Clinical trial NCT04541810: A Study of Oral Upadacitinib (RINVOQ) Tablets to Assess Adverse Events and Change in Disease Symptoms in Korean Participants With Moderate to Severe Active Rheumatoid Arthritis, Atopic Dermatitis, Ankylosing Spondylitis or Psoriatic Arthritis
Official title: Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib in Korean Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis (RA)
Atopic Dermatitis (AD)
Ankylosing Spondylitis (AS)
Psoriatic Arthritis (PsA)
Keywords: Rheumatoid Arthritis
Atopic Dermatitis (AD)
Ankylosing Spondylitis (AS)
Psoriatic Arthritis (PsA)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 3600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving Upadacitinib according to the product prescribing information, for moderate to severe active Rheumatoid Arthritis (RA), Atopic Dermatitis (AD), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA).

Brief summary: Rheumatoid Arthritis (RA) is an inflammatory disease of the joints characterized by the swelling of multiple joints and tenderness caused by progressive inflammatory synovitis, which leads to serious and debilitating diseases. Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Ankylosing Spondylitis (AS) is a form of chronic arthritis causing inflammation in the spine. This can cause pain and stiffness in the back. 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 the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. This study will assess the adverse events and change in disease symptoms in Korean participants with RA, AD, AS or PsA.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis, atopic dermatitis, ankylosing spondylitis or psoriatic arthritis. Korean participants who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 3600 participants will be enrolled this study, in multiple sites within Korea.

Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 28 weeks.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility criteria: Inclusion Criteria:

* Adult participants (\>= 19 years of age), Atopic dermatitis includes both adolescents (\>= 12 years of age) and adults.
* Participants suitable for the treatment with upadacitinib according to the approved local label.

Exclusion Criteria:

- Participants for whom the drug is contraindicated in the approved local label.

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 6 years
measure: Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only)
timeFrame: Up to 24 weeks
measure: Percentage of Participants Achieving Responder Status Based on Eczema Area and Severity Index (EASI) (Atopic Dermatitis Participants Only)
timeFrame: Up to 16 weeks
measure: Percentage of Participants Achieving Responder Status Based on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Ankylosing Spondylitis Participants Only)
timeFrame: Up to 12 weeks
measure: Percentage of Participants Achieving the Responder status Based on Active Joint Count (Psoriatic Arthritis Participants Only)
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University - Busan Paik Hospital /ID# 259143
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Haeundae Bumin Hospital /ID# 238959
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Hospital /ID# 238949
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 251315
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital /ID# 239001
state: Busan Gwang Yeogsi
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital /ID# 238997
state: Chungcheongbugdo
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital /ID# 262334
state: Chungcheongbugdo
city: Chungbuk
country: Korea, Republic of
facility: Dr. Park's Internal Medicine Clinic /ID# 238995
state: Chungcheongbugdo
city: Chungju
country: Korea, Republic of
facility: Konkuk University Chungju Hospital /ID# 240936
state: Chungcheongbugdo
city: Cheonan-si
country: Korea, Republic of
facility: Dankook University Hospital /ID# 251307
state: Chungcheongnamdo
city: Cheonan-si
country: Korea, Republic of
facility: SoonChunHyang University Hospital Cheonan /ID# 248379
state: Chungcheongnamdo
city: Cheonan-si
country: Korea, Republic of
facility: SoonChunHyang University Hospital Cheonan /ID# 251302
state: Chungcheongnamdo
city: 중구
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 251294
state: Daegu Gwang Yeogsi
city: 중구
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 251305
state: Daegu Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 239000
state: Daejeon Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 259097
state: Daejeon Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center, Eulji University /ID# 251292
state: Daejeon Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center, Eulji University /ID# 251293
state: Daejeon Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital /ID# 238951
state: Daejeon Gwang Yeogsi
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital /ID# 248376
state: Gang Weondo
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital /ID# 259124
state: Gang Weondo
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital /ID# 239004
state: Gang Weondo
city: Wonju
country: Korea, Republic of
facility: Yonsei University-Wonju Severance Christian Hospital /ID# 239005
state: Gang Weondo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital /ID# 238992
state: Gyeonggido
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital /ID# 251304
state: Gyeonggido
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon /ID# 240935
state: Gyeonggido
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon /ID# 251321
state: Gyeonggido
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142
state: Gyeonggido
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital /ID# 238993
state: Gyeonggido
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital /ID# 251322
state: Gyeonggido
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital /ID# 259173
state: Gyeonggido
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital /ID# 259175
state: Gyeonggido
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital /Id# 259180
state: Gyeonggido
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital /ID# 259177
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 262757
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St.Mary's Hospital /ID# 248380
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 248378
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 259115
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 251324
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 267001
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Bundang Jesaeng Hospital /ID# 238999
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital /ID# 259150
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 243488
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 244494
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 259123
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital /ID# 245207
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital /ID# 259149
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center - Eulji University /ID# 259144
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center - Eulji University /ID# 270781
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182
state: Gyeonggido
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital /ID# 238948
state: Gyeonggido
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital /ID# 251311
state: Gyeonggido
city: 고양시
country: Korea, Republic of
facility: Inje University - Ilsan Paik Hospital /ID# 270021
state: Gyeonggido
city: 광명시
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital /ID# 270825
state: Gyeonggido
city: 부천시
country: Korea, Republic of
facility: The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270022
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center /ID# 238996
state: Gyeongsangbugdo
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 259172
state: Gyeongsangbugdo
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 269942
state: Gyeongsangbugdo
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center /ID# 269937
state: Gyeongsangnamdo
city: Changwon-si
country: Korea, Republic of
facility: Changwon Fatima Hospital /ID# 238958
state: Gyeongsangnamdo
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital /ID# 239003
state: Gyeongsangnamdo
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital /ID# 267003
state: Gyeongsangnamdo
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 239002
state: Gyeongsangnamdo
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 259120
state: Gyeongsangnamdo
city: 창원시
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital /ID# 269931
state: Gyeongsangnamdo
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 240934
state: Incheon Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 251306
state: Incheon Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 269811
state: Incheon Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital /ID# 251317
state: Incheon Gwang Yeogsi
city: Jeollabuk-do
country: Korea, Republic of
facility: Design Hospital /ID# 262327
state: Jeonrabugdo
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital /ID# 259140
state: Jeonrabugdo
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital /ID# 259119
state: Jeonranamdo
city: 동구
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 251326
state: Jeonranamdo
city: Sejong-si
country: Korea, Republic of
facility: Sejong Chungnam National University Hospital /ID# 238952
state: Sejong
city: Sejong-si
country: Korea, Republic of
facility: Sejong Chungnam National University Hospital /ID# 259216
state: Sejong
city: Dongdaemun-gu
country: Korea, Republic of
facility: Kyung Hee University Hospital /ID# 270182
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital /ID# 251316
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University /ID# 259139
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center /ID# 251310
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center /ID# 259117
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 262333
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 245209
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 251319
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 238955
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 251308
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 259178
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul Hospital /ID# 259179
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul Hospital /ID# 269940
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: National Medical Center /ID# 251303
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 238640
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 251320
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center /ID# 245208
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Rheuma Internal Clinic /ID# 238998
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Bone Internal Medicine /ID# 238991
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong /ID# 267000
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong /ID# 267004
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: VHS(Veterans Health Service) Medical Center /ID# 251323
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 251312
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 270030
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 259152
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245206
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 251314
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 238957
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 251325
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 262328
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 270775
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital /ID# 251327
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Centre /ID# 270025
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital /ID# 259141
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956
state: Seoul Teugbyeolsi
city: Goyang
country: Korea, Republic of
facility: Myungji Hospital /Id# 259148
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 248377
city: Seoul
country: Korea, Republic of
facility: Duplicate_Inje University Seoul Paik Hospital /ID# 238994
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital /ID# 251328
city: 안양시
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital /ID# 269934
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: