Clinical trial NCT04433442: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Psoriatic Arthritis
Keywords: Psoriasis
Plaque Psoriasis
Psoriatic Arthritis
Risankizumab
Skyrizi
Prefilled syringe
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 2324
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with moderate to severe plaque psoriasis or psoriatic arthritis

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants who Reported Adverse Events
timeFrame: Up to Week 72
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University - Busan Paik Hospital /ID# 238911
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Hospital /ID# 238933
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 238896
state: Busan Gwang Yeogsi
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital /ID# 238891
state: Chungcheongbugdo
city: Cheonan-si
country: Korea, Republic of
facility: Dankook University Hospital /ID# 223995
state: Chungcheongnamdo
city: Cheonan-si
country: Korea, Republic of
facility: SoonChunHyang University Hospital Cheonan /ID# 238909
state: Chungcheongnamdo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 238915
state: Daegu Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 223993
state: Daejeon Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital /ID# 238899
state: Daejeon Gwang Yeogsi
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital /ID# 238902
state: Gang Weondo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital /ID# 223989
state: Gyeonggido
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon /ID# 238894
state: Gyeonggido
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270826
state: Gyeonggido
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital /ID# 238927
state: Gyeonggido
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital /ID# 259337
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 262788
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St.Mary's Hospital /ID# 262855
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 238900
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 238916
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital /ID# 238913
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital /ID# 238930
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 238920
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital /ID# 248371
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center - Eulji University /ID# 259200
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259201
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259202
state: Gyeonggido
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital /ID# 238925
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center /ID# 238921
state: Gyeongsangbugdo
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 238932
state: Gyeongsangbugdo
city: Gyeongju-si
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital /ID# 238923
state: Gyeongsangbugdo
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 259098
state: Gyeongsangnamdo
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 238934
state: Incheon Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital /ID# 248373
state: Incheon Gwang Yeogsi
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital /ID# 238901
state: Jeonrabugdo
city: Jeollabuk-do
country: Korea, Republic of
facility: Design Hospital /ID# 238929
state: Jeonrabugdo
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 259199
state: Jeonranamdo
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital /ID# 238910
state: Jeonranamdo
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital /ID# 238918
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital /ID# 238903
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University /ID# 259198
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center /ID# 238906
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center /ID# 248375
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 238931
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 238904
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 238908
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: National Medical Center /ID# 238917
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center /ID# 223996
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: VHS(Veterans Health Service) Medical Center /ID# 238935
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 238912
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 223990
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 238919
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 248370
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 238922
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 248372
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 262789
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 270776
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital /ID# 238905
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital /ID# 238914
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center /ID# 238924
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 238928
city: Seoul
country: Korea, Republic of
facility: Duplicate_Kyunghee University Hospital at Gangdong /ID# 248369
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital /ID# 238936
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital /ID# 238937
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: