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Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients (PSO-TARGET)

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ClinicalTrials.gov Identifier: NCT04765332
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Clinact

Brief 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 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®.


Condition or disease Intervention/treatment
Psoriasis Other: DLQI and PSO-TARGET QoL grid

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients
Actual Study Start Date : December 4, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
Included patients
Fill patient questionnaires at inclusion visit, around 3 months and 12 months
Other: DLQI and PSO-TARGET QoL grid
At inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
    The therapeutic objective achievement is defined as "satisfied" or "very satisfied" response on 4 points Likert scale.

  2. 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) ]
  3. 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) ]
  4. Percentage of agreement between the physician-reported and the patient-reported dimensions [ Time Frame: At first follow-up visit (around 12 weeks) ]
  5. Rate of patients having changed objective at the 1st follow-up visit [ Time Frame: At first follow-up visit (around 12 weeks) ]
  6. 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) ]
  7. Psoriasis Area and Severity Index (PASI) [ Time Frame: at baseline ]
    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

  8. Psoriasis Area and Severity Index (PASI) [ Time Frame: at the 1st follow-up visit ), at the 2nd follow-up visit (52 ± 4 weeks.). ]
    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

  9. Psoriasis Area and Severity Index (PASI) [ Time Frame: at the 2nd follow-up visit (around 52 weeks.). ]
    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

  10. 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. ]
  11. 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) ]
  12. 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) ]
  13. Dermatology Life Quality Index (DLQI Scores) [ Time Frame: at baseline ]
    Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)

  14. Dermatology Life Quality Index (DLQI Scores) [ Time Frame: at the 1st follow-up visit (around 12 weeks) ]
    Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)

  15. Dermatology Life Quality Index (DLQI Scores) [ Time Frame: at the 2nd follow-up visit (around 52 weeks) ]
    Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patient for whom the dermatologist decided to initiate a treatment by Kyntheum® according to SmPC.
  • Patient who signed an informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765332


Contacts
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Contact: Kelly Tiercelet +33180131470 kelly.tiercelet@clinact.com
Contact: Léa Talbot +33180131470 lea.talbot@clinact.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
Clinact
LEO Pharma
Investigators
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Principal Investigator: Ziad Reguiai, Dr. MED POLYCLINIQUE DE COURLANCY-BEZANES
  Study Documents (Full-Text)

Documents provided by Clinact:
Study Protocol  [PDF] May 25, 2020

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Responsible Party: Clinact
ClinicalTrials.gov Identifier: NCT04765332    
Other Study ID Numbers: PSO-TARGET
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases