Evaluating the effectiveness of risankizumab for moderate plaque psoriasis in Greece
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
This study is testing how well risankizumab works for people in Greece with moderate plaque psoriasis who haven't tried advanced treatments yet, to see how it affects their skin and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | risankizumab, deucravacitinib |
| Locations | 21 sites (Patras, Achaia and 20 other locations) |
| Trial ID | NCT06247319 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of risankizumab in patients diagnosed with moderate plaque psoriasis within the last 24 months. It focuses on evaluating both clinical parameters and patient-reported outcomes to understand the treatment's impact on quality of life. Participants must be naïve to advanced treatments and have specific severity scores for their psoriasis. The study will gather data in a real-life setting across multiple locations in Greece.
Who should consider this trial
Good fit: Ideal candidates are individuals with a recent diagnosis of moderate plaque psoriasis who have not previously received advanced treatments.
Not a fit: Patients currently undergoing treatment with investigational drugs or those with severe psoriasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of risankizumab, potentially improving treatment options for patients with moderate plaque psoriasis.
How similar studies have performed: Other studies evaluating biologic treatments for psoriasis have shown promising results, indicating that this approach is supported by prior successful research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Participants who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days before risankizumab initiation * Pregnancy or lactation * Unwilling or unable to provide informed consent
Where this trial is running
Patras, Achaia and 20 other locations
- Olympion General Clinic /ID# 266258 — Patras, Achaia, Greece (Recruiting)
- Iatriko Psichikou /ID# 272851 — Athens, Attiki, Greece (Recruiting)
- 251 Hellenic Air Force General Hospital /ID# 268135 — Athens, Attiki, Greece (Recruiting)
- University General Hospital Attikon /ID# 263442 — Athens, Attiki, Greece (Recruiting)
- General Hospital Andreas Syggros /ID# 263443 — Athens, Attiki, Greece (Recruiting)
- General Hospital Andreas Syggros /ID# 266248 — Athens, Attiki, Greece (Recruiting)
- Tzaneio Prefecture General Hospital of Piraeus /ID# 263448 — Pireas, Attiki, Greece (Recruiting)
- Asklipieio General Hospital of Voula /ID# 268136 — Voula, Attiki, Greece (Recruiting)
- Venizelio Regional General Hospital of Heraklion /ID# 268778 — Iraklio, Irakleio, Greece (Recruiting)
- Konstantopoulio General Hospital /ID# 266257 — Nea Ionia, Magnisia, Greece (Recruiting)
- West Attica General Hospital "Agia Varvara" /ID# 266256 — Agia Varvara, Greece (Recruiting)
- Hygeia Hospital /ID# 263455 — Athens, Greece (Recruiting)
- University General Hospital of Heraklion /ID# 268777 — Heraklion, Greece (Recruiting)
- KAT Attica General Hospital /ID# 266249 — Kifissia, Greece (Recruiting)
- University General Hospital of Larissa /ID# 263440 — Larissa, Greece (Recruiting)
- Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530 — Thessaloniki, Greece (Recruiting)
- Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452 — Thessaloniki, Greece (Recruiting)
- General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506 — Thessaloniki, Greece (Recruiting)
- Papageorgiou General Hospital /ID# 262529 — Thessaloniki, Greece (Recruiting)
- General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251 — Tripoli, Greece (Recruiting)
- General Hospital of Xanthi /ID# 268133 — Xanthi, Greece (Recruiting)
Study contacts
- Study coordinator: Katerina Kollia
- Email: katerina.kollia@abbvie.com
- Phone: +302 1441 654 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.