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

February 10, 2026 updated by: AbbVie

Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib in Korean Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Goyang, South Korea, 10475
        • Myungji Hospital /Id# 259148
      • Seoul, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 248377
      • Seoul, South Korea, 04551
        • Duplicate_Inje University Seoul Paik Hospital /ID# 238994
      • Seoul, South Korea, 05355
        • Hallym University Kangdong Sacred Heart Hospital /ID# 251328
      • Seoul, South Korea, 14068
        • Hallym University Sacred Heart Hospital /ID# 269934
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 47392
        • Inje University - Busan Paik Hospital /ID# 259143
      • Busan, Busan Gwang Yeogsi, South Korea, 48059
        • Haeundae Bumin Hospital /ID# 238959
      • Busan, Busan Gwang Yeogsi, South Korea, 48108
        • Inje University Haeundae Hospital /ID# 238949
      • Busan, Busan Gwang Yeogsi, South Korea, 49201
        • Dong-A University Medical Center /ID# 269937
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Pusan National University Hospital /ID# 251315
      • Busan, Busan Gwang Yeogsi, South Korea, 49267
        • Kosin University Gospel Hospital /ID# 239001
    • Chungcheongnam-do
      • Cheonan-si, Chungcheongnam-do, South Korea, 31116
        • Dankook University Hospital /ID# 251307
      • Cheonan-si, Chungcheongnam-do, South Korea, 31151
        • SoonChunHyang University Hospital Cheonan /ID# 248379
      • Cheonan-si, Chungcheongnam-do, South Korea, 31151
        • SoonChunHyang University Hospital Cheonan /ID# 251302
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, South Korea, 41944
        • Kyungpook National University Hospital /ID# 251294
      • Daegu, Daegu Gwang Yeogsi, South Korea, 41944
        • Kyungpook National University Hospital /ID# 251305
    • Daejeon Gwang Yeogsi
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35015
        • Chungnam National University Hospital /ID# 239000
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35015
        • Chungnam National University Hospital /ID# 259097
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35233
        • Daejeon Eulji Medical Center, Eulji University /ID# 251292
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35233
        • Daejeon Eulji Medical Center, Eulji University /ID# 251293
      • Daejeon, Daejeon Gwang Yeogsi, South Korea, 35365
        • Konyang University Hospital /ID# 238951
    • Gang Weondo
      • Chuncheon, Gang Weondo, South Korea, 24289
        • Kangwon National University Hospital /ID# 248376
      • Chuncheon, Gang Weondo, South Korea, 24289
        • Kangwon National University Hospital /ID# 259124
      • Wŏnju, Gang Weondo, South Korea, 26426
        • Yonsei University-Wonju Severance Christian Hospital /ID# 239004
      • Wŏnju, Gang Weondo, South Korea, 26426
        • Yonsei University-Wonju Severance Christian Hospital /ID# 239005
    • Gyeonggido
      • Ansan-si, Gyeonggido, South Korea, 15355
        • Korea University Ansan Hospital /ID# 238992
      • Ansan-si, Gyeonggido, South Korea, 15355
        • Korea University Ansan Hospital /ID# 251304
      • Bucheon-si, Gyeonggido, South Korea, 14584
        • Soon Chun Hyang University Hospital Bucheon /ID# 240935
      • Bucheon-si, Gyeonggido, South Korea, 14584
        • Soon Chun Hyang University Hospital Bucheon /ID# 251321
      • Bucheon-si, Gyeonggido, South Korea, 14647
        • The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 270022
      • Bucheon-si, Gyeonggido, South Korea, 14647
        • The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142
      • Goyang, Gyeonggido, South Korea, 10380
        • Inje University - Ilsan Paik Hospital /ID# 270021
      • Guri-si, Gyeonggido, South Korea, 11923
        • Hanyang University Guri Hospital /ID# 259173
      • Guri-si, Gyeonggido, South Korea, 11923
        • Hanyang University Guri Hospital /ID# 259175
      • Gwangmyeong, Gyeonggido, South Korea, 04401
        • Chung-Ang University Gwangmyeong Hospital /Id# 259180
      • Gwangmyeong, Gyeonggido, South Korea, 14353
        • Chung-Ang University Gwangmyeong Hospital /ID# 270825
      • Hwaseong, Gyeonggido, South Korea, 18450
        • Hallym University Dongtan Sacred Heart Hospital /ID# 259177
      • Incheon, Gyeonggido, South Korea, 21565
        • Gachon University Gil Medical Center /ID# 262757
      • Incheon, Gyeonggido, South Korea, 22711
        • Catholic Kwandong University International St.Mary's Hospital /ID# 248380
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 251324
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 267001
      • Seongnam, Gyeonggido, South Korea, 13590
        • Bundang Jesaeng Hospital /ID# 238999
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 248378
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • Seoul National University Bundang Hospital /ID# 259115
      • Seoul, Gyeonggido, South Korea, 14067
        • Hallym University Sacred Heart Hospital /ID# 259150
      • Suwon, Gyeonggido, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital /ID# 245207
      • Suwon, Gyeonggido, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital /ID# 259149
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital /ID# 243488
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital /ID# 244494
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital /ID# 259123
      • Uijeongbu-si, Gyeonggido, South Korea, 11759
        • Uijeongbu Eulji Medical Center - Eulji University /ID# 259144
      • Uijeongbu-si, Gyeonggido, South Korea, 11759
        • Uijeongbu Eulji Medical Center - Eulji University /ID# 270781
      • Uijeongbu-si, Gyeonggido, South Korea, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182
      • Yŏngin, Gyeonggido, South Korea, 16995
        • Yongin Severance Hospital /ID# 238948
      • Yŏngin, Gyeonggido, South Korea, 16995
        • Yongin Severance Hospital /ID# 251311
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42472
        • Daegu Catholic University Medical Center /ID# 238996
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 259172
      • Daegu, Gyeongsangbuk-do, South Korea, 42601
        • Keimyung University Dongsan Hospital /ID# 269942
    • Gyeongsangnam-do
      • Changwon, Gyeongsangnam-do, South Korea, 51353
        • Samsung Changwon Hospital /ID# 239003
      • Changwon-si, Gyeongsangnam-do, South Korea, 51394
        • Changwon Fatima Hospital /ID# 238958
      • Changwon-si, Gyeongsangnam-do, South Korea, 51472
        • Gyeongsang National University Changwon Hospital /ID# 269931
      • Jinju, Gyeongsangnam-do, South Korea, 52727
        • Gyeongsang National University Hospital /ID# 267003
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Pusan National University Yangsan Hospital /ID# 239002
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Pusan National University Yangsan Hospital /ID# 259120
    • Incheon Gwang Yeogsi
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 240934
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 251306
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 269811
      • Incheon, Incheon Gwang Yeogsi, South Korea, 21565
        • Inha University Hospital /ID# 251317
    • Jeonrabugdo
      • Jeollabuk-do, Jeonrabugdo, South Korea, 54910
        • Design Hospital /ID# 262327
      • Jeonju, Jeonrabugdo, South Korea, 54907
        • Jeonbuk National University Hospital /ID# 259140
    • Jeonranamdo
      • Gwangju, Jeonranamdo, South Korea, 61453
        • Chosun University Hospital /ID# 259119
      • Gwangju, Jeonranamdo, South Korea, 61469
        • Chonnam National University Hospital /ID# 251326
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital /ID# 238997
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital /ID# 262334
      • Chungbuk, North Chungcheong, South Korea, 28641
        • Dr. Park's Internal Medicine Clinic /ID# 238995
      • Chungju, North Chungcheong, South Korea, 27376
        • Konkuk University Chungju Hospital /ID# 240936
    • Sejong-si
      • Sejong-si, Sejong-si, South Korea, 30099
        • Sejong Chungnam National University Hospital /ID# 238952
      • Sejong-si, Sejong-si, South Korea, 30099
        • Sejong Chungnam National University Hospital /ID# 259216
    • Seoul Teugbyeolsi
      • Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
        • Chungang University Hospital /ID# 238993
      • Dongjak-gu, Seoul Teugbyeolsi, South Korea, 06973
        • Chungang University Hospital /ID# 251322
      • Seoul, Seoul Teugbyeolsi, South Korea, 01757
        • Inje University Sanggye Paik Hospital /ID# 251316
      • Seoul, Seoul Teugbyeolsi, South Korea, 01830
        • Nowon Eulji Medical Center, Eulji University /ID# 259139
      • Seoul, Seoul Teugbyeolsi, South Korea, 02053
        • Seoul Medical Center /ID# 251310
      • Seoul, Seoul Teugbyeolsi, South Korea, 02447
        • Kyung Hee University Hospital /ID# 259117
      • Seoul, Seoul Teugbyeolsi, South Korea, 02447
        • Kyung Hee University Hospital /ID# 270182
      • Seoul, Seoul Teugbyeolsi, South Korea, 02841
        • Korea University Anam Hospital /ID# 262333
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 245209
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 251319
      • Seoul, Seoul Teugbyeolsi, South Korea, 03181
        • Kangbuk Samsung Hospital /ID# 238955
      • Seoul, Seoul Teugbyeolsi, South Korea, 03181
        • Kangbuk Samsung Hospital /ID# 251308
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 259178
      • Seoul, Seoul Teugbyeolsi, South Korea, 04401
        • SoonChunHyang University Seoul Hospital /ID# 259179
      • Seoul, Seoul Teugbyeolsi, South Korea, 04401
        • SoonChunHyang University Seoul Hospital /ID# 269940
      • Seoul, Seoul Teugbyeolsi, South Korea, 04564
        • National Medical Center /ID# 251303
      • Seoul, Seoul Teugbyeolsi, South Korea, 04763
        • Hanyang University Seoul Hospital /ID# 238640
      • Seoul, Seoul Teugbyeolsi, South Korea, 04763
        • Hanyang University Seoul Hospital /ID# 251320
      • Seoul, Seoul Teugbyeolsi, South Korea, 05030
        • Konkuk University Medical Center /ID# 245208
      • Seoul, Seoul Teugbyeolsi, South Korea, 05119
        • Rheuma Internal Clinic /ID# 238998
      • Seoul, Seoul Teugbyeolsi, South Korea, 05257
        • Asan Bone Internal Medicine /ID# 238991
      • Seoul, Seoul Teugbyeolsi, South Korea, 05278
        • Kyung Hee University Hospital at Gangdong /ID# 267000
      • Seoul, Seoul Teugbyeolsi, South Korea, 05278
        • Kyung Hee University Hospital at Gangdong /ID# 267004
      • Seoul, Seoul Teugbyeolsi, South Korea, 05368
        • VHS(Veterans Health Service) Medical Center /ID# 251323
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 251312
      • Seoul, Seoul Teugbyeolsi, South Korea, 06273
        • Gangnam Severance Hospital /ID# 270030
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 259152
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245206
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 251314
      • Seoul, Seoul Teugbyeolsi, South Korea, 07061
        • SMG-SNU Boramae Medical Center /ID# 238957
      • Seoul, Seoul Teugbyeolsi, South Korea, 07061
        • SMG-SNU Boramae Medical Center /ID# 251325
      • Seoul, Seoul Teugbyeolsi, South Korea, 07345
        • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 262328
      • Seoul, Seoul Teugbyeolsi, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 270775
      • Seoul, Seoul Teugbyeolsi, South Korea, 07804
        • Ewha Womans University Seoul Hospital /ID# 251327
      • Seoul, Seoul Teugbyeolsi, South Korea, 07985
        • Ewha Womans University Medical Centre /ID# 270025
      • Seoul, Seoul Teugbyeolsi, South Korea, 08308
        • Korea University Guro Hospital /ID# 259141
      • Seoul, Seoul Teugbyeolsi, South Korea, 50612
        • HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events
Time Frame: 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.
Up to approximately 6 years
Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only)
Time Frame: Up to 24 weeks
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)
Time Frame: Up to 16 weeks
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)
Time Frame: Up to 12 weeks
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)
Time Frame: 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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis (RA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe