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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate to Severe Plaque Psoriasis or Psoriatic Arthritis | Participants will receive risankizumab as prescribed by the physician in routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 72 |
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Inclusion Criteria:
Exclusion Criteria:
- Contraindications to risankizumab as listed on the approved local label.
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Adult participants with moderate to severe plaque psoriasis or psoriatic arthritis
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University - Busan Paik Hospital /ID# 238911 | Busan | Busan Gwang Yeogsi | 47392 | South Korea | ||
| Inje University Haeundae Hospital /ID# 238933 |
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| Label | URL |
|---|---|
| Clinical Study Report Synopsis | View source |
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| Busan |
| Busan Gwang Yeogsi |
| 48108 |
| South Korea |
| Pusan National University Hospital /ID# 238896 | Busan | Busan Gwang Yeogsi | 49241 | South Korea |
| Dankook University Hospital /ID# 223995 | Cheonan-si | Chungcheongnam-do | 31116 | South Korea |
| SoonChunHyang University Hospital Cheonan /ID# 238909 | Cheonan-si | Chungcheongnam-do | 31151 | South Korea |
| Kyungpook National University Hospital /ID# 238915 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Chungnam National University Hospital /ID# 223993 | Daejeon | Daejeon Gwang Yeogsi | 35015 | South Korea |
| Konyang University Hospital /ID# 238899 | Daejeon | Daejeon Gwang Yeogsi | 35365 | South Korea |
| Kangwon National University Hospital /ID# 238902 | Chuncheon | Gang Weondo | 24289 | South Korea |
| Korea University Ansan Hospital /ID# 223989 | Ansan-si | Gyeonggido | 15355 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 238894 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270826 | Bucheon-si | Gyeonggido | 14647 | South Korea |
| Hallym University Dongtan Sacred Heart Hospital /ID# 238927 | Hwaseong | Gyeonggido | 18450 | South Korea |
| Dongguk University Ilsan Hospital /ID# 259337 | Ilsan | Gyeonggido | 10326 | South Korea |
| Gachon University Gil Medical Center /ID# 262788 | Incheon | Gyeonggido | 21565 | South Korea |
| Catholic Kwandong University International St.Mary's Hospital /ID# 262855 | Incheon | Gyeonggido | 22711 | South Korea |
| CHA Bundang Medical Center /ID# 238916 | Seongnam | Gyeonggido | 13496 | South Korea |
| Seoul National University Bundang Hospital /ID# 238900 | Seongnam-si | Gyeonggido | 13620 | South Korea |
| Hallym University Sacred Heart Hospital /ID# 238913 | Seoul | Gyeonggido | 14067 | South Korea |
| Hallym University Sacred Heart Hospital /ID# 238930 | Seoul | Gyeonggido | 14067 | South Korea |
| The Catholic University Of Korea St. Vincent's Hospital /ID# 248371 | Suwon | Gyeonggido | 16247 | South Korea |
| Ajou University Hospital /ID# 238920 | Suwon | Gyeonggido | 16499 | South Korea |
| Uijeongbu Eulji Medical Center - Eulji University /ID# 259200 | Uijeongbu-si | Gyeonggido | 11759 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259201 | Uijeongbu-si | Gyeonggido | 11765 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259202 | Uijeongbu-si | Gyeonggido | 11765 | South Korea |
| Yongin Severance Hospital /ID# 238925 | Yongin | Gyeonggido | 16995 | South Korea |
| Daegu Catholic University Medical Center /ID# 238921 | Daegu | Gyeongsangbuk-do | 42472 | South Korea |
| Keimyung University Dongsan Hospital /ID# 238932 | Daegu | Gyeongsangbuk-do | 42601 | South Korea |
| Dongguk University Gyeongju Hospital /ID# 238923 | Gyeongju | Gyeongsangbuk-do | 38067 | South Korea |
| Pusan National University Yangsan Hospital /ID# 259098 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934 | Incheon | Incheon Gwang Yeogsi | 21431 | South Korea |
| Inha University Hospital /ID# 248373 | Incheon | Incheon Gwang Yeogsi | 21565 | South Korea |
| Wonkwang University Hospital /ID# 238901 | Iksan | Jeonrabugdo | 54538 | South Korea |
| Design Hospital /ID# 238929 | Jeollabuk-do | Jeonrabugdo | 54910 | South Korea |
| Chosun University Hospital /ID# 238910 | Gwangju | Jeonranamdo | 61453 | South Korea |
| Chonnam National University Hospital /ID# 259199 | Gwangju | Jeonranamdo | 61469 | South Korea |
| Chungbuk National University Hospital /ID# 238891 | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Chungang University Hospital /ID# 238918 | Dongjak-gu | Seoul Teugbyeolsi | 06973 | South Korea |
| Inje University Sanggye Paik Hospital /ID# 238903 | Seoul | Seoul Teugbyeolsi | 01757 | South Korea |
| Nowon Eulji Medical Center, Eulji University /ID# 259198 | Seoul | Seoul Teugbyeolsi | 01830 | South Korea |
| Seoul Medical Center /ID# 238906 | Seoul | Seoul Teugbyeolsi | 02053 | South Korea |
| Kyung Hee University Hospital /ID# 248375 | Seoul | Seoul Teugbyeolsi | 02447 | South Korea |
| Korea University Anam Hospital /ID# 238931 | Seoul | Seoul Teugbyeolsi | 02841 | South Korea |
| Seoul National University Hospital /ID# 238904 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Kangbuk Samsung Hospital /ID# 238908 | Seoul | Seoul Teugbyeolsi | 03181 | South Korea |
| National Medical Center /ID# 238917 | Seoul | Seoul Teugbyeolsi | 04564 | South Korea |
| Konkuk University Medical Center /ID# 223996 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| VHS(Veterans Health Service) Medical Center /ID# 238935 | Seoul | Seoul Teugbyeolsi | 05368 | South Korea |
| Asan Medical Center /ID# 238912 | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Gangnam Severance Hospital /ID# 223990 | Seoul | Seoul Teugbyeolsi | 06273 | South Korea |
| Samsung Medical Center /ID# 238919 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 248370 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 238922 | Seoul | Seoul Teugbyeolsi | 07061 | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 248372 | Seoul | Seoul Teugbyeolsi | 07345 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 262789 | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 270776 | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Korea University Guro Hospital /ID# 238905 | Seoul | Seoul Teugbyeolsi | 08308 | South Korea |
| Kyungpook National University Chilgok Hospital /ID# 238914 | Daegu | 41404 | South Korea |
| Yeungnam University Medical Center /ID# 238924 | Daegu | 42415 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 238928 | Seoul | 03722 | South Korea |
| Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369 | Seoul | 05278 | South Korea |
| Hallym University Kangdong Sacred Heart Hospital /ID# 238936 | Seoul | 05355 | South Korea |
| Hallym University Kangdong Sacred Heart Hospital /ID# 238937 | Seoul | 05355 | South Korea |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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