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

AbbVie

Status: Active, not recruiting

Conditions: Psoriasis; Moderate Plaque Psoriasis; Moderate Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT06247319

P24-179

Details and patient eligibility

About

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.

Full description

Any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Participants Treated with Risankizumab

Description:

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.