Multi-Country Prospective Real-World Study to Validate the CLCI Instrument (DermCLCI-p) in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (IMMagine)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 154
- Locations
- 16
- Primary Endpoint
- Reliability of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Reliability of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
Time Frame: Baseline through Week 28
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).
Validity of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
Time Frame: Baseline through Week 28
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).
Responsiveness of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
Time Frame: Baseline through Week 28
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).
Secondary Outcomes
No secondary outcomes reported