Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis

Официальное название

The Real-World Impact of Risankizumab on the Quality of Life and Cumulative Life Course Impairment (CLCI) in Patients With Moderate-to-Severe Plaque Psoriasis (DREAM)

Обзор

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice. Risankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Первичные конечные точки

• Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 [Срок оценки: At 12 months]

Критерии участия

Критерии включения

• Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.
• Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing/treatment guidelines.
• Decision to treat with risankizumab is made prior to and independently of study participation.

Критерии исключения

• History of a sleep disorder diagnosis which the patient is currently being treated for.
• Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.
• Currently receiving other biologic treatments and/or small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Япония · 19 центров

• Gunma University Hospital /ID# 278497 — Maebashi
• Asahikawa Medical University Hospital /ID# 278981 — Asahikawa-shi
• Hokkaido University Hospital /ID# 278260 — Sapporo
• Hosui General Medical Clinic /ID# 279520 — Sapporo
• Kagoshima University Hospital /ID# 278514 — Kagoshima
• Tokai University Hospital /ID# 278294 — Isehara
• Yokohama City University Hospital /ID# 278257 — Yokohama
• University Hospital Kyoto Prefectural University of Medicine /ID# 278962 — Kyoto
• … и ещё 11 центров

Канада · 18 центров

• Dermatology Research Institute - Blackfoot Trail /ID# 276722 — Calgary
• Rejuvenation Dermatology - Edmonton Downtown /ID# 276688 — Edmonton
• Winnipeg Clinic /ID# 276751 — Winnipeg
• Wiseman Dermatology Research /ID# 276847 — Winnipeg
• Cca Medical Research /ID# 276944 — Ajax
• Quinte dermatology /ID# 277497 — Belleville
• Dermatrials Research /ID# 276714 — Hamilton
• Lovegrove Dermatology /ID# 276797 — London
• … и ещё 10 центров

Германия · 11 центров

• Dr. med. Moritz Huber und Dr. med. Martin Heister /ID# 277627 — Friedrichshafen
• Dermakulm /Id# 277864 — Kulmbach
• Dermazent /Id# 280327 — Munich
• Hautaerzte am Nauener Tor /ID# 284579 — Potsdam
• Universitaetsmedizin Mainz /ID# 278229 — Mainz
• Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 277628 — Mölln
• Universitaetsklinikum Hamburg-Eppendorf /ID# 277164 — Hamburg
• Cutaneum /ID# 277294 — Hamburg
• … и ещё 3 центра

Греция · 9 центров

• General Hospital Andreas Syggros /ID# 276826 — Athens
• General Hospital Andreas Syggros /ID# 279246 — Athens
• University General Hospital Attikon /ID# 278389 — Chaïdári
• Tzaneio Prefecture General Hospital of Piraeus /ID# 276532 — Piraeus
• Asklipieio General Hospital of Voula /ID# 278235 — Voula
• The University Hospital of Larissa /ID# 276576 — Larissa
• Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 276488 — Thessaloniki
• Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 276489 — Thessaloniki
• … и ещё 1 центр

Испания · 7 центров

• Hospital Regional Universitario de Malaga /ID# 277220 — Málaga
• Hospital Universitario de Leon /ID# 277895 — León
• Hospital General Universitario Santa Maria Del Rosell /ID# 277894 — Cartagena
• Hospital Clinico Universitario Virgen de la Arrixaca /ID# 283338 — El Palmar
• Hospital General Universitario Morales Meseguer /ID# 283339 — Murcia
• Complejo Hospitalario Universitario de Pontevedra /ID# 278085 — Pontevedra
• … и ещё 1 центр

Чехия · 6 центров

• Fakultni Nemocnice U Sv. Anny V Brne /ID# 275799 — Brno
• Fakultni nemocnice Bulovka /ID# 275540 — Prague
• Dermafit Centrum /ID# 275897 — Pilsen
• Dermamedest /ID# 275898 — Prague
• Nemocnice Ceske Budejovice /ID# 275541 — České Budějovice
• Fakultni nemocnice Kralovske Vinohrady /ID# 275800 — Prague

Франция · 6 центров

• Chu de Dijon /ID# 279900 — Dijon
• Centre Hospitalier de Niort Georges Renon /ID# 279604 — Niort
• Hopitaux Drome Nord - Romans /ID# 278109 — Romans-sur-Isère
• Dr. Rima Mohty /ID# 279951 — Beauvais
• Centre Hospitalier Du Mans /ID# 279899 — Le Mans
• Hopital d'Instruction des Armees Sainte-Anne /ID# 278106 — Toulon

Италия · 5 центров

• ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 277341 — L’Aquila
• IRCCS Ospedale San Raffaele /ID# 277342 — Milan
• Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 277713 — Naples
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 2780 — Rome
• Ospedale San Martino /ID# 278984 — Genova

Идентификаторы

NCT: NCT07039110 · P25-187

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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