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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Upadacitinib | Participants receiving Upadacitinib as prescribed by their physician per local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | 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. | Up to approximately 6 years |
| Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only) | Responder is a participant whose DAS28 at week 24 decreased by 1.2 or more compared to baseline. | Up to 24 weeks |
| Percentage of Participants Achieving Responder Status Based on Eczema Area and Severity Index (EASI) (Atopic Dermatitis Participants Only) | Responder is a participant who achieve EASI 75. | Up to 16 weeks |
| Percentage of Participants Achieving Responder Status Based on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Ankylosing Spondylitis Participants Only) | Responder is a participant whose BASDAI at week 12 decreased by 50% or more than 2 compared to the baseline. | Up to 12 weeks |
| Percentage of Participants Achieving the Responder status Based on Active Joint Count (Psoriatic Arthritis Participants Only) | Responder is a participant who achieve 30% or more reduction in Tender Joint Count and Swollen Joint Count compared to Baseline. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Participants for whom the drug is contraindicated in the approved local label.
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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).
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University - Busan Paik Hospital /ID# 259143 | Busan | Busan Gwang Yeogsi | 47392 | South Korea | ||
| Haeundae Bumin Hospital /ID# 238959 |
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| Busan |
| Busan Gwang Yeogsi |
| 48059 |
| South Korea |
| Inje University Haeundae Hospital /ID# 238949 | Busan | Busan Gwang Yeogsi | 48108 | South Korea |
| Dong-A University Medical Center /ID# 269937 | Busan | Busan Gwang Yeogsi | 49201 | South Korea |
| Pusan National University Hospital /ID# 251315 | Busan | Busan Gwang Yeogsi | 49241 | South Korea |
| Kosin University Gospel Hospital /ID# 239001 | Busan | Busan Gwang Yeogsi | 49267 | South Korea |
| Dankook University Hospital /ID# 251307 | Cheonan-si | Chungcheongnam-do | 31116 | South Korea |
| SoonChunHyang University Hospital Cheonan /ID# 248379 | Cheonan-si | Chungcheongnam-do | 31151 | South Korea |
| SoonChunHyang University Hospital Cheonan /ID# 251302 | Cheonan-si | Chungcheongnam-do | 31151 | South Korea |
| Kyungpook National University Hospital /ID# 251294 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Kyungpook National University Hospital /ID# 251305 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Chungnam National University Hospital /ID# 239000 | Daejeon | Daejeon Gwang Yeogsi | 35015 | South Korea |
| Chungnam National University Hospital /ID# 259097 | Daejeon | Daejeon Gwang Yeogsi | 35015 | South Korea |
| Daejeon Eulji Medical Center, Eulji University /ID# 251292 | Daejeon | Daejeon Gwang Yeogsi | 35233 | South Korea |
| Daejeon Eulji Medical Center, Eulji University /ID# 251293 | Daejeon | Daejeon Gwang Yeogsi | 35233 | South Korea |
| Konyang University Hospital /ID# 238951 | Daejeon | Daejeon Gwang Yeogsi | 35365 | South Korea |
| Kangwon National University Hospital /ID# 248376 | Chuncheon | Gang Weondo | 24289 | South Korea |
| Kangwon National University Hospital /ID# 259124 | Chuncheon | Gang Weondo | 24289 | South Korea |
| Yonsei University-Wonju Severance Christian Hospital /ID# 239004 | Wŏnju | Gang Weondo | 26426 | South Korea |
| Yonsei University-Wonju Severance Christian Hospital /ID# 239005 | Wŏnju | Gang Weondo | 26426 | South Korea |
| Korea University Ansan Hospital /ID# 238992 | Ansan-si | Gyeonggido | 15355 | South Korea |
| Korea University Ansan Hospital /ID# 251304 | Ansan-si | Gyeonggido | 15355 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 240935 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 251321 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270022 | Bucheon-si | Gyeonggido | 14647 | South Korea |
| The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142 | Bucheon-si | Gyeonggido | 14647 | South Korea |
| Inje University - Ilsan Paik Hospital /ID# 270021 | Goyang | Gyeonggido | 10380 | South Korea |
| Hanyang University Guri Hospital /ID# 259173 | Guri-si | Gyeonggido | 11923 | South Korea |
| Hanyang University Guri Hospital /ID# 259175 | Guri-si | Gyeonggido | 11923 | South Korea |
| Chung-Ang University Gwangmyeong Hospital /Id# 259180 | Gwangmyeong | Gyeonggido | 04401 | South Korea |
| Chung-Ang University Gwangmyeong Hospital /ID# 270825 | Gwangmyeong | Gyeonggido | 14353 | South Korea |
| Hallym University Dongtan Sacred Heart Hospital /ID# 259177 | Hwaseong | Gyeonggido | 18450 | South Korea |
| Gachon University Gil Medical Center /ID# 262757 | Incheon | Gyeonggido | 21565 | South Korea |
| Catholic Kwandong University International St.Mary's Hospital /ID# 248380 | Incheon | Gyeonggido | 22711 | South Korea |
| CHA Bundang Medical Center /ID# 251324 | Seongnam | Gyeonggido | 13496 | South Korea |
| CHA Bundang Medical Center /ID# 267001 | Seongnam | Gyeonggido | 13496 | South Korea |
| Bundang Jesaeng Hospital /ID# 238999 | Seongnam | Gyeonggido | 13590 | South Korea |
| Seoul National University Bundang Hospital /ID# 248378 | Seongnam-si | Gyeonggido | 13620 | South Korea |
| Seoul National University Bundang Hospital /ID# 259115 | Seongnam-si | Gyeonggido | 13620 | South Korea |
| Hallym University Sacred Heart Hospital /ID# 259150 | Seoul | Gyeonggido | 14067 | South Korea |
| The Catholic University Of Korea St. Vincent's Hospital /ID# 245207 | Suwon | Gyeonggido | 16247 | South Korea |
| The Catholic University Of Korea St. Vincent's Hospital /ID# 259149 | Suwon | Gyeonggido | 16247 | South Korea |
| Ajou University Hospital /ID# 243488 | Suwon | Gyeonggido | 16499 | South Korea |
| Ajou University Hospital /ID# 244494 | Suwon | Gyeonggido | 16499 | South Korea |
| Ajou University Hospital /ID# 259123 | Suwon | Gyeonggido | 16499 | South Korea |
| Uijeongbu Eulji Medical Center - Eulji University /ID# 259144 | Uijeongbu-si | Gyeonggido | 11759 | South Korea |
| Uijeongbu Eulji Medical Center - Eulji University /ID# 270781 | Uijeongbu-si | Gyeonggido | 11759 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182 | Uijeongbu-si | Gyeonggido | 11765 | South Korea |
| Yongin Severance Hospital /ID# 238948 | Yongin | Gyeonggido | 16995 | South Korea |
| Yongin Severance Hospital /ID# 251311 | Yongin | Gyeonggido | 16995 | South Korea |
| Daegu Catholic University Medical Center /ID# 238996 | Daegu | Gyeongsangbuk-do | 42472 | South Korea |
| Keimyung University Dongsan Hospital /ID# 259172 | Daegu | Gyeongsangbuk-do | 42601 | South Korea |
| Keimyung University Dongsan Hospital /ID# 269942 | Daegu | Gyeongsangbuk-do | 42601 | South Korea |
| Samsung Changwon Hospital /ID# 239003 | Changwon | Gyeongsangnam-do | 51353 | South Korea |
| Changwon Fatima Hospital /ID# 238958 | Changwon-si | Gyeongsangnam-do | 51394 | South Korea |
| Gyeongsang National University Changwon Hospital /ID# 269931 | Changwon-si | Gyeongsangnam-do | 51472 | South Korea |
| Gyeongsang National University Hospital /ID# 267003 | Jinju | Gyeongsangnam-do | 52727 | South Korea |
| Pusan National University Yangsan Hospital /ID# 239002 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Pusan National University Yangsan Hospital /ID# 259120 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 240934 | Incheon | Incheon Gwang Yeogsi | 21431 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 251306 | Incheon | Incheon Gwang Yeogsi | 21431 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 269811 | Incheon | Incheon Gwang Yeogsi | 21431 | South Korea |
| Inha University Hospital /ID# 251317 | Incheon | Incheon Gwang Yeogsi | 21565 | South Korea |
| Design Hospital /ID# 262327 | Jeollabuk-do | Jeonrabugdo | 54910 | South Korea |
| Jeonbuk National University Hospital /ID# 259140 | Jeonju | Jeonrabugdo | 54907 | South Korea |
| Chosun University Hospital /ID# 259119 | Gwangju | Jeonranamdo | 61453 | South Korea |
| Chonnam National University Hospital /ID# 251326 | Gwangju | Jeonranamdo | 61469 | South Korea |
| Chungbuk National University Hospital /ID# 238997 | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Chungbuk National University Hospital /ID# 262334 | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Dr. Park's Internal Medicine Clinic /ID# 238995 | Chungbuk | North Chungcheong | 28641 | South Korea |
| Konkuk University Chungju Hospital /ID# 240936 | Chungju | North Chungcheong | 27376 | South Korea |
| Sejong Chungnam National University Hospital /ID# 238952 | Sejong-si | Sejong-si | 30099 | South Korea |
| Sejong Chungnam National University Hospital /ID# 259216 | Sejong-si | Sejong-si | 30099 | South Korea |
| Chungang University Hospital /ID# 238993 | Dongjak-gu | Seoul Teugbyeolsi | 06973 | South Korea |
| Chungang University Hospital /ID# 251322 | Dongjak-gu | Seoul Teugbyeolsi | 06973 | South Korea |
| Inje University Sanggye Paik Hospital /ID# 251316 | Seoul | Seoul Teugbyeolsi | 01757 | South Korea |
| Nowon Eulji Medical Center, Eulji University /ID# 259139 | Seoul | Seoul Teugbyeolsi | 01830 | South Korea |
| Seoul Medical Center /ID# 251310 | Seoul | Seoul Teugbyeolsi | 02053 | South Korea |
| Kyung Hee University Hospital /ID# 259117 | Seoul | Seoul Teugbyeolsi | 02447 | South Korea |
| Kyung Hee University Hospital /ID# 270182 | Seoul | Seoul Teugbyeolsi | 02447 | South Korea |
| Korea University Anam Hospital /ID# 262333 | Seoul | Seoul Teugbyeolsi | 02841 | South Korea |
| Seoul National University Hospital /ID# 245209 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Seoul National University Hospital /ID# 251319 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Kangbuk Samsung Hospital /ID# 238955 | Seoul | Seoul Teugbyeolsi | 03181 | South Korea |
| Kangbuk Samsung Hospital /ID# 251308 | Seoul | Seoul Teugbyeolsi | 03181 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 259178 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| SoonChunHyang University Seoul Hospital /ID# 259179 | Seoul | Seoul Teugbyeolsi | 04401 | South Korea |
| SoonChunHyang University Seoul Hospital /ID# 269940 | Seoul | Seoul Teugbyeolsi | 04401 | South Korea |
| National Medical Center /ID# 251303 | Seoul | Seoul Teugbyeolsi | 04564 | South Korea |
| Hanyang University Seoul Hospital /ID# 238640 | Seoul | Seoul Teugbyeolsi | 04763 | South Korea |
| Hanyang University Seoul Hospital /ID# 251320 | Seoul | Seoul Teugbyeolsi | 04763 | South Korea |
| Konkuk University Medical Center /ID# 245208 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| Rheuma Internal Clinic /ID# 238998 | Seoul | Seoul Teugbyeolsi | 05119 | South Korea |
| Asan Bone Internal Medicine /ID# 238991 | Seoul | Seoul Teugbyeolsi | 05257 | South Korea |
| Kyung Hee University Hospital at Gangdong /ID# 267000 | Seoul | Seoul Teugbyeolsi | 05278 | South Korea |
| Kyung Hee University Hospital at Gangdong /ID# 267004 | Seoul | Seoul Teugbyeolsi | 05278 | South Korea |
| VHS(Veterans Health Service) Medical Center /ID# 251323 | Seoul | Seoul Teugbyeolsi | 05368 | South Korea |
| Asan Medical Center /ID# 251312 | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Gangnam Severance Hospital /ID# 270030 | Seoul | Seoul Teugbyeolsi | 06273 | South Korea |
| Samsung Medical Center /ID# 259152 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245206 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 251314 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 238957 | Seoul | Seoul Teugbyeolsi | 07061 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 251325 | Seoul | Seoul Teugbyeolsi | 07061 | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309 | Seoul | Seoul Teugbyeolsi | 07345 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 262328 | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 270775 | Seoul | Seoul Teugbyeolsi | 07441 | South Korea |
| Ewha Womans University Seoul Hospital /ID# 251327 | Seoul | Seoul Teugbyeolsi | 07804 | South Korea |
| Ewha Womans University Medical Centre /ID# 270025 | Seoul | Seoul Teugbyeolsi | 07985 | South Korea |
| Korea University Guro Hospital /ID# 259141 | Seoul | Seoul Teugbyeolsi | 08308 | South Korea |
| HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956 | Seoul | Seoul Teugbyeolsi | 50612 | South Korea |
| Myungji Hospital /Id# 259148 | Goyang | 10475 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 248377 | Seoul | 03722 | South Korea |
| Duplicate_Inje University Seoul Paik Hospital /ID# 238994 | Seoul | 04551 | South Korea |
| Hallym University Kangdong Sacred Heart Hospital /ID# 251328 | Seoul | 05355 | South Korea |
| Hallym University Sacred Heart Hospital /ID# 269934 | Seoul | 14068 | South Korea |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D003876 | Dermatitis, Atopic |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
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