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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Participants will receive risankizumab as prescribed by their physician according to local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Current or recent (within the last 30 days) participation in an interventional clinical trial.
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Adult moderate to severe Psoriasis participants treated with labeled dose of Risankizumab.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite Libre de Bruxelles - Hopital Erasme /ID# 252456 | Anderlecht | Brussels Capital | 1070 | Belgium | ||
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| Cliniques Universitaires UCL Saint-Luc /ID# 253234 |
| Brussels |
| Brussels Capital |
| 1200 |
| Belgium |
| UZ Gent /ID# 252458 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Dermatologie Maldegem /ID# 252454 | Maldegem | Oost-Vlaanderen | 9990 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 252457 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Wiseman Dermatology Research /ID# 255883 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Dermatrials Research /ID# 253879 | Hamilton | Ontario | L8N 1Y2 | Canada |
| Lynde Institute for Dermatology /ID# 253876 | Markham | Ontario | L3P 1X2 | Canada |
| JRB Research /ID# 253877 | Ottawa | Ontario | K1H 7X3 | Canada |
| SKiN Centre for Dermatology /ID# 255882 | Peterborough | Ontario | K9J 5K2 | Canada |
| Dre Angelique Gagne-Henley M.D. inc. /ID# 262591 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Hautarztpraxis Mortazawi /ID# 255872 | Remscheid | North Rhine-Westphalia | 42897 | Germany |
| Dermatologische Praxis Dr. med. Marvin Kuske /ID# 265688 | Dresden | 01109 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf /ID# 254340 | Hamburg | 20246 | Germany |
| Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 255874 | Heilbad Heiligenstadt | 37308 | Germany |
| Praxis Dres. Wiemers/Wiemers /ID# 255873 | Leipzig | 04317 | Germany |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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