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NCT06247319Active, not recruiting

Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting 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

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
250 (actual)
First submitted
29 Jan 2024
Start date
29 Apr 2024
Primary completion date
Oct 2027
Lead sponsor
AbbVie
Diseases
Psoriasis
NCT number
NCT06247319

What you commit to

  • Study type: Observational
  • Participants enrolled: 250
  • From 29 Apr 2024 to the primary completion date, Oct 2027
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days before risankizumab initiation

Other

  • Pregnancy or lactation
  • Unwilling or unable to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
West Attica General Hospital "Agia Varvara" /ID# 266256
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Agía VarváraGreeceUnknown status
General Hospital Andreas Syggros /ID# 266248
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AthensGreeceUnknown status
401 General Military Hospital /ID# 277393
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AthensGreeceUnknown status
Iatriko Psichikou /ID# 272851
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AthensGreeceUnknown status
University General Hospital Attikon /ID# 263442
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AthensGreeceUnknown status
251 Hellenic Air Force General Hospital /ID# 268135
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AthensGreeceUnknown status
Hygeia Hospital /ID# 263455
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AthensGreeceUnknown status
General Hospital Andreas Syggros /ID# 263443
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AthensGreeceUnknown status
Venizelio Regional General Hospital of Heraklion /ID# 268778
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HeraklionGreeceUnknown status
University General Hospital of Heraklion /ID# 268777
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HeraklionGreeceUnknown status
KAT Attica General Hospital /ID# 266249
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KifissiaGreeceUnknown status
University General Hospital of Larissa /ID# 263440
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LarissaGreeceUnknown status
Konstantopoulio General Hospital /ID# 266257
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Nea IoniaGreeceUnknown status
Olympion General Clinic /ID# 266258
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PátraiGreeceUnknown status
Tzaneio Prefecture General Hospital of Piraeus /ID# 263448
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PiraeusGreeceUnknown status
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 262530
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ThessalonikiGreeceUnknown status
Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 263452
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ThessalonikiGreeceUnknown status
Papageorgiou General Hospital /ID# 262529
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ThessalonikiGreeceUnknown status
General Hospital of Thessaloniki "Agios Pavlos'' /ID# 267506
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ThessalonikiGreeceUnknown status
General Hospital of Tripoli Panarkadiko "Evangelistria" /ID# 266251
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TripoliGreeceUnknown status
Asklipieio General Hospital of Voula /ID# 268136
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VoulaGreeceUnknown status
General Hospital of Xanthi /ID# 268133
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XánthiGreeceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.