Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247319
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-01-29
Brief Title:
Study to Evaluate the Effectiveness of Risankizumab in Participants With a Recent Diagnosis of Moderate Plaque Psoriasis in a Real-life Setting in Greece
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDEFINE
Brief 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
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
Detailed Description:
Any of a variety of other sampling processes such as convenience sampling or invitation to volunteer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None