Assessing the safety and symptom changes of Risankizumab in adults with moderate to severe psoriasis and psoriatic arthritis
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Risankizumab (Skyrizi) in Adult Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis Patients
AbbVie · NCT04433442
This study is testing if Risankizumab can safely help adults with moderate to severe psoriasis and psoriatic arthritis feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AbbVie (industry) |
| Drugs / interventions | risankizumab |
| Locations | 63 sites (Busan, Busan Gwang Yeogsi and 62 other locations) |
| Trial ID | NCT04433442 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Risankizumab, an approved treatment for moderate to severe plaque psoriasis and psoriatic arthritis, in adult participants. Approximately 3000 adults who have been prescribed Risankizumab will be enrolled across multiple sites in Korea. The study aims to assess changes in disease symptoms and monitor any adverse effects associated with the treatment. Participants will receive the medication via prefilled syringes as part of their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates include adults with moderate to severe plaque psoriasis or psoriatic arthritis who are suitable for treatment with Risankizumab.
Not a fit: Patients who have contraindications to Risankizumab as listed on the approved local label will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of Risankizumab for patients suffering from these chronic conditions.
How similar studies have performed: Other studies have shown positive outcomes with Risankizumab in treating psoriasis and psoriatic arthritis, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Busan, Busan Gwang Yeogsi and 62 other locations
- Inje University - Busan Paik Hospital /ID# 238911 — Busan, Busan Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Inje University Haeundae Hospital /ID# 238933 — Busan, Busan Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Pusan National University Hospital /ID# 238896 — Busan, Busan Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Chungbuk National University Hospital /ID# 238891 — Cheongju, Chungcheongbugdo, Korea, Republic of (RECRUITING)
- Dankook University Hospital /ID# 223995 — Cheonan-si, Chungcheongnamdo, Korea, Republic of (RECRUITING)
- SoonChunHyang University Hospital Cheonan /ID# 238909 — Cheonan-si, Chungcheongnamdo, Korea, Republic of (RECRUITING)
- Kyungpook National University Hospital /ID# 238915 — 중구, Daegu Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Chungnam National University Hospital /ID# 223993 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Konyang University Hospital /ID# 238899 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Kangwon National University Hospital /ID# 238902 — Chuncheon, Gang Weondo, Korea, Republic of (RECRUITING)
- Korea University Ansan Hospital /ID# 223989 — Ansan-si, Gyeonggido, Korea, Republic of (RECRUITING)
- Soon Chun Hyang University Hospital Bucheon /ID# 238894 — Bucheon-si, Gyeonggido, Korea, Republic of (RECRUITING)
- Chungang University Hospital /ID# 238918 — Dongjak-gu, Gyeonggido, Korea, Republic of (RECRUITING)
- Hallym University Dongtan Sacred Heart Hospital /ID# 238927 — Hwaseong, Gyeonggido, Korea, Republic of (RECRUITING)
- Dongguk University Ilsan Hospital /ID# 259337 — Ilsan, Gyeonggido, Korea, Republic of (RECRUITING)
- Gachon University Gil Medical Center /ID# 262788 — Incheon, Gyeonggido, Korea, Republic of (RECRUITING)
- Catholic Kwandong University International St.Mary's Hospital /ID# 262855 — Incheon, Gyeonggido, Korea, Republic of (RECRUITING)
- Seoul National University Bundang Hospital /ID# 238900 — Seongnam-si, Gyeonggido, Korea, Republic of (RECRUITING)
- CHA Bundang Medical Center /ID# 238916 — Seongnam, Gyeonggido, Korea, Republic of (RECRUITING)
- Hallym University Sacred Heart Hospital /ID# 238913 — Seoul, Gyeonggido, Korea, Republic of (RECRUITING)
- Hallym University Sacred Heart Hospital /ID# 238930 — Seoul, Gyeonggido, Korea, Republic of (RECRUITING)
- Ajou University Hospital /ID# 238920 — Suwon-si, Gyeonggido, Korea, Republic of (RECRUITING)
- The Catholic University Of Korea St. Vincent's Hospital /ID# 248371 — Suwon, Gyeonggido, Korea, Republic of (RECRUITING)
- Uijeongbu Eulji Medical Center - Eulji University /ID# 259200 — Uijeongbu, Gyeonggido, Korea, Republic of (RECRUITING)
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259201 — Uijeongbu, Gyeonggido, Korea, Republic of (RECRUITING)
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259202 — Uijeongbu, Gyeonggido, Korea, Republic of (RECRUITING)
- The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270826 — 부천시, Gyeonggido, Korea, Republic of (RECRUITING)
- Daegu Catholic University Medical Center /ID# 238921 — Daegu, Gyeongsangbugdo, Korea, Republic of (RECRUITING)
- Keimyung University Dongsan Hospital /ID# 238932 — Daegu, Gyeongsangbugdo, Korea, Republic of (RECRUITING)
- Dongguk University Gyeongju Hospital /ID# 238923 — Gyeongju-si, Gyeongsangbugdo, Korea, Republic of (RECRUITING)
- Pusan National University Yangsan Hospital /ID# 259098 — Yangsan-si, Gyeongsangnamdo, Korea, Republic of (RECRUITING)
- The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934 — Incheon, Incheon Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Inha University Hospital /ID# 248373 — Incheon, Incheon Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Design Hospital /ID# 238929 — Jeollabuk-do, Jejudo, Korea, Republic of (RECRUITING)
- Yongin Severance Hospital /ID# 238925 — Yongin, Jejudo, Korea, Republic of (RECRUITING)
- Wonkwang University Hospital /ID# 238901 — Iksan, Jeonrabugdo, Korea, Republic of (RECRUITING)
- Chosun University Hospital /ID# 238910 — Gwangju, Jeonranamdo, Korea, Republic of (RECRUITING)
- Chonnam National University Hospital /ID# 259199 — 동구, Jeonranamdo, Korea, Republic of (RECRUITING)
- Inje University Sanggye Paik Hospital /ID# 238903 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Nowon Eulji Medical Center, Eulji University /ID# 259198 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Seoul Medical Center /ID# 238906 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Kyung Hee University Medical Center /ID# 248375 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Korea University Anam Hospital /ID# 238931 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Seoul National University Hospital /ID# 238904 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Kangbuk Samsung Hospital /ID# 238908 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- National Medical Center /ID# 238917 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Konkuk University Medical Center /ID# 223996 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- VHS(Veterans Health Service) Medical Center /ID# 238935 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Asan Medical Center /ID# 238912 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Gangnam Severance Hospital /ID# 223990 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
+13 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Celine Im
- Email: celine.im@abbvie.com
- Phone: +82-10-2230-3629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psoriasis, Psoriatic Arthritis, Plaque Psoriasis, Risankizumab, Skyrizi, Prefilled syringe