Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433442
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2020-06-04
Brief Title:
Study to Assess the Safety and Change in Disease Symptoms of Risankizumab Skyrizi in Adult Participants With Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Risankizumab Skyrizi in Adult Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis Patients
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:
None
Brief Summary:
Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin Psoriatic arthritis PsA is a type of arthritis swelling and stiffness in the joints that is frequently seen in trial participants who also have the skin condition psoriasis It is caused by an overactive immune system where the body attacks healthy tissue by mistake This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis or psoriatic arthritis and to assess change in disease symptoms
Risankizumab is an approved drug for the treatment of psoriasis and psoriatic arthritis Around 3000 adult participants with a moderate to severe plaque psoriasis or psoriatic arthritis who had been prescribed risankizumab by their doctor will be enrolled in this study in multiple sites across Korea The sample size for this study is a requirement by local authorities
Participants will receive risankizumab prefilled syringe for injection for 52 weeks as prescribed by their physician
There is expected to be no additional burden for participants in this study All study visits will occur during routine clinical practice and participants will be followed for 52 weeks
Risankizumab is an approved drug for the treatment of psoriasis and psoriatic arthritis Around 3000 adult participants with a moderate to severe plaque psoriasis or psoriatic arthritis who had been prescribed risankizumab by their doctor will be enrolled in this study in multiple sites across Korea The sample size for this study is a requirement by local authorities
Participants will receive risankizumab prefilled syringe for injection for 52 weeks as prescribed by their physician
There is expected to be no additional burden for participants in this study All study visits will occur during routine clinical practice and participants will be followed for 52 weeks
Detailed Description:
None
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