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Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece
Sponsor: AbbVie
Summary
Psoriasis is a skin disorder wherein skin cells multiply faster than normal, making the skin itchy and look patchy and red. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. The impact of Psoriasis on quality of life can be significant, especially in moderate-to-severe disease which affects approximately half of the participants with plaque Psoriasis. Participants with Psoriasis are marked by their disease physically, psychologically, and emotionally. In addition to the above, their disease exerts a negative effect on various dimensions of health-related quality of life such as daily activities and work productivity. This study is designed to provide information regarding the impact of risankizumab on short-term and long-term clinical parameters of Psoriasis as well as the patient-reported outcomes (PROs) in participants with a recent diagnosis (less than or equal to 24 months) of moderate Psoriasis who are naïve to advanced treatments. Risankizumab is an approved drug for the treatment of Plaque Psoriasis. Approximately 250 participants with a recent diagnosis of moderate plaque psoriasis (defined as less than or equal to 24 months since the first diagnosis of moderate Psoriasis), and naïve to advanced treatments (biologics, apremilast, and deucravacitinib) will be enrolled at approximately 20 sites in Greece. Participants will receive risankizumab as prescribed by their treating dermatologist in accordance with local authorization and independently from the study. Participants will be enrolled and observed for approximately two years. There is expected to be no additional burden for participants in this trial. Study visits comprised of private practices and hospital clinics as per standard of care.
Official title: A Non-interventional, Prospective Study to Evaluate the Effectiveness of Risankizumab in Patients With Recent Diagnosis of Moderate Plaque Psoriasis in a Real Life Setting in Greece- the REDEFINE Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-04-29
Completion Date
2027-10
Last Updated
2026-02-04
Healthy Volunteers
No
Locations (22)
Olympion General Clinic /ID# 266258
Pátrai, Achaia, Greece
Iatriko Psichikou /ID# 272851
Athens, Attica, Greece
251 Hellenic Air Force General Hospital /ID# 268135
Athens, Attica, Greece
University General Hospital Attikon /ID# 263442
Athens, Attica, Greece
General Hospital Andreas Syggros /ID# 263443
Athens, Attica, Greece
General Hospital Andreas Syggros /ID# 266248
Athens, Attica, Greece
Tzaneio Prefecture General Hospital of Piraeus /ID# 263448
Piraeus, Attica, Greece
Asklipieio General Hospital of Voula /ID# 268136
Voula, Attica, Greece
University General Hospital of Heraklion /ID# 268777
Heraklion, Crete, Greece
Venizelio Regional General Hospital of Heraklion /ID# 268778
Heraklion, Irakleio, Greece
Konstantopoulio General Hospital /ID# 266257
Nea Ionia, Magnisia, Greece
West Attica General Hospital "Agia Varvara" /ID# 266256
Agía Varvára, Greece
401 General Military Hospital /ID# 277393
Athens, Greece
Hygeia Hospital /ID# 263455
Athens, Greece
KAT Attica General Hospital /ID# 266249
Kifissia, Greece
University General Hospital of Larissa /ID# 263440
Larissa, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530
Thessaloniki, Greece
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452
Thessaloniki, Greece
General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506
Thessaloniki, Greece
Papageorgiou General Hospital /ID# 262529
Thessaloniki, Greece
General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251
Tripoli, Greece
General Hospital of Xanthi /ID# 268133
Xánthi, Greece