Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients

Study Purpose

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®.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04765332
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Clinact
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ziad Reguiai, Dr. MED
Principal Investigator Affiliation POLYCLINIQUE DE COURLANCY-BEZANES
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries Belgium, France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

: Included patients

Fill patient questionnaires at inclusion visit, around 3 months and 12 months

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bruxelles, Belgium

Status

Not yet recruiting

Address

Cliniques Universitaires Saint Luc - UCLouvain

Bruxelles, ,

Site Contact

Pierre-dominique GHISLAIN

[email protected]

+33180131470

Private practice, Geel, Belgium

Status

Not yet recruiting

Address

Private practice

Geel, ,

Site Contact

Hugo BOONEN

[email protected]

+33180131470

Private practice, Genk, Belgium

Status

Not yet recruiting

Address

Private practice

Genk, ,

Site Contact

Karen VERMEERSCH

[email protected]

+33180131470

Private practice, Kalken, Belgium

Status

Not yet recruiting

Address

Private practice

Kalken, ,

Site Contact

DIERICK

[email protected]

+33180131470

Centre Dermatologique du Roy, Lasne, Belgium

Status

Not yet recruiting

Address

Centre Dermatologique du Roy

Lasne, ,

Site Contact

Muriel CREUSOT

[email protected]

+33180131470

Dermatology Maldegem, Maldegem, Belgium

Status

Not yet recruiting

Address

Dermatology Maldegem

Maldegem, ,

Site Contact

Sven LANSENS

[email protected]

+33180131470

CHU Ambroise Paré, Mons, Belgium

Status

Not yet recruiting

Address

CHU Ambroise Paré

Mons, ,

Site Contact

Evelyne BERLINGIN

[email protected]

+33180131470

CHU UCL Namur - Sainte Elisabeth, Namur, Belgium

Status

Not yet recruiting

Address

CHU UCL Namur - Sainte Elisabeth

Namur, ,

Site Contact

Olivier VANHOOTEGHEM

[email protected]

+33180131470

Private practice, Namur, Belgium

Status

Not yet recruiting

Address

Private practice

Namur, ,

Site Contact

Bernadette BLOUARD

[email protected]

+33180131470

Private practice, Waregem, Belgium

Status

Not yet recruiting

Address

Private practice

Waregem, ,

Site Contact

Martine BOURGEOIS

[email protected]

+33180131470

Chu de Rennes, Auray, France

Status

Recruiting

Address

Chu de Rennes

Auray, ,

Site Contact

Marc PERRUSSEL

[email protected]

+33180131470

Chru de Besancon - Hopital Jean Minjoz, Besançon, France

Status

Not yet recruiting

Address

Chru de Besancon - Hopital Jean Minjoz

Besançon, ,

Site Contact

François AUBIN, MD

[email protected]

+33180131470

Polyclinique de Courlancy-Bezanes, Bezannes, France

Status

Recruiting

Address

Polyclinique de Courlancy-Bezanes

Bezannes, ,

Site Contact

Ziad REGUIAI

[email protected]

+33180131470

Centre Hospitalier de Boulogne-sur-mer, Boulogne-sur-Mer, France

Status

Recruiting

Address

Centre Hospitalier de Boulogne-sur-mer

Boulogne-sur-Mer, ,

Site Contact

Sophie DARRAS

[email protected]

+33180131470

CHU de CAEN, Caen, France

Status

Not yet recruiting

Address

CHU de CAEN

Caen, ,

Site Contact

Cécile CLEMENT-LEPLEY

[email protected]

+33180131470

Ch William Morey, Chalon-sur-Saône, France

Status

Recruiting

Address

Ch William Morey

Chalon-sur-Saône, ,

Site Contact

Marie DHERS

[email protected]

+33180131470

Nouvel Hôpital Sud Francilien, Corbeil-Essonnes, France

Status

Not yet recruiting

Address

Nouvel Hôpital Sud Francilien

Corbeil-Essonnes, ,

Site Contact

Mostefa RAFAA

[email protected]

+33180131470

Hopital Jacques Monod, Montivilliers, France

Status

Not yet recruiting

Address

Hopital Jacques Monod

Montivilliers, ,

Site Contact

Claire BOULARD, MD

[email protected]

+33180131470

Cide Azur, Nice, France

Status

Not yet recruiting

Address

Cide Azur

Nice, ,

Site Contact

Abdallah KHEMIS

[email protected]

+33180131470

Ch Cote de Lumiere, Olonne-sur-Mer, France

Status

Recruiting

Address

Ch Cote de Lumiere

Olonne-sur-Mer, ,

Site Contact

Marie LECOUFLET

[email protected]

+33180131470

Hopital Paris Saint-Joseph, Paris, France

Status

Recruiting

Address

Hopital Paris Saint-Joseph

Paris, ,

Site Contact

Dominique LONS-DANIC

[email protected]

+33180131470

Ch de Perpignan, Perpignan, France

Status

Not yet recruiting

Address

Ch de Perpignan

Perpignan, ,

Site Contact

Valérie PALLURE

[email protected]

+33180131470

CHU de Poitiers, Poitiers, France

Status

Not yet recruiting

Address

CHU de Poitiers

Poitiers, ,

Site Contact

Ewa WIERZBICKA-HAINAUT

[email protected]

+33180131470

Toulon, France

Status

Recruiting

Address

Hôpital d'Instruction des armées SAINTE ANNE

Toulon, ,

Site Contact

Thierry BOYE

[email protected]

+33180131470

Hopital Larrey, Toulouse, France

Status

Not yet recruiting

Address

Hopital Larrey

Toulouse, ,

Site Contact

Cristina BULAI LIVIDEANU

[email protected]

+33180131470

CHRU de NANCY - BSM BRABOIS, Vandœuvre-lès-Nancy, France

Status

Not yet recruiting

Address

CHRU de NANCY - BSM BRABOIS

Vandœuvre-lès-Nancy, ,

Site Contact

Julie HENRY

[email protected]

+33180131470

Ch Annecy Genevois, Épagny, France

Status

Not yet recruiting

Address

Ch Annecy Genevois

Épagny, ,

Site Contact

Matthieu LEVAVASSEUR

[email protected]

+33180131470

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