Psoriasis Clinical Trial
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
| NCT number | NCT04433442 |
| Other study ID # | P20-271 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 4, 2020 |
| Est. completion date | March 30, 2025 |
| Verified date | June 2024 |
| Source | AbbVie |
| Contact | Celine Im |
| Phone | 847.283.8955 |
| celine.im[@]abbvie.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | March 30, 2025 |
| Est. primary completion date | March 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: - Suitable for the treatment with risankizumab according to the approved local label. - Voluntarily agree to participate in this study and sign informed consent. Exclusion Criteria: - Contraindications to risankizumab as listed on the approved local label. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Kyungpook National University Hospital /ID# 238915 | ?? | Daegu Gwang Yeogsi |
| Korea, Republic of | Korea University Ansan Hospital /ID# 223989 | Ansan-si | Gyeonggido |
| Korea, Republic of | Soon Chun Hyang University Hospital Bucheon /ID# 238894 | Bucheon-si | Gyeonggido |
| Korea, Republic of | Inje University - Busan Paik Hospital /ID# 238911 | Busan | Busan Gwang Yeogsi |
| Korea, Republic of | Inje University Haeundae Hospital /ID# 238933 | Busan | |
| Korea, Republic of | Pusan National University Hospital /ID# 238896 | Busan | |
| Korea, Republic of | Dankook University Hospital /ID# 223995 | Cheonan-si | Chungcheongnamdo |
| Korea, Republic of | SoonChunHyang University Hospital Cheonan /ID# 238909 | Cheonan-si | Chungcheongnamdo |
| Korea, Republic of | Chungbuk National University Hospital /ID# 238891 | Cheongju | Chungcheongbugdo |
| Korea, Republic of | Kangwon National University Hospital /ID# 238902 | Chuncheon | Gang Weondo |
| Korea, Republic of | Daegu Catholic University Medical Center /ID# 238921 | Daegu | Gyeongsangbugdo |
| Korea, Republic of | Keimyung University Dongsan Hospital /ID# 238932 | Daegu | Gyeongsangbugdo |
| Korea, Republic of | Kyungpook National University Chilgok Hospital /ID# 238914 | Daegu | |
| Korea, Republic of | Yeungnam University Medical Center /ID# 238924 | Daegu | |
| Korea, Republic of | Chungnam National University Hospital /ID# 223993 | Daejeon | Daejeon Gwang Yeogsi |
| Korea, Republic of | Konyang University Hospital /ID# 238899 | Daejeon | Daejeon Gwang Yeogsi |
| Korea, Republic of | Chungang University Hospital /ID# 238918 | Dongjak-gu | Gyeonggido |
| Korea, Republic of | Chosun University Hospital /ID# 238910 | Gwangju | Jeonranamdo |
| Korea, Republic of | Dongguk University Gyeongju Hospital /ID# 238923 | Gyeongju-si | Gyeongsangbugdo |
| Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital /ID# 238927 | Hwaseong | Gyeonggido |
| Korea, Republic of | Wonkwang University Hospital /ID# 238901 | Iksan | Jeonrabugdo |
| Korea, Republic of | Inha University Hospital /ID# 248373 | Incheon | Incheon Gwang Yeogsi |
| Korea, Republic of | The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934 | Incheon | Incheon Gwang Yeogsi |
| Korea, Republic of | Design Hospital /ID# 238929 | Jeollabuk-do | |
| Korea, Republic of | CHA Bundang Medical Center /ID# 238916 | Seongnam | Gyeonggido |
| Korea, Republic of | Seoul National University Bundang Hospital /ID# 238900 | Seongnam-si | Gyeonggido |
| Korea, Republic of | Asan Medical Center /ID# 238912 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369 | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital /ID# 223990 | Seoul | |
| Korea, Republic of | Hallym University Kangdong Sacred Heart Hospital /ID# 238936 | Seoul | |
| Korea, Republic of | Hallym University Kangdong Sacred Heart Hospital /ID# 238937 | Seoul | |
| Korea, Republic of | Hallym University Sacred Heart Hospital /ID# 238913 | Seoul | Gyeonggido |
| Korea, Republic of | Hallym University Sacred Heart Hospital /ID# 238930 | Seoul | Gyeonggido |
| Korea, Republic of | Inje University Sanggye Paik Hospital /ID# 238903 | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital /ID# 238908 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Konkuk University Medical Center /ID# 223996 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Korea University Anam Hospital /ID# 238931 | Seoul | |
| Korea, Republic of | Korea University Guro Hospital /ID# 238905 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Kyung Hee University Medical Center /ID# 248375 | Seoul | |
| Korea, Republic of | National Medical Center /ID# 238917 | Seoul | |
| Korea, Republic of | Samsung Medical Center /ID# 238919 | Seoul | |
| Korea, Republic of | Seoul Medical Center /ID# 238906 | Seoul | |
| Korea, Republic of | Seoul National University Hospital /ID# 238904 | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center /ID# 238922 | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Seoul St. Marys Hospital /ID# 248370 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 248372 | Seoul | |
| Korea, Republic of | VHS(Veterans Health Service) Medical Center /ID# 238935 | Seoul | |
| Korea, Republic of | Yonsei University Health System Severance Hospital /ID# 238928 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital /ID# 248371 | Suwon | Gyeonggido |
| Korea, Republic of | Ajou University Hospital /ID# 238920 | Suwon-si | Gyeonggido |
| Korea, Republic of | Yongin Severance Hospital /ID# 238925 | Yongin |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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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