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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

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-26

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis (RA) Atopic Dermatitis (AD) Ankylosing Spondylitis (AS) Psoriatic Arthritis (PsA)

Keywords

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Rheumatoid Arthritis Atopic Dermatitis (AD) Ankylosing Spondylitis (AS) Psoriatic Arthritis (PsA) Upadacitinib RINVOQ

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants receiving Upadacitinib

Participants receiving Upadacitinib as prescribed by their physician per local label.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Inje University - Busan Paik Hospital /ID# 259143

Busan, Busan Gwang Yeogsi, South Korea

Site Status RECRUITING

Haeundae Bumin Hospital /ID# 238959

Busan, Busan Gwang Yeogsi, South Korea

Site Status RECRUITING

Inje University Haeundae Hospital /ID# 238949

Busan, Busan Gwang Yeogsi, South Korea

Site Status RECRUITING

Pusan National University Hospital /ID# 251315

Busan, Busan Gwang Yeogsi, South Korea

Site Status RECRUITING

Kosin University Gospel Hospital /ID# 239001

Busan, Busan Gwang Yeogsi, South Korea

Site Status RECRUITING

Dankook University Hospital /ID# 251307

Cheonan-si, Chungcheongnam-do, South Korea

Site Status RECRUITING

SoonChunHyang University Hospital Cheonan /ID# 248379

Cheonan-si, Chungcheongnam-do, South Korea

Site Status RECRUITING

SoonChunHyang University Hospital Cheonan /ID# 251302

Cheonan-si, Chungcheongnam-do, South Korea

Site Status RECRUITING

Kyungpook National University Hospital /ID# 251294

Junggu, Daegu Gwang Yeogsi, South Korea

Site Status RECRUITING

Kyungpook National University Hospital /ID# 251305

Junggu, Daegu Gwang Yeogsi, South Korea

Site Status RECRUITING

Chungnam National University Hospital /ID# 239000

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status RECRUITING

Chungnam National University Hospital /ID# 259097

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status RECRUITING

Daejeon Eulji Medical Center, Eulji University /ID# 251292

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status RECRUITING

Daejeon Eulji Medical Center, Eulji University /ID# 251293

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status RECRUITING

Konyang University Hospital /ID# 238951

Daejeon, Daejeon Gwang Yeogsi, South Korea

Site Status RECRUITING

Kangwon National University Hospital /ID# 248376

Chuncheon, Gang Weondo, South Korea

Site Status RECRUITING

Kangwon National University Hospital /ID# 259124

Chuncheon, Gang Weondo, South Korea

Site Status RECRUITING

Yonsei University-Wonju Severance Christian Hospital /ID# 239004

Wŏnju, Gang Weondo, South Korea

Site Status RECRUITING

Yonsei University-Wonju Severance Christian Hospital /ID# 239005

Wŏnju, Gang Weondo, South Korea

Site Status RECRUITING

Korea University Ansan Hospital /ID# 238992

Ansan-si, Gyeonggido, South Korea

Site Status RECRUITING

Korea University Ansan Hospital /ID# 251304

Ansan-si, Gyeonggido, South Korea

Site Status RECRUITING

Soon Chun Hyang University Hospital Bucheon /ID# 240935

Bucheon-si, Gyeonggido, South Korea

Site Status RECRUITING

Soon Chun Hyang University Hospital Bucheon /ID# 251321

Bucheon-si, Gyeonggido, South Korea

Site Status RECRUITING

The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142

Bucheon-si, Gyeonggido, South Korea

Site Status RECRUITING

The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270022

Bucheon-si, Gyeonggido, South Korea

Site Status RECRUITING

Chungang University Hospital /ID# 238993

Dongjak-gu, Gyeonggido, South Korea

Site Status RECRUITING

Chungang University Hospital /ID# 251322

Dongjak-gu, Gyeonggido, South Korea

Site Status RECRUITING

Inje University - Ilsan Paik Hospital /ID# 270021

Goyang-si, Gyeonggido, South Korea

Site Status RECRUITING

Hanyang University Guri Hospital /ID# 259173

Guri-si, Gyeonggido, South Korea

Site Status RECRUITING

Hanyang University Guri Hospital /ID# 259175

Guri-si, Gyeonggido, South Korea

Site Status RECRUITING

Chung-Ang University Gwangmyeong Hospital /Id# 259180

Gwangmyeong, Gyeonggido, South Korea

Site Status RECRUITING

Chung-Ang University Gwangmyeong Hospital /ID# 270825

Gwangmyeong, Gyeonggido, South Korea

Site Status RECRUITING

Hallym University Dongtan Sacred Heart Hospital /ID# 259177

Hwaseong, Gyeonggido, South Korea

Site Status RECRUITING

Gachon University Gil Medical Center /ID# 262757

Incheon, Gyeonggido, South Korea

Site Status RECRUITING

Catholic Kwandong University International St.Mary's Hospital /ID# 248380

Incheon, Gyeonggido, South Korea

Site Status RECRUITING

CHA Bundang Medical Center /ID# 251324

Seongnam, Gyeonggido, South Korea

Site Status RECRUITING

CHA Bundang Medical Center /ID# 267001

Seongnam, Gyeonggido, South Korea

Site Status RECRUITING

Bundang Jesaeng Hospital /ID# 238999

Seongnam, Gyeonggido, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital /ID# 248378

Seongnam-si, Gyeonggido, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital /ID# 259115

Seongnam-si, Gyeonggido, South Korea

Site Status RECRUITING

Hallym University Sacred Heart Hospital /ID# 259150

Seoul, Gyeonggido, South Korea

Site Status RECRUITING

The Catholic University Of Korea St. Vincent's Hospital /ID# 245207

Suwon, Gyeonggido, South Korea

Site Status RECRUITING

The Catholic University Of Korea St. Vincent's Hospital /ID# 259149

Suwon, Gyeonggido, South Korea

Site Status RECRUITING

Ajou University Hospital /ID# 243488

Suwon, Gyeonggido, South Korea

Site Status RECRUITING

Ajou University Hospital /ID# 244494

Suwon, Gyeonggido, South Korea

Site Status RECRUITING

Ajou University Hospital /ID# 259123

Suwon, Gyeonggido, South Korea

Site Status RECRUITING

Uijeongbu Eulji Medical Center - Eulji University /ID# 259144

Uijeongbu-si, Gyeonggido, South Korea

Site Status RECRUITING

Uijeongbu Eulji Medical Center - Eulji University /ID# 270781

Uijeongbu-si, Gyeonggido, South Korea

Site Status RECRUITING

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182

Uijeongbu-si, Gyeonggido, South Korea

Site Status RECRUITING

Yongin Severance Hospital /ID# 238948

Yŏngin, Gyeonggido, South Korea

Site Status RECRUITING

Yongin Severance Hospital /ID# 251311

Yŏngin, Gyeonggido, South Korea

Site Status RECRUITING

Daegu Catholic University Medical Center /ID# 238996

Daegu, Gyeongsangbuk-do, South Korea

Site Status RECRUITING

Keimyung University Dongsan Hospital /ID# 259172

Daegu, Gyeongsangbuk-do, South Korea

Site Status RECRUITING

Keimyung University Dongsan Hospital /ID# 269942

Daegu, Gyeongsangbuk-do, South Korea

Site Status RECRUITING

Samsung Changwon Hospital /ID# 239003

Changwon, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Gyeongsang National University Changwon Hospital /ID# 269931

Changwon, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Changwon Fatima Hospital /ID# 238958

Changwon-si, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Gyeongsang National University Hospital /ID# 267003

Jinju, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Dong-A University Medical Center /ID# 269937

Pusan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Pusan National University Yangsan Hospital /ID# 239002

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Pusan National University Yangsan Hospital /ID# 259120

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 240934

Incheon, Incheon Gwang Yeogsi, South Korea

Site Status RECRUITING

The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 251306

Incheon, Incheon Gwang Yeogsi, South Korea

Site Status RECRUITING

The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 269811

Incheon, Incheon Gwang Yeogsi, South Korea

Site Status RECRUITING

Inha University Hospital /ID# 251317

Incheon, Incheon Gwang Yeogsi, South Korea

Site Status RECRUITING

Design Hospital /ID# 262327

Jeollabuk-do, Jeonrabugdo, South Korea

Site Status RECRUITING

Jeonbuk National University Hospital /ID# 259140

Jeonju, Jeonrabugdo, South Korea

Site Status RECRUITING

Chonnam National University Hospital /ID# 251326

Donggu, Jeonranamdo, South Korea

Site Status RECRUITING

Chosun University Hospital /ID# 259119

Gwangju, Jeonranamdo, South Korea

Site Status RECRUITING

Chungbuk National University Hospital /ID# 238997

Cheongju-si, North Chungcheong, South Korea

Site Status RECRUITING

Chungbuk National University Hospital /ID# 262334

Cheongju-si, North Chungcheong, South Korea

Site Status RECRUITING

Dr. Park's Internal Medicine Clinic /ID# 238995

Chungbuk, North Chungcheong, South Korea

Site Status RECRUITING

Konkuk University Chungju Hospital /ID# 240936

Chungju, North Chungcheong, South Korea

Site Status RECRUITING

Sejong Chungnam National University Hospital /ID# 238952

Sejong-si, Sejong-si, South Korea

Site Status RECRUITING

Sejong Chungnam National University Hospital /ID# 259216

Sejong-si, Sejong-si, South Korea

Site Status RECRUITING