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

Status: Recruiting
Location: See all (22) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with a confirmed diagnosis of moderate plaque PsO made by a specialist ≤24 months prior to risankizumab prescription defined as:

‣ Percentage of body surface affected by PsO Body Surface Area (BSA) \>2% and \<20%

⁃ Psoriasis Area and Severity Index (PASI) score \>10

⁃ Static Physician's Global Assessment (sPGA) score =3 (moderate) based on a 5-point scale (0-4)

• Participants naïve to advanced treatments (biologics, apremilast, and deucravacitinib)

• Participants who have been prescribed treatment with risankizumab in line with marketing authorization and local access conditions, prior to signed Informed Consent

• Decision to treat with risankizumab has been made independently and prior to enrolment in the study

• Participants must be willing and able to read and complete the study specific questionnaires

Locations
Other Locations
Greece
West Attica General Hospital Agia Varvara /ID# 266256
RECRUITING
Agía Varvára
251 Hellenic Air Force General Hospital /ID# 268135
RECRUITING
Athens
401 General Military Hospital /ID# 277393
RECRUITING
Athens
General Hospital Andreas Syggros /ID# 263443
RECRUITING
Athens
General Hospital Andreas Syggros /ID# 266248
RECRUITING
Athens
Hygeia Hospital /ID# 263455
RECRUITING
Athens
Iatriko Psichikou /ID# 272851
RECRUITING
Athens
University General Hospital Attikon /ID# 263442
RECRUITING
Athens
University General Hospital of Heraklion /ID# 268777
RECRUITING
Heraklion
Venizelio Regional General Hospital of Heraklion /ID# 268778
RECRUITING
Heraklion
KAT Attica General Hospital /ID# 266249
RECRUITING
Kifissia
University General Hospital of Larissa /ID# 263440
RECRUITING
Larissa
Konstantopoulio General Hospital /ID# 266257
RECRUITING
Nea Ionia
Olympion General Clinic /ID# 266258
RECRUITING
Pátrai
Tzaneio Prefecture General Hospital of Piraeus /ID# 263448
RECRUITING
Piraeus
General Hospital of Thessaloniki Agios Pavlos'' /ID# 267506
RECRUITING
Thessaloniki
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530
RECRUITING
Thessaloniki
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452
RECRUITING
Thessaloniki
Papageorgiou General Hospital /ID# 262529
RECRUITING
Thessaloniki
General Hospital of Tripoli Panarkadiko Evangelistria /ID# 266251
RECRUITING
Tripoli
Asklipieio General Hospital of Voula /ID# 268136
RECRUITING
Voula
General Hospital of Xanthi /ID# 268133
RECRUITING
Xánthi
Contact Information
Primary
Katerina Kollia
katerina.kollia@abbvie.com
+302 1441 654 75
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2027-10
Participants
Target number of participants: 250
Treatments
Participants Treated with Risankizumab
Participants with a recent diagnosis of moderate plaque PsO (defined as ≤24 months since the first diagnosis of moderate PsO), and naïve to advanced treatments (biologics, apremilast, and deucravacitinib) will receive risankizumab as prescribed by their physician according to local label.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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