An observational study in Psoriatic Arthritis, sponsored by Genesis Pharma S.A.. Status unknown at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Genesis Pharma S.A. · Observational
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 170 is close to the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Genesis Pharma S.A. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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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.
Patients eligible for inclusion in this study have to meet all of the following criteria:
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from participation in this study:
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
Time frame: at 24 weeks post-treatment onset
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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
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)
Change from baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) score among the overall study population.
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)
Percentage of patients with HAQ-DI response among the overall study population )(HAQ-DI score: 0-3)
Time frame: at 16, 24 and 52 weeks post-treatment onset
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Genesis Pharma S.A.