Clinical trial 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Plaque Psoriasis
PsO
Psoriasis
Risankizumab
RZB
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult moderate to severe Psoriasis participants treated with labeled dose of Risankizumab.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Validity of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
timeFrame: Baseline through Week 28
measure: Reliability of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
timeFrame: Baseline through Week 28
measure: Responsiveness of the Cumulative Life Course Impairment Instrument (DermCLCI-p)
timeFrame: Baseline through Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 252456
state: Bruxelles-Capitale
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 253234
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 252458
state: Oost-Vlaanderen
city: Maldegem
country: Belgium
facility: Dermatologie Maldegem /ID# 252454
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 252457
state: Vlaams-Brabant
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 255883
state: Manitoba
city: Hamilton
country: Canada
facility: Dermatrials Research /ID# 253879
state: Ontario
city: Markham
country: Canada
facility: Lynde Institute for Dermatology /ID# 253876
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research /ID# 253877
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology /ID# 255882
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 262591
state: Quebec
city: Remscheid
country: Germany
facility: Hautarztpraxis Mortazawi /ID# 255872
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Dermatologische Praxis Dr. med. Marvin Kuske /ID# 265688
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 254340
city: Heilbad Heiligenstadt
country: Germany
facility: Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 255874
city: Leipzig
country: Germany
facility: Praxis Dres. Wiemers/Wiemers /ID# 255873
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: