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

Recruiting

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2021-01-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

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.

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Exclusion Criteria

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

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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.

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