Moderate Plaque PsoriasisAPRAISALNCT03059953
A Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)
An observational study of Moderate Plaque Psoriasis, run by Genesis Pharma S.A. at 1 site in Greece.
Trial summary
For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompasses treatment with biologic agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Plaque Psoriasis
- How many people
- 302 participants
- Where
- 1 siteGreece
- Study dates
- 7 Apr 2017to 24 Apr 2019
- 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: Male and female patients ≥ 18 years of age, diagnosed with moderate chronic plaque psoriasis [(10<BSA<20 or 10<PASI<20) and 10<DLQI<20], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy and naïve to biologic treatments
Who may be able to join
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Male and female patients ≥ 18 years of age at the time of informed consent;
- Patients diagnosed with moderate chronic plaque psoriasis [(10<BSA<20 or 10<PASI<20) and 10<DLQI<20], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy;
- Patients naïve to biologic treatments;
- Patients for whom the decision to prescribe therapy with apremilast (Otezla®) according to the locally approved summary of product characteristics (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 BSA, PASI and DLQI scores at the start of apremilast treatment;
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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 adhere to the study visit schedule and other protocol requirements.
Who cannot join
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Patients who have initiated treatment with apremilast more than 7 days before enrollment into the study;
- 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 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 commencement 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 of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)
For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompasses treatment with biologic agents. The direct and indirect costs of biologic treatment, accruing, among others, from the high drug acquisition and administration costs, the required baseline safety screening and subsequent routine monitoring as well as the potential loss of patients' working hours constitute a significant financial burden on the public healthcare system. In light of the above evidence, it appears that in routine care apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by providing a promising treatment option to be employed prior to biologics, which has demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles, and has a limited manageable safety profile, while being more convenient and cost-effective than biologics.
In view of the scarcity of real-world evidence regarding the impact of apremilast on the patients' health-related quality of life (HRQoL) and extent and severity of the disease, and under the consideration that the moderate psoriasis patient {defined as [10<body surface area (BSA)<20 or 10<psoriasis area severity index (PASI)<20] and 10<dermatology quality of life index (DLQI)<20}, naïve to biologic treatment was likely underrepresented in the pivotal ESTEEM trials since approximately 30% of the enrolled patients had been previously treated with biologic therapy, 28-30% had a baseline PASI score >20, and 48-52% had a BSA >20%, this study represents an attempt to examine the impact of apremilast in routine clinical practice settings in Greece on the patient with moderate plaque psoriasis when this therapeutic strategy precedes biologics in the treatment algorithm.
Specifically, the present study aims to generate novel real-world evidence on the effect of apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate, and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus, while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the routine clinical practice of Greece.
- Conditions
- Moderate Plaque Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)
Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)
Measured: at 24 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 posted23 Feb 2017
- Study start7 Apr 2017
- Primary completion6 Apr 2018
- Study completion24 Apr 2019
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 Moderate Plaque PsoriasisStudies 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Pharma S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059953
- Sponsor's protocol ID
- GEN-NIS-APR-001
- Acronym
- APRAISAL
- Status last verified
- May 2021
- First submitted
- 17 Feb 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ioannides D, Antonakopoulos N, Georgiou S, Chasapi V, Katsantonis I, Drosos A, Rigopoulos D, Antoniou C, Anastasiadis G, Bassukas I, Ioannidou D, Protopapa A, Neofotistou O, Krasagakis K, Aronis P, Papageorgiou M, Lazaridou E, Patsatsi A, Lefaki I, Roussaki-Schulze AV, Satra F, Anagnostopoulos Z, Papakonstantis M. Effectiveness and safety of apremilast in biologic-naive patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study. J Eur Acad Dermatol Venereol. 2021 Sep;35(9):1838-1848. doi: 10.1111/jdv.17392. Epub 2021 Jul 13.
PubMed 34036627
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective, Observational Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)
- ClinicalTrials.gov ID
- NCT03059953
- Acronym / sponsor ID
- APRAISAL / GEN-NIS-APR-001
- Conditions
- Moderate Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Genesis Pharma S.A.Industry (pharma, biotech, devices)
- Collaborators
- Celgene
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 23 Feb 2017 (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.
For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompasses treatment with biologic agents. The direct and indirect costs of biologic treatment, accruing, among others, from the high drug acquisition and administration costs, the required baseline safety screening and subsequent routine monitoring as well as the potential loss of patients' working hours constitute a significant financial burden on the public healthcare system. In light of the above evidence, it appears that in routine care apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by providing a promising treatment option to be employed prior to biologics, which has demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles, and has a limited manageable safety profile, while being more convenient and cost-effective than biologics.
In view of the scarcity of real-world evidence regarding the impact of apremilast on the patients' health-related quality of life (HRQoL) and extent and severity of the disease, and under the consideration that the moderate psoriasis patient {defined as [10<body surface area (BSA)<20 or 10<psoriasis area severity index (PASI)<20] and 10<dermatology quality of life index (DLQI)<20}, naïve to biologic treatment was likely underrepresented in the pivotal ESTEEM trials since approximately 30% of the enrolled patients had been previously treated with biologic therapy, 28-30% had a baseline PASI score >20, and 48-52% had a BSA >20%, this study represents an attempt to examine the impact of apremilast in routine clinical practice settings in Greece on the patient with moderate plaque psoriasis when this therapeutic strategy precedes biologics in the treatment algorithm.
Specifically, the present study aims to generate novel real-world evidence on the effect of apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate, and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus, while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the routine clinical practice of Greece.
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
- Male and female patients ≥ 18 years of age, diagnosed with moderate chronic plaque psoriasis [(10<BSA<20 or 10<PASI<20) and 10<DLQI<20], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy and naïve to biologic treatments
Key inclusion criteria (9 listed)
- Male and female patients ≥ 18 years of age at the time of informed consent;
- Patients diagnosed with moderate chronic plaque psoriasis [(10<BSA<20 or 10<PASI<20) and 10<DLQI<20], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy;
- Patients naïve to biologic treatments;
- Patients for whom the decision to prescribe therapy with apremilast (Otezla®) according to the locally approved summary of product characteristics (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 BSA, PASI and DLQI scores at the start of apremilast treatment;
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 initiated treatment with apremilast more than 7 days before enrollment into the study;
- 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 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 commencement 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
Quality of Life - Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)
Time frame: at 24 weeks post-treatment onset
Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)
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 19 Aug 2021.
- Results publication: PubMed 34036627Ioannides D, Antonakopoulos N, Georgiou S, Chasapi V, Katsantonis I, Drosos A, Rigopoulos D, Antoniou C, Anastasiadis G, Bassukas I, Ioannidou D, Protopapa A, Neofotistou O, Krasagakis K, Aronis P, Papageorgiou M, Lazaridou E, Patsatsi A, Lefaki I, Roussaki-Schulze AV, Satra F, Anagnostopoulos Z, Papakonstantis M. Effectiveness and safety of apremilast in biologic-naive patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study. J Eur Acad Dermatol Venereol. 2021 Sep;35(9):1838-1848. doi: 10.1111/jdv.17392. Epub 2021 Jul 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Moderate Plaque Psoriasis, 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: finished, as of the sponsor's last update on 19 Aug 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?
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?
Quality of Life - Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL) (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?
On the ClinicalTrials.gov record for NCT03059953, 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 19 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.