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Rheumatoid Arthritis (RA)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

An observational study of Rheumatoid Arthritis (RA) and Atopic Dermatitis (AD), run by AbbVie at 116 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
How many people
2,369 participants
Where
116 sitesSouth Korea
Study dates
26 Jan 2021to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

116 sites in 1 country.

116 sites in 1 country

South Korea116 sites

  • Korea University Ansan Hospital /ID# 238992

    Ansan-si, Gyeonggido, 15355

  • Korea University Ansan Hospital /ID# 251304

    Ansan-si, Gyeonggido, 15355

  • Soon Chun Hyang University Hospital Bucheon /ID# 240935

    Bucheon-si, Gyeonggido, 14584

  • Soon Chun Hyang University Hospital Bucheon /ID# 251321

    Bucheon-si, Gyeonggido, 14584

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

    Bucheon-si, Gyeonggido, 14647

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

    Bucheon-si, Gyeonggido, 14647

  • Inje University - Busan Paik Hospital /ID# 259143

    Busan, Busan Gwang Yeogsi, 47392

  • Haeundae Bumin Hospital /ID# 238959

    Busan, Busan Gwang Yeogsi, 48059

  • Inje University Haeundae Hospital /ID# 238949

    Busan, Busan Gwang Yeogsi, 48108

  • Dong-A University Medical Center /ID# 269937

    Busan, Busan Gwang Yeogsi, 49201

  • Pusan National University Hospital /ID# 251315

    Busan, Busan Gwang Yeogsi, 49241

  • Kosin University Gospel Hospital /ID# 239001

    Busan, Busan Gwang Yeogsi, 49267

  • Samsung Changwon Hospital /ID# 239003

    Changwon, Gyeongsangnam-do, 51353

  • Changwon Fatima Hospital /ID# 238958

    Changwon-si, Gyeongsangnam-do, 51394

  • Gyeongsang National University Changwon Hospital /ID# 269931

    Changwon-si, Gyeongsangnam-do, 51472

  • Dankook University Hospital /ID# 251307

    Cheonan-si, Chungcheongnam-do, 31116

  • SoonChunHyang University Hospital Cheonan /ID# 248379

    Cheonan-si, Chungcheongnam-do, 31151

  • SoonChunHyang University Hospital Cheonan /ID# 251302

    Cheonan-si, Chungcheongnam-do, 31151

  • Chungbuk National University Hospital /ID# 238997

    Cheongju-si, North Chungcheong, 28644

  • Chungbuk National University Hospital /ID# 262334

    Cheongju-si, North Chungcheong, 28644

  • Kangwon National University Hospital /ID# 248376

    Chuncheon, Gang Weondo, 24289

  • Kangwon National University Hospital /ID# 259124

    Chuncheon, Gang Weondo, 24289

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

    Chungbuk, North Chungcheong, 28641

  • Konkuk University Chungju Hospital /ID# 240936

    Chungju, North Chungcheong, 27376

  • Kyungpook National University Hospital /ID# 251294

    Daegu, Daegu Gwang Yeogsi, 41944

  • Kyungpook National University Hospital /ID# 251305

    Daegu, Daegu Gwang Yeogsi, 41944

  • Daegu Catholic University Medical Center /ID# 238996

    Daegu, Gyeongsangbuk-do, 42472

  • Keimyung University Dongsan Hospital /ID# 259172

    Daegu, Gyeongsangbuk-do, 42601

  • Keimyung University Dongsan Hospital /ID# 269942

    Daegu, Gyeongsangbuk-do, 42601

  • Chungnam National University Hospital /ID# 239000

    Daejeon, Daejeon Gwang Yeogsi, 35015

  • Chungnam National University Hospital /ID# 259097

    Daejeon, Daejeon Gwang Yeogsi, 35015

  • Daejeon Eulji Medical Center, Eulji University /ID# 251292

    Daejeon, Daejeon Gwang Yeogsi, 35233

  • Daejeon Eulji Medical Center, Eulji University /ID# 251293

    Daejeon, Daejeon Gwang Yeogsi, 35233

  • Konyang University Hospital /ID# 238951

    Daejeon, Daejeon Gwang Yeogsi, 35365

  • Chungang University Hospital /ID# 238993

    Dongjak-gu, Seoul Teugbyeolsi, 06973

  • Chungang University Hospital /ID# 251322

    Dongjak-gu, Seoul Teugbyeolsi, 06973

  • Inje University - Ilsan Paik Hospital /ID# 270021

    Goyang, Gyeonggido, 10380

  • Myungji Hospital /Id# 259148

    Goyang, 10475

  • Hanyang University Guri Hospital /ID# 259173

    Guri-si, Gyeonggido, 11923

  • Hanyang University Guri Hospital /ID# 259175

    Guri-si, Gyeonggido, 11923

  • Chosun University Hospital /ID# 259119

    Gwangju, Jeonranamdo, 61453

  • Chonnam National University Hospital /ID# 251326

    Gwangju, Jeonranamdo, 61469

  • Chung-Ang University Gwangmyeong Hospital /Id# 259180

    Gwangmyeong, Gyeonggido, 04401

  • Chung-Ang University Gwangmyeong Hospital /ID# 270825

    Gwangmyeong, Gyeonggido, 14353

  • Hallym University Dongtan Sacred Heart Hospital /ID# 259177

    Hwaseong, Gyeonggido, 18450

  • Gachon University Gil Medical Center /ID# 262757

    Incheon, Gyeonggido, 21565

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

    Incheon, Gyeonggido, 22711

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

    Incheon, Incheon Gwang Yeogsi, 21431

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

    Incheon, Incheon Gwang Yeogsi, 21431

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

    Incheon, Incheon Gwang Yeogsi, 21431

  • Inha University Hospital /ID# 251317

    Incheon, Incheon Gwang Yeogsi, 21565

  • Design Hospital /ID# 262327

    Jeollabuk-do, Jeonrabugdo, 54910

  • Jeonbuk National University Hospital /ID# 259140

    Jeonju, Jeonrabugdo, 54907

  • Gyeongsang National University Hospital /ID# 267003

    Jinju, Gyeongsangnam-do, 52727

  • Sejong Chungnam National University Hospital /ID# 238952

    Sejong-si, Sejong-si, 30099

  • Sejong Chungnam National University Hospital /ID# 259216

    Sejong-si, Sejong-si, 30099

  • CHA Bundang Medical Center /ID# 251324

    Seongnam, Gyeonggido, 13496

  • CHA Bundang Medical Center /ID# 267001

    Seongnam, Gyeonggido, 13496

  • Bundang Jesaeng Hospital /ID# 238999

    Seongnam, Gyeonggido, 13590

  • Seoul National University Bundang Hospital /ID# 248378

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Bundang Hospital /ID# 259115

    Seongnam-si, Gyeonggido, 13620

  • Hallym University Sacred Heart Hospital /ID# 259150

    Seoul, Gyeonggido, 14067

  • Inje University Sanggye Paik Hospital /ID# 251316

    Seoul, Seoul Teugbyeolsi, 01757

  • Nowon Eulji Medical Center, Eulji University /ID# 259139

    Seoul, Seoul Teugbyeolsi, 01830

  • Seoul Medical Center /ID# 251310

    Seoul, Seoul Teugbyeolsi, 02053

  • Kyung Hee University Hospital /ID# 259117

    Seoul, Seoul Teugbyeolsi, 02447

  • Kyung Hee University Hospital /ID# 270182

    Seoul, Seoul Teugbyeolsi, 02447

  • Korea University Anam Hospital /ID# 262333

    Seoul, Seoul Teugbyeolsi, 02841

  • Seoul National University Hospital /ID# 245209

    Seoul, Seoul Teugbyeolsi, 03080

  • Seoul National University Hospital /ID# 251319

    Seoul, Seoul Teugbyeolsi, 03080

  • Kangbuk Samsung Hospital /ID# 238955

    Seoul, Seoul Teugbyeolsi, 03181

  • Kangbuk Samsung Hospital /ID# 251308

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 259178

    Seoul, Seoul Teugbyeolsi, 03722

  • SoonChunHyang University Seoul Hospital /ID# 259179

    Seoul, Seoul Teugbyeolsi, 04401

  • SoonChunHyang University Seoul Hospital /ID# 269940

    Seoul, Seoul Teugbyeolsi, 04401

  • National Medical Center /ID# 251303

    Seoul, Seoul Teugbyeolsi, 04564

  • Hanyang University Seoul Hospital /ID# 238640

    Seoul, Seoul Teugbyeolsi, 04763

  • Hanyang University Seoul Hospital /ID# 251320

    Seoul, Seoul Teugbyeolsi, 04763

  • Konkuk University Medical Center /ID# 245208

    Seoul, Seoul Teugbyeolsi, 05030

  • Rheuma Internal Clinic /ID# 238998

    Seoul, Seoul Teugbyeolsi, 05119

  • Asan Bone Internal Medicine /ID# 238991

    Seoul, Seoul Teugbyeolsi, 05257

  • Kyung Hee University Hospital at Gangdong /ID# 267000

    Seoul, Seoul Teugbyeolsi, 05278

  • Kyung Hee University Hospital at Gangdong /ID# 267004

    Seoul, Seoul Teugbyeolsi, 05278

  • VHS(Veterans Health Service) Medical Center /ID# 251323

    Seoul, Seoul Teugbyeolsi, 05368

  • Asan Medical Center /ID# 251312

    Seoul, Seoul Teugbyeolsi, 05505

  • Gangnam Severance Hospital /ID# 270030

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center /ID# 259152

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245206

    Seoul, Seoul Teugbyeolsi, 06591

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 251314

    Seoul, Seoul Teugbyeolsi, 06591

  • SMG-SNU Boramae Medical Center /ID# 238957

    Seoul, Seoul Teugbyeolsi, 07061

  • SMG-SNU Boramae Medical Center /ID# 251325

    Seoul, Seoul Teugbyeolsi, 07061

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309

    Seoul, Seoul Teugbyeolsi, 07345

  • Hallym University Kangnam Sacred Heart Hospital /ID# 262328

    Seoul, Seoul Teugbyeolsi, 07441

  • Hallym University Kangnam Sacred Heart Hospital /ID# 270775

    Seoul, Seoul Teugbyeolsi, 07441

  • Ewha Womans University Seoul Hospital /ID# 251327

    Seoul, Seoul Teugbyeolsi, 07804

  • Ewha Womans University Medical Centre /ID# 270025

    Seoul, Seoul Teugbyeolsi, 07985

  • Korea University Guro Hospital /ID# 259141

    Seoul, Seoul Teugbyeolsi, 08308

  • HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956

    Seoul, Seoul Teugbyeolsi, 50612

  • Yonsei University Health System Severance Hospital /ID# 248377

    Seoul, 03722

  • Duplicate_Inje University Seoul Paik Hospital /ID# 238994

    Seoul, 04551

  • Hallym University Kangdong Sacred Heart Hospital /ID# 251328

    Seoul, 05355

  • Hallym University Sacred Heart Hospital /ID# 269934

    Seoul, 14068

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

    Suwon, Gyeonggido, 16247

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

    Suwon, Gyeonggido, 16247

  • Ajou University Hospital /ID# 243488

    Suwon, Gyeonggido, 16499

  • Ajou University Hospital /ID# 244494

    Suwon, Gyeonggido, 16499

  • Ajou University Hospital /ID# 259123

    Suwon, Gyeonggido, 16499

  • Uijeongbu Eulji Medical Center - Eulji University /ID# 259144

    Uijeongbu-si, Gyeonggido, 11759

  • Uijeongbu Eulji Medical Center - Eulji University /ID# 270781

    Uijeongbu-si, Gyeonggido, 11759

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

    Uijeongbu-si, Gyeonggido, 11765

  • Yonsei University-Wonju Severance Christian Hospital /ID# 239004

    Wŏnju, Gang Weondo, 26426

  • Yonsei University-Wonju Severance Christian Hospital /ID# 239005

    Wŏnju, Gang Weondo, 26426

  • Pusan National University Yangsan Hospital /ID# 239002

    Yangsan, Gyeongsangnam-do, 50612

  • Pusan National University Yangsan Hospital /ID# 259120

    Yangsan, Gyeongsangnam-do, 50612

  • Yongin Severance Hospital /ID# 238948

    Yŏngin, Gyeonggido, 16995

  • Yongin Severance Hospital /ID# 251311

    Yŏngin, Gyeonggido, 16995

Other trials in South Korea

About this study

Official title: 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.

Read more

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.

Keywords
Rheumatoid Arthritis, Atopic Dermatitis (AD), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Upadacitinib, RINVOQ
Medical subject headings
Arthritis, Rheumatoid, Dermatitis, Atopic, Spondylitis, Ankylosing, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04541810
Study groupRoleWhat they receive
Participants receiving UpadacitinibParticipants receiving Upadacitinib as prescribed by their physician per local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 6 years

  2. 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.

    Measured: Up to 24 weeks

  3. 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.

    Measured: Up to 16 weeks

  4. 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.

    Measured: Up to 12 weeks

  5. 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.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start26 Jan 2021
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04541810
Sponsor's protocol ID
P20-319
Status last verified
Feb 2026
First submitted
31 Aug 2020
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis (RA) and Atopic Dermatitis (AD), run by AbbVie at 116 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (time frame: Up to approximately 6 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04541810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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