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

Psoriasis Clinical Trial

— REDEFINE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247319
• Other study ID #: P24-179
• Status: Recruiting
• Start date: April 29, 2024
• Est. completion date: October 26, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: Katerina Kollia
• Phone: +302 1441 654 75
• Email: katerina.kollia[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 26, 2027
• Est. primary completion date: October 26, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moderate Plaque Psoriasis
• Psoriasis

Locations

Country	Name	City	State
Greece	West Attica General Hospital "Agia Varvara" /ID# 266256	Agia Varvara
Greece	Dermatological and Venereological Hospital Andreas Syggros /ID# 263443	Athens
Greece	Dermatological and Venereological Hospital Andreas Syggros /ID# 266248	Athens
Greece	Hygeia Hospital /ID# 263455	Athens
Greece	University General Hospital Attikon /ID# 263442	Athens	Attiki
Greece	KAT Attica General Hospital /ID# 266249	Kifissia
Greece	University General Hospital of Larissa /ID# 263440	Larissa
Greece	Konstantopoulio General Hospital /ID# 266257	Nea Ionia	Magnisia
Greece	Olympion General Clinic /ID# 266258	Patras	Achaia
Greece	Tzaneio Prefecture General Hospital of Piraeus /ID# 263448	Pireas
Greece	Papageorgiou General Hospital /ID# 262529	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving Psoriasis Area and Severity Index (PASI) score less than or equal to 2	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.	Baseline to Week 16
Primary	Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 (include only patients with DLQI score less than or equal to 2 at Baseline)	DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no effect) to 30 (very large effect), with a higher score indicating a more impaired quality of life.	Baseline to Week 16

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