of the contraindications to the administration of the apremilast as outlined in the latest version of the locally approved SmPC;
- Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the start of therapy with apremilast;
- Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional Prospective Observational Study Assessing APRemilast in psOriatic Arthritis in Real-life Clinical Practice in Greek Healthcare Environment. The "APROACH" Study
Following the evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice. The present study primarily aims to generate real-world evidence on the impact of apremilast treatment on a broad population of biologic-naïve PsA patients in terms of its clinical effectiveness across the wide spectrum of disease manifestations, as well as its impact on disease burden and HRQoL, in the routine primary care settings of Greece.
Read the detailed description
Despite tremendous progress achieved in psoriatic arthritis (PsA) over the past 15 years, its management remains challenging due to the clinical heterogeneity and multifaceted nature of the disease. Currently available recommended algorithms for PsA treatment guide clinicians through treatment choices, beginning with conventional synthetic DMARDs after failure of non-steroidal anti-inflammatory drugs (NSAIDs) and local therapy for active disease, followed, if necessary, by a biological DMARD or a targeted synthetic (ts) DMARD. The latter novel category of DMARDs represents recent advances in the treatment options of PsA that aim to overcome the limitations of biological agents that stem by the fact that they have to be administered intravenously or subcutaneously, are very cost intensive for both the patients and the health system, while among them, the immunosuppressive biological agents are also associated with increased risks for infections and certain malignancies. The first approved tsDMARD for the treatment of PsA is apremilast which with an alternative mechanism of action, oral route of administration and favorable safety profile, presents a novel treatment option for PsA that may be appropriate for use early in the treatment algorithm.
Although there is evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, and despite the increasing recognition of the value of real-world data as a complementary source to randomized clinical trials, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice which is partially attributed to the relatively recent advent of apremilast in the market.
In light of the above, the present study primarily aims to generate real-world evidence on the impact of apremilast treatment on a broad population of biologic-naïve PsA patients in terms of its clinical effectiveness across the wide spectrum of disease manifestations, as well as its impact on disease burden and HRQoL, in the routine primary care settings of Greece. This information alongside with collected evidence regarding drug utilisation and safety profile under real-world conditions will strengthen the current state of knowledge in regards to the optimal use of apremilast in this population.
- Conditions
- Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the apremilast impact on peripheral PsA disease activity
Percentage of patients with active PsA treated with apremilast who will achieve at least 50% improvement in cDAPSA (clinical Disease Activity in Psoriatic Arthritis) baseline score at 24 weeks post-treatment onset
Measured: at 24 weeks post-treatment onset
Secondary outcomes (10)
estimate the moderate cDAPSA response rate
Percentage of patients with active PsA treated with apremilast who will achieve at least 75% improvement in cDAPSA (clinical Disease Activity in Psoriatic Arthritis) baseline score at 24 weeks and at 52 weeks post-treatment onset, respectively
Measured: at 24 and 52 weeks post-treatment onset
estimate the major cDAPSA response rate
Percentage of patients with active PsA treated with apremilast who will achieve at least 85% improvement in cDAPSA ( (clinical Disease Activity in Psoriatic Arthritis) baseline score at 24 weeks and at 52 weeks post-treatment onset, respectively
Measured: at 24 and 52 weeks post-treatment onset
classify the study population into the PsA disease activity states
Percentage of patients in remission (REM), low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA) at 52 weeks post-treatment onset, as assessed by DAPSA (Disease Activity in Psoriatic Arthritis) scores, using the cut-off values of ≤4 for REM, >4 and ≤14 for LDA, >14 and ≤28 for MDA and >28 for HDA
Measured: at 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on enthesitis (complete resolution)
Percentage of patients with enthesitis at baseline who will achieve complete resolution of enthesitis (LEI=0), as assessed by LEI (Leeds Enthesitis Index) score (0-6).
Measured: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on enthesitis (change in LEI score)
Change from baseline in LEI score among the study subpopulation with baseline LEI greater than zero
Measured: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on dactylitis (complete resolution)
Percentage of patients with dactylitis at baseline who will achieve complete resolution of dactylitis (DSS=0), as assessed by the dactylitis severity score (DSS 0-60 for all digits).
Measured: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on dactylitis (change from baseline)
Change from baseline in DSS among the study subpopulation with baseline DSS greater than zero.
Measured: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on dactylitis (change in digits)
Change from baseline in total number of digits affected by dactylitis among the study subpopulation with dactylitis at baseline.
Measured: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on patients' physical function using the HAQ-DI (change from baseline)
Change from baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) score among the overall study population.
Measured: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on patients' physical function using the HAQ-DI (percentage of patients)
Percentage of patients with HAQ-DI response among the overall study population )(HAQ-DI score: 0-3)
Measured: at 16, 24 and 52 weeks post-treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Apr 2019
- Primary completion20 Jul 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikos Antonakopoulos, MD, Study director, Genesis Pharma S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780504
- Sponsor's protocol ID
- GEN-NIS-APR-002
- Acronym
- APROACH
- Status last verified
- Dec 2021
- First submitted
- 17 Dec 2018
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Prospective Observational Study Assessing APRemilast in psOriatic Arthritis in Real-life Clinical Practice in Greek Healthcare Environment. The "APROACH" Study
- ClinicalTrials.gov ID
- NCT03780504
- Acronym / sponsor ID
- APROACH / GEN-NIS-APR-002
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Genesis Pharma S.A.Industry (pharma, biotech, devices)
- Collaborators
- Celgene, Amgen
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Dec 2018 (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.
Following the evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice. The present study primarily aims to generate real-world evidence on the impact of apremilast treatment on a broad population of biologic-naïve PsA patients in terms of its clinical effectiveness across the wide spectrum of disease manifestations, as well as its impact on disease burden and HRQoL, in the routine primary care settings of Greece.
Detailed description
Despite tremendous progress achieved in psoriatic arthritis (PsA) over the past 15 years, its management remains challenging due to the clinical heterogeneity and multifaceted nature of the disease. Currently available recommended algorithms for PsA treatment guide clinicians through treatment choices, beginning with conventional synthetic DMARDs after failure of non-steroidal anti-inflammatory drugs (NSAIDs) and local therapy for active disease, followed, if necessary, by a biological DMARD or a targeted synthetic (ts) DMARD. The latter novel category of DMARDs represents recent advances in the treatment options of PsA that aim to overcome the limitations of biological agents that stem by the fact that they have to be administered intravenously or subcutaneously, are very cost intensive for both the patients and the health system, while among them, the immunosuppressive biological agents are also associated with increased risks for infections and certain malignancies. The first approved tsDMARD for the treatment of PsA is apremilast which with an alternative mechanism of action, oral route of administration and favorable safety profile, presents a novel treatment option for PsA that may be appropriate for use early in the treatment algorithm.
Although there is evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, and despite the increasing recognition of the value of real-world data as a complementary source to randomized clinical trials, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice which is partially attributed to the relatively recent advent of apremilast in the market.
In light of the above, the present study primarily aims to generate real-world evidence on the impact of apremilast treatment on a broad population of biologic-naïve PsA patients in terms of its clinical effectiveness across the wide spectrum of disease manifestations, as well as its impact on disease burden and HRQoL, in the routine primary care settings of Greece. This information alongside with collected evidence regarding drug utilisation and safety profile under real-world conditions will strengthen the current state of knowledge in regards to the optimal use of apremilast in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is adult biologic-naïve PsA patients, diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy, and who have prescribed treatment with apremilast according to the routine primary care settings of Greece.
Key inclusion criteria (9 listed)
- Male or female outpatients ≥18 years of age at the time of apremilast treatment onset;
- Patients diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy;
- Patients who have been prescribed treatment with apremilast (Otezla®) for PsA, either as a monotherapy or combination therapy with classical systemic DMARD, prior to signed Informed Consent and for whom, if treatment has started, no more than one week has elapsed from treatment initiation to obtaining the signed Informed Consent;
- Patients for whom the decision to prescribe therapy with apremilast according to the locally approved SmPC has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study;
- Patients with available information on the measures needed for the calculation of cDAPSA score at the start of apremilast treatment (i.e., number of swollen and tender joints based on the 66 swollen joint count and the 68 tender joint count, respectively, and patient global assessments of disease activity and pain);
Key exclusion criteria (5 listed)
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Patients who have a history of exposure to biologic treatment and/or to tofacitinib in PsA;
- Patients that meet any of the contraindications to the administration of the apremilast as outlined in the latest version of the locally approved SmPC;
- Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the start of therapy with apremilast;
- Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the apremilast impact on peripheral PsA disease activity
Time frame: at 24 weeks post-treatment onset
Percentage of patients with active PsA treated with apremilast who will achieve at least 50% improvement in cDAPSA (clinical Disease Activity in Psoriatic Arthritis) baseline score at 24 weeks post-treatment onset
10 secondary outcomes
estimate the moderate cDAPSA response rate
Time frame: at 24 and 52 weeks post-treatment onset
estimate the major cDAPSA response rate
Time frame: at 24 and 52 weeks post-treatment onset
classify the study population into the PsA disease activity states
Time frame: at 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on enthesitis (complete resolution)
Time frame: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on enthesitis (change in LEI score)
Time frame: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on dactylitis (complete resolution)
Time frame: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on dactylitis (change from baseline)
Time frame: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on dactylitis (change in digits)
Time frame: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on patients' physical function using the HAQ-DI (change from baseline)
Time frame: at 16, 24 and 52 weeks post-treatment onset
evaluate the effect of apremilast treatment on patients' physical function using the HAQ-DI (percentage of patients)
Time frame: at 16, 24 and 52 weeks post-treatment onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Nikos Antonakopoulos, MD study director
Genesis Pharma S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Genesis Pharma S.A. at 1 site in Greece.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Results are not available in the source record.
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?
evaluate the apremilast impact on peripheral PsA disease activity (time frame: at 24 weeks post-treatment onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2021.