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
- Conditions
- Ankylosing Spondylitis (AS)Rheumatoid Arthritis (RA)Psoriatic Arthritis (PsA)Atopic Dermatitis (AD)
- Registration Number
- NCT04541810
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3600
- 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.
- Participants for whom the drug is contraindicated in the approved local label.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Up to approximately 6 years An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment.
Percentage of Participants Achieving Responder Status Based on Eczema Area and Severity Index (EASI) (Atopic Dermatitis Participants Only) Up to 16 weeks Responder is a participant who achieve EASI 75.
Percentage of Participants Achieving the Responder status Based on Active Joint Count (Psoriatic Arthritis Participants Only) Up to 12 weeks Responder is a participant who achieve 30% or more reduction in Tender Joint Count and Swollen Joint Count compared to Baseline.
Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only) Up to 24 weeks Responder is a participant whose DAS28 at week 24 decreased by 1.2 or more compared to baseline.
Percentage of Participants Achieving Responder Status Based on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Ankylosing Spondylitis Participants Only) Up to 12 weeks Responder is a participant whose BASDAI at week 12 decreased by 50% or more than 2 compared to the baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (116)
Inje University - Busan Paik Hospital /ID# 259143
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Kyungpook National University Hospital /ID# 251294
🇰🇷중구, Daegu Gwang Yeogsi, Korea, Republic of
Kyungpook National University Hospital /ID# 251305
🇰🇷중구, Daegu Gwang Yeogsi, Korea, Republic of
Chungnam National University Hospital /ID# 239000
🇰🇷Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of
Haeundae Bumin Hospital /ID# 238959
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Pusan National University Hospital /ID# 251315
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Chungbuk National University Hospital /ID# 262334
🇰🇷Cheongju, Chungcheongbugdo, Korea, Republic of
Inje University Haeundae Hospital /ID# 238949
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Kosin University Gospel Hospital /ID# 239001
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
SoonChunHyang University Hospital Cheonan /ID# 248379
🇰🇷Cheonan-si, Chungcheongnamdo, Korea, Republic of
SoonChunHyang University Hospital Cheonan /ID# 251302
🇰🇷Cheonan-si, Chungcheongnamdo, Korea, Republic of
Chungbuk National University Hospital /ID# 238997
🇰🇷Cheongju, Chungcheongbugdo, Korea, Republic of
Konkuk University Chungju Hospital /ID# 240936
🇰🇷Chungju, Chungcheongbugdo, Korea, Republic of
Dankook University Hospital /ID# 251307
🇰🇷Cheonan-si, Chungcheongnamdo, Korea, Republic of
Dr. Park's Internal Medicine Clinic /ID# 238995
🇰🇷Chungbuk, Chungcheongbugdo, Korea, Republic of
Daejeon Eulji Medical Center, Eulji University /ID# 251292
🇰🇷Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of
Kangwon National University Hospital /ID# 259124
🇰🇷Chuncheon, Gang Weondo, Korea, Republic of
Yonsei University-Wonju Severance Christian Hospital /ID# 239005
🇰🇷Wonju, Gang Weondo, Korea, Republic of
Chungang University Hospital /ID# 238993
🇰🇷Dongjak-gu, Gyeonggido, Korea, Republic of
Chungnam National University Hospital /ID# 259097
🇰🇷Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of
Daejeon Eulji Medical Center, Eulji University /ID# 251293
🇰🇷Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of
Konyang University Hospital /ID# 238951
🇰🇷Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of
Kangwon National University Hospital /ID# 248376
🇰🇷Chuncheon, Gang Weondo, Korea, Republic of
Catholic Kwandong University International St.Mary's Hospital /ID# 248380
🇰🇷Incheon, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital /ID# 248378
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center /ID# 251324
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center /ID# 267001
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Yonsei University-Wonju Severance Christian Hospital /ID# 239004
🇰🇷Wonju, Gang Weondo, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon /ID# 240935
🇰🇷Bucheon-si, Gyeonggido, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon /ID# 251321
🇰🇷Bucheon-si, Gyeonggido, Korea, Republic of
Korea University Ansan Hospital /ID# 238992
🇰🇷Ansan-si, Gyeonggido, Korea, Republic of
Korea University Ansan Hospital /ID# 251304
🇰🇷Ansan-si, Gyeonggido, Korea, Republic of
The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142
🇰🇷Bucheon, Gyeonggido, Korea, Republic of
Chungang University Hospital /ID# 251322
🇰🇷Dongjak-gu, Gyeonggido, Korea, Republic of
Hanyang University Guri Hospital /ID# 259173
🇰🇷Guri-si, Gyeonggido, Korea, Republic of
Hanyang University Guri Hospital /ID# 259175
🇰🇷Guri-si, Gyeonggido, Korea, Republic of
Chung-Ang University Gwangmyeong Hospital /Id# 259180
🇰🇷Gwangmyeong, Gyeonggido, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital /ID# 259177
🇰🇷Hwaseong, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital /ID# 259115
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Uijeongbu Eulji Medical Center - Eulji University /ID# 259144
🇰🇷Uijeongbu, Gyeonggido, Korea, Republic of
Uijeongbu Eulji Medical Center - Eulji University /ID# 270781
🇰🇷Uijeongbu, Gyeonggido, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182
🇰🇷Uijeongbu, Gyeonggido, Korea, Republic of
Yongin Severance Hospital /ID# 238948
🇰🇷Yongin, Gyeonggido, Korea, Republic of
Yongin Severance Hospital /ID# 251311
🇰🇷Yongin, Gyeonggido, Korea, Republic of
Inje University - Ilsan Paik Hospital /ID# 270021
🇰🇷고양시, Gyeonggido, Korea, Republic of
Chung-Ang University Gwangmyeong Hospital /ID# 270825
🇰🇷광명시, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center /ID# 262757
🇰🇷Incheon, Gyeonggido, Korea, Republic of
Hallym University Sacred Heart Hospital /ID# 259150
🇰🇷Seoul, Gyeonggido, Korea, Republic of
Ajou University Hospital /ID# 244494
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Ajou University Hospital /ID# 259123
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital /ID# 245207
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Bundang Jesaeng Hospital /ID# 238999
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Ajou University Hospital /ID# 243488
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital /ID# 259149
🇰🇷Suwon, Gyeonggido, Korea, Republic of
The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270022
🇰🇷부천시, Gyeonggido, Korea, Republic of
Daegu Catholic University Medical Center /ID# 238996
🇰🇷Daegu, Gyeongsangbugdo, Korea, Republic of
Keimyung University Dongsan Hospital /ID# 259172
🇰🇷Daegu, Gyeongsangbugdo, Korea, Republic of
Keimyung University Dongsan Hospital /ID# 269942
🇰🇷Daegu, Gyeongsangbugdo, Korea, Republic of
Dong-A University Medical Center /ID# 269937
🇰🇷Busan, Gyeongsangnamdo, Korea, Republic of
Changwon Fatima Hospital /ID# 238958
🇰🇷Changwon-si, Gyeongsangnamdo, Korea, Republic of
Samsung Changwon Hospital /ID# 239003
🇰🇷Changwon, Gyeongsangnamdo, Korea, Republic of
Gyeongsang National University Hospital /ID# 267003
🇰🇷Jinju, Gyeongsangnamdo, Korea, Republic of
Pusan National University Yangsan Hospital /ID# 239002
🇰🇷Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Pusan National University Yangsan Hospital /ID# 259120
🇰🇷Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Gyeongsang National University Changwon Hospital /ID# 269931
🇰🇷창원시, Gyeongsangnamdo, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 240934
🇰🇷Incheon, Incheon Gwang Yeogsi, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 251306
🇰🇷Incheon, Incheon Gwang Yeogsi, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 269811
🇰🇷Incheon, Incheon Gwang Yeogsi, Korea, Republic of
Inha University Hospital /ID# 251317
🇰🇷Incheon, Incheon Gwang Yeogsi, Korea, Republic of
Design Hospital /ID# 262327
🇰🇷Jeollabuk-do, Jeonrabugdo, Korea, Republic of
Jeonbuk National University Hospital /ID# 259140
🇰🇷Jeonju, Jeonrabugdo, Korea, Republic of
Chosun University Hospital /ID# 259119
🇰🇷Gwangju, Jeonranamdo, Korea, Republic of
Chonnam National University Hospital /ID# 251326
🇰🇷동구, Jeonranamdo, Korea, Republic of
Sejong Chungnam National University Hospital /ID# 238952
🇰🇷Sejong-si, Sejong, Korea, Republic of
Sejong Chungnam National University Hospital /ID# 259216
🇰🇷Sejong-si, Sejong, Korea, Republic of
Kyung Hee University Hospital /ID# 270182
🇰🇷Dongdaemun-gu, Seoul Teugbyeolsi, Korea, Republic of
Inje University Sanggye Paik Hospital /ID# 251316
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Nowon Eulji Medical Center, Eulji University /ID# 259139
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul Medical Center /ID# 251310
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Medical Center /ID# 259117
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital /ID# 262333
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 245209
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 251319
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kangbuk Samsung Hospital /ID# 238955
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kangbuk Samsung Hospital /ID# 251308
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 259178
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
SoonChunHyang University Seoul Hospital /ID# 259179
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
SoonChunHyang University Seoul Hospital /ID# 269940
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
National Medical Center /ID# 251303
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hanyang University Seoul Hospital /ID# 238640
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hanyang University Seoul Hospital /ID# 251320
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Konkuk University Medical Center /ID# 245208
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Rheuma Internal Clinic /ID# 238998
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Bone Internal Medicine /ID# 238991
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Hospital at Gangdong /ID# 267000
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Hospital at Gangdong /ID# 267004
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
VHS(Veterans Health Service) Medical Center /ID# 251323
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 251312
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Gangnam Severance Hospital /ID# 270030
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 259152
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245206
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 251314
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
SMG-SNU Boramae Medical Center /ID# 238957
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
SMG-SNU Boramae Medical Center /ID# 251325
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital /ID# 262328
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital /ID# 270775
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Ewha Womans University Seoul Hospital /ID# 251327
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Ewha Womans University Medical Centre /ID# 270025
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Guro Hospital /ID# 259141
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Myungji Hospital /Id# 259148
🇰🇷Goyang, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 248377
🇰🇷Seoul, Korea, Republic of
Duplicate_Inje University Seoul Paik Hospital /ID# 238994
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital /ID# 251328
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital /ID# 269934
🇰🇷안양시, Korea, Republic of