NCT05959070 - An Observational Study to Validate the Cumulative Life Course Impairment (CLCI) Instrument (DermCLCI-p) in Adult Participants With Moderate to Severe Chronic Plaque Psoriasis (PsO) | Crick

Overview

The IMMagine study aims to validate the newly developed CLCI instrument (DermCLCI-p) in moderate to severe psoriasis (PsO) patients, who will be started on Risankizumb (RZB) treatment and will be enrolled into the validation study up to 28 weeks. The treatment decision for RZB must be made independent of this study enrollment.

Study Type

OBSERVATIONAL

Enrollment

154

Conditions

Psoriasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a dermatologist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment. * Participants initiating RZB treatment for psoriasis as per local label. Physician's decision for treatment with risankizumab must have been reached prior to and independently of recruitment in the study. * Participants able to understand and communicate with the investigator and comply with the requirements of the study. * Willingness and ability to comply with all study requirements. Exclusion Criteria: \- Current or recent (within the last 30 days) participation in an interventional clinical trial.

Locations (16)

Universite Libre de Bruxelles - Hopital Erasme /ID# 252456

Anderlecht, Brussels Capital, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 253234

Brussels, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Validity of the Cumulative Life Course Impairment Instrument (DermCLCI-p)

The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).

Time frame: Baseline through Week 28

Reliability of the Cumulative Life Course Impairment Instrument (DermCLCI-p)

The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).

Time frame: Baseline through Week 28

Responsiveness of the Cumulative Life Course Impairment Instrument (DermCLCI-p)

The DermCLCI-p Questionnaire assesses the cumulative impairments in skin diseases. The DermCLCI instrument consists of 30 items and asks participants to consider their disease burden within the last two weeks. Items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).

Time frame: Baseline through Week 28