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.
Study Type
OBSERVATIONAL
Enrollment
2,324
Inje University - Busan Paik Hospital /ID# 238911
Busan, Busan Gwang Yeogsi, South Korea
Inje University Haeundae Hospital /ID# 238933
Busan, Busan Gwang Yeogsi, South Korea
Pusan National University Hospital /ID# 238896
Busan, Busan Gwang Yeogsi, South Korea
Dankook University Hospital /ID# 223995
Cheonan-si, Chungcheongnam-do, South Korea
SoonChunHyang University Hospital Cheonan /ID# 238909
Cheonan-si, Chungcheongnam-do, South Korea
Number of Participants who Reported Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: Up to Week 72
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Kyungpook National University Hospital /ID# 238915
Daegu, Daegu Gwang Yeogsi, South Korea
Chungnam National University Hospital /ID# 223993
Daejeon, Daejeon Gwang Yeogsi, South Korea
Konyang University Hospital /ID# 238899
Daejeon, Daejeon Gwang Yeogsi, South Korea
Kangwon National University Hospital /ID# 238902
Chuncheon, Gang Weondo, South Korea
Korea University Ansan Hospital /ID# 223989
Ansan-si, Gyeonggido, South Korea
...and 53 more locations