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)

Psoriasis Clinical Trial

— IMMagine  

Official title:

Multi-Country Prospective Real-World Study to Validate the CLCI Instrument (DermCLCI-p) in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (IMMagine)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959070
• Other study ID #: P23-435
• Status: Recruiting
• Start date: November 9, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: Simone Rubant
• Phone: +49 611-1720-1241
• Email: simone.rubant[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Belgium	Université Libre de Bruxelles - Hôpital Erasme /ID# 252456	Anderlecht	Bruxelles-Capitale
Belgium	UZ Gent /ID# 252458	Gent	Oost-Vlaanderen
Belgium	Universitair Ziekenhuis Leuven /ID# 252457	Leuven	Vlaams-Brabant
Belgium	Dermatologie Maldegem /ID# 252454	Maldegem	Oost-Vlaanderen
Belgium	UCL Saint-Luc /ID# 253234	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	Dermatrials Research /ID# 253879	Hamilton	Ontario
Canada	Lynderm Research Inc. /ID# 253876	Markham	Ontario
Canada	JRB Research /ID# 253877	Ottawa	Ontario
Canada	SKiN Centre for Dermatology /ID# 255882	Peterborough	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 262591	Saint-Jerome	Quebec
Canada	Wiseman Dermatology Research /ID# 255883	Winnipeg	Manitoba
Germany	Dermatologische Praxis Dr. med. Marvin Kuske /ID# 265688	Dresden
Germany	Universitaetsklinikum Hamburg-Eppendorf /ID# 254340	Hamburg
Germany	Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 255874	Heilbad Heiligenstadt
Germany	Praxis Dres. Wiemers/Wiemers /ID# 255873	Leipzig
Germany	Hautarztpraxis Mortazawi /ID# 255872	Remscheid	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Belgium,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline through Week 28
Primary	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).	Baseline through Week 28
Primary	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).	Baseline through Week 28

External Links

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