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NCT06247319

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

View on ClinicalTrials.gov

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