PsoriasisPSO-TARGETNCT04765332
Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients
An observational study of Psoriasis, run by Clinact at 27 sites in 2 countries.
Trial summary
The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- DLQI and PSO-TARGET QoL grid
- How many people
- 143 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 4 Dec 2020to 13 Mar 2023
- 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 safety population will comprise all included patients having received at least one dose of treatment. The efficacy population will comprise all included patients who fulfill all inclusion and exclusion criteria. The total number of patients included in the study, in each analysis population and related reasons of exclusion will be described. The total number of patients attended each visit, number and reasons of study discontinuation will also be described.
Who may be able to join
- Age > 18 years
- Patient for whom the dermatologist decided to initiate a treatment by Kyntheum® according to SmPC.
- Patient who signed an informed consent
Who cannot join
- Vulnerable subjects according to the law;
- pregnant, parturient or breast feeding women;
- deprived of their freedom by administrative, medical or legal decision or who is under trusteeship/guardianship;
- legally protected, or unable to express their consent to participate;
- With no affiliation to a social security system;
- Psychologically/linguistically unable to express their consent to participate
- With an hypersensitivity to at least one of the excipients of Kyntheum®
- Participating at the same time in another clinical trial
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
France17 sites
Chu de Rennes
Auray
Chru de Besancon - Hopital Jean Minjoz
Besançon
Polyclinique de Courlancy-Bezanes
Bezannes
Centre Hospitalier de Boulogne-sur-mer
Boulogne-sur-Mer
CHU de CAEN
Caen
Ch William Morey
Chalon-sur-Saône
Nouvel Hôpital Sud Francilien
Corbeil-Essonnes
Ch Annecy Genevois
Épagny
Hopital Jacques Monod
Montivilliers
Cide Azur
Nice
Ch Cote de Lumiere
Olonne-sur-Mer
Hopital Paris Saint-Joseph
Paris
Ch de Perpignan
Perpignan
CHU de Poitiers
Poitiers
Hôpital d'Instruction des armées SAINTE ANNE
Toulon
Hopital Larrey
Toulouse
CHRU de NANCY - BSM BRABOIS
Vandœuvre-lès-Nancy
Belgium10 sites
Cliniques Universitaires Saint Luc - UCLouvain
Brussels
Private practice
Geel
Private practice
Genk
Private practice
Kalken
Centre Dermatologique du Roy
Lasne
Dermatology Maldegem
Maldegem
CHU Ambroise Paré
Mons
CHU UCL Namur - Sainte Elisabeth
Namur
Private practice
Namur
Private practice
Waregem
About this study
Official title: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients
The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.
The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.
- Conditions
- Psoriasis
- Being tested
- DLQI and PSO-TARGET QoL grid
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLQI and PSO-TARGET QoL gridOther
At inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid
| Study group | Role | What they receive |
|---|---|---|
| Included patients | Fill patient questionnaires at inclusion visit, around 3 months and 12 months Receives: Other: DLQI and PSO-TARGET QoL grid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI in assessing the impact of the treatment on the patients' quality of life.
Measured: At first follow-up visit (around 12 weeks)
Secondary outcomes (15)
The percentage of patients who achieved the main treatment goal identified by the patient himself in the QoL component grid at baseline.
The therapeutic objective achievement is defined as "satisfied" or "very satisfied" response on 4 points Likert scale.
Measured: At first follow-up visit (around 12 weeks)
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI
Measured: At last follow up (around 52 weeks)
Research of predictive factors (among baseline characteristics) of the achievement of the main treatment goal.
Measured: At first follow-up visit (around 12 weeks)
Percentage of agreement between the physician-reported and the patient-reported dimensions
Measured: At first follow-up visit (around 12 weeks)
Rate of patients having changed objective at the 1st follow-up visit
Measured: At first follow-up visit (around 12 weeks)
Percentage of patients who have maintained at 52 ± 4 weeks the level of satisfaction achieved at the 1st follow-up visit.
Measured: At last follow up (around 52 weeks)
Psoriasis Area and Severity Index (PASI)
Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface
Measured: at baseline
Psoriasis Area and Severity Index (PASI)
Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface
Measured: at the 1st follow-up visit ), at the 2nd follow-up visit (52 ± 4 weeks.).
Psoriasis Area and Severity Index (PASI)
Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface
Measured: at the 2nd follow-up visit (around 52 weeks.).
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.
Measured: at baseline, at the 1st follow-up visit (12/ 16 weeks), at the 2nd follow-up visit 52 ± 4 weeks.
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.
Measured: at the 1st follow-up visit (around 12 weeks)
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.
Measured: at the 2nd follow-up visit (around 52 weeks)
Dermatology Life Quality Index (DLQI Scores)
Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)
Measured: at baseline
Dermatology Life Quality Index (DLQI Scores)
Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)
Measured: at the 1st follow-up visit (around 12 weeks)
Dermatology Life Quality Index (DLQI Scores)
Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)
Measured: at the 2nd follow-up visit (around 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start4 Dec 2020
- Primary completion10 May 2022
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinact
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Ziad Reguiai, Dr. MED, Principal investigator, POLYCLINIQUE DE COURLANCY-BEZANES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765332
- Sponsor's protocol ID
- PSO-TARGET
- Acronym
- PSO-TARGET
- Status last verified
- Aug 2023
- First submitted
- 10 Feb 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reguiai Z, Ghislain PD, Baudier E, Zraik A, Boye T. Real-World Effectiveness of Brodalumab in Challenging Psoriasis Subgroups: Insights from the PSO-TARGET Cohort. Dermatol Ther (Heidelb). 2026 Feb;16(2):1065-1088. doi: 10.1007/s13555-025-01629-2. Epub 2025 Dec 23.
PubMed 41432882Reguiai Z, Ghislain PD, Moulin P, Baudier E, Schepkens C, Sintes M, Boye T. PSO-TARGET: a New Tool to Identify the Therapeutic Expectations of Psoriasis Patients Treated with Biologics. Dermatol Ther (Heidelb). 2025 Mar;15(3):707-719. doi: 10.1007/s13555-025-01356-8. Epub 2025 Feb 21.
PubMed 39979765
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT04765332
- Acronym / sponsor ID
- PSO-TARGET / PSO-TARGET
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- ClinactUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 21 Feb 2021 (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.
The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.
The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: DLQI and PSO-TARGET QoL gridFill patient questionnaires at inclusion visit, around 3 months and 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The safety population will comprise all included patients having received at least one dose of treatment. The efficacy population will comprise all included patients who fulfill all inclusion and exclusion criteria. The total number of patients included in the study, in each analysis population and related reasons of exclusion will be described. The total number of patients attended each visit, number and reasons of study discontinuation will also be described.
Key inclusion criteria (3 listed)
- Age > 18 years
- Patient for whom the dermatologist decided to initiate a treatment by Kyntheum® according to SmPC.
- Patient who signed an informed consent
Key exclusion criteria (8 listed)
- Vulnerable subjects according to the law;
- Psychologically/linguistically unable to express their consent to participate
- With an hypersensitivity to at least one of the excipients of Kyntheum®
- Participating at the same time in another clinical trial
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 |
|---|---|---|
| DLQI and PSO-TARGET QoL gridAt inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid | Other | Included patients |
Primary outcome
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI in assessing the impact of the treatment on the patients' quality of life.
Time frame: At first follow-up visit (around 12 weeks)
15 secondary outcomes
The percentage of patients who achieved the main treatment goal identified by the patient himself in the QoL component grid at baseline.
Time frame: At first follow-up visit (around 12 weeks)
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI
Time frame: At last follow up (around 52 weeks)
Research of predictive factors (among baseline characteristics) of the achievement of the main treatment goal.
Time frame: At first follow-up visit (around 12 weeks)
Percentage of agreement between the physician-reported and the patient-reported dimensions
Time frame: At first follow-up visit (around 12 weeks)
Rate of patients having changed objective at the 1st follow-up visit
Time frame: At first follow-up visit (around 12 weeks)
Percentage of patients who have maintained at 52 ± 4 weeks the level of satisfaction achieved at the 1st follow-up visit.
Time frame: At last follow up (around 52 weeks)
Psoriasis Area and Severity Index (PASI)
Time frame: at baseline
Psoriasis Area and Severity Index (PASI)
Time frame: at the 1st follow-up visit ), at the 2nd follow-up visit (52 ± 4 weeks.).
Psoriasis Area and Severity Index (PASI)
Time frame: at the 2nd follow-up visit (around 52 weeks.).
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.
Time frame: at baseline, at the 1st follow-up visit (12/ 16 weeks), at the 2nd follow-up visit 52 ± 4 weeks.
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.
Time frame: at the 1st follow-up visit (around 12 weeks)
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.
Time frame: at the 2nd follow-up visit (around 52 weeks)
Dermatology Life Quality Index (DLQI Scores)
Time frame: at baseline
Dermatology Life Quality Index (DLQI Scores)
Time frame: at the 1st follow-up visit (around 12 weeks)
Dermatology Life Quality Index (DLQI Scores)
Time frame: at the 2nd follow-up visit (around 52 weeks)
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 Mar 2024.
- Derived from this study: PubMed 41432882Reguiai Z, Ghislain PD, Baudier E, Zraik A, Boye T. Real-World Effectiveness of Brodalumab in Challenging Psoriasis Subgroups: Insights from the PSO-TARGET Cohort. Dermatol Ther (Heidelb). 2026 Feb;16(2):1065-1088. doi: 10.1007/s13555-025-01629-2. Epub 2025 Dec 23.
- Derived from this study: PubMed 39979765Reguiai Z, Ghislain PD, Moulin P, Baudier E, Schepkens C, Sintes M, Boye T. PSO-TARGET: a New Tool to Identify the Therapeutic Expectations of Psoriasis Patients Treated with Biologics. Dermatol Ther (Heidelb). 2025 Mar;15(3):707-719. doi: 10.1007/s13555-025-01356-8. Epub 2025 Feb 21.
- 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.
Ziad Reguiai, Dr. MED principal investigator
POLYCLINIQUE DE COURLANCY-BEZANES
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Clinact at 27 sites in 2 countries.
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 3 inclusion and 8 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Belgium. 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?
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI in assessing the impact of the treatment on the patients' quality of life. (time frame: At first follow-up visit (around 12 weeks)). 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 NCT04765332, which also lists 2 linked publications.
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 Mar 2024.