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

December 6, 2023 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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3600

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 48059
        • Recruiting
        • Haeundae Bumin Hospital /ID# 238959
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Hospital /ID# 238949
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital /ID# 251315
      • Busan, Korea, Republic of, 49267
        • Recruiting
        • Kosin University Gospel Hospital /ID# 239001
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje University Busan Paik Hospital /ID# 259143
      • Changwon, Korea, Republic of, 51353
        • Recruiting
        • Samsung Changwon Hospital /ID# 239003
      • Cheonan, Korea, Republic of, 31116
        • Recruiting
        • Dankook University Hospital /ID# 251307
      • Cheongju, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital /ID# 238997
      • Cheongju, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital /ID# 262334
      • Chungbuk, Korea, Republic of, 28641
        • Recruiting
        • Dr. Park's Internal Medicine Clinic /ID# 238995
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital /ID# 251294
      • Daegu, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital /ID# 251305
      • Daegu, Korea, Republic of, 42472
        • Recruiting
        • Daegu Catholic University Medical Center /ID# 238996
      • Daegu, Korea, Republic of, 41931
        • Recruiting
        • Keimyung University Dongsan Medical Center /ID# 259172
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Chungnam National University Hospital /ID# 239000
      • Daejeon, Korea, Republic of, 35233
        • Recruiting
        • Daejeon Eulji Medical Center, Eulji University /ID# 251292
      • Daejeon, Korea, Republic of, 35233
        • Recruiting
        • Daejeon Eulji Medical Center, Eulji University /ID# 251293
      • Daejeon, Korea, Republic of, 35365
        • Recruiting
        • Konyang University Hospital /ID# 238951
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Chungnam National University Hospital /ID# 259097
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital /ID# 251326
      • Gwangju, Korea, Republic of, 61453
        • Recruiting
        • Chosun University Hospital /ID# 259119
      • Gwangmyeong, Korea, Republic of, 04401
        • Recruiting
        • Chung-Ang University Gwangmyeong Hospital /Id# 259180
      • Incheon, Korea, Republic of, 21431
        • Recruiting
        • The Catholic University of Korea Incheon St.Mary's Hospital /ID# 240934
      • Incheon, Korea, Republic of, 21431
        • Recruiting
        • The Catholic University of Korea Incheon St.Mary's Hospital /ID# 251306
      • Incheon, Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital /ID# 251317
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center /ID# 262757
      • Jeollabuk-do, Korea, Republic of, 54910
        • Recruiting
        • Design Hospital /ID# 262327
      • Jeonju, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital /ID# 259140
      • Kangwondo, Korea, Republic of, 24289
        • Recruiting
        • Kangwon National University Hospital /ID# 248376
      • Kangwondo, Korea, Republic of, 24289
        • Recruiting
        • Kangwon National University Hospital /ID# 259124
      • Sejong-si, Korea, Republic of, 30099
        • Recruiting
        • Chungnam National University Sejong Hospital /ID# 238952
      • Sejong-si, Korea, Republic of, 30099
        • Recruiting
        • Chungnam National University Sejong Hospital /ID# 259216
      • Seoul, Korea, Republic of, 01755
        • Recruiting
        • Inje University Sanggye Paik Hospital /ID# 251316
      • Seoul, Korea, Republic of, 02053
        • Recruiting
        • Seoul Medical Center /ID# 251310
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital /ID# 245209
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital /ID# 251319
      • Seoul, Korea, Republic of, 04551
        • Completed
        • Inje University Seoul Paik Hospital /ID# 238994
      • Seoul, Korea, Republic of, 04564
        • Recruiting
        • National Medical Center /ID# 251303
      • Seoul, Korea, Republic of, 05119
        • Recruiting
        • Rheuma Internal Clinic /ID# 238998
      • Seoul, Korea, Republic of, 05257
        • Recruiting
        • Asan Bone Internal Medicine /ID# 238991
      • Seoul, Korea, Republic of, 05355
        • Recruiting
        • Kangdong Sacred Heart Hospital /ID# 251328
      • Seoul, Korea, Republic of, 05368
        • Recruiting
        • VHS(Veterans Health Service) Medical Center /ID# 251323
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center /ID# 251312
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 245206
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 251314
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hostipal /ID# 238993
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hostipal /ID# 251322
      • Seoul, Korea, Republic of, 07345
        • Recruiting
        • The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309
      • Seoul, Korea, Republic of, 07804
        • Recruiting
        • Ewha Womans University Seoul Hospital /ID# 251327
      • Seoul, Korea, Republic of, 50612
        • Recruiting
        • HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956
      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • Kyung Hee University Medical Center /ID# 259117
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System /ID# 259178
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center /ID# 259152
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital /ID# 259141
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital /ID# 262333
      • Seoul, Korea, Republic of, 07441
        • Recruiting
        • Hallym University Kangnam Sacred Heart Hospital /ID# 262328
      • Wonju, Korea, Republic of, 26426
        • Recruiting
        • Wonju Severance Christian Hospital /ID# 239004
      • Wonju, Korea, Republic of, 26426
        • Recruiting
        • Wonju Severance Christian Hospital /ID# 239005
      • Yongin, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital /ID# 238948
      • Yongin, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital /ID# 251311
      • Yongsan-gu, Korea, Republic of, 04401
        • Recruiting
        • SoonChunHyang University Hospital /ID# 259179
      • 고양시, Korea, Republic of, 10475
        • Recruiting
        • Myungji Hospital /Id# 259148
      • 부천시, Korea, Republic of, 14584
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon /ID# 240935
      • 서구, Korea, Republic of, 22711
        • Recruiting
        • Catholic Kwandong University International St. Mary's Hospital /ID# 248380
      • 의정부시, Korea, Republic of, 11759
        • Recruiting
        • Euijeonbu Eulji Medical Center, Eulji University /ID# 259144
      • 충주시, Korea, Republic of, 27376
        • Recruiting
        • Konkuk University Chungju Hospital /ID# 240936
    • Chungcheongnamdo
      • Cheonan-si, Chungcheongnamdo, Korea, Republic of, 31151
        • Recruiting
        • SoonChunHyang University CheonAn Hospital /ID# 248379
      • Cheonan-si, Chungcheongnamdo, Korea, Republic of, 31151
        • Recruiting
        • SoonChunHyang University CheonAn Hospital /ID# 251302
    • Gyeonggido
      • Ansan, Gyeonggido, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital /ID# 238992
      • Ansan, Gyeonggido, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital /ID# 251304
      • Anyang, Gyeonggido, Korea, Republic of, 14068
        • Recruiting
        • Hallym University Sacred Heart Hospital /ID# 259150
      • Bucheon, Gyeonggido, Korea, Republic of, 14584
        • Recruiting
        • Soonchunhyang University Hospital Bucheon /ID# 251321
      • Bucheon, Gyeonggido, Korea, Republic of, 14647
        • Recruiting
        • The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Recruiting
        • Hanyang University Gurihospital /ID# 259173
      • Guri, Gyeonggido, Korea, Republic of, 11923
        • Recruiting
        • Hanyang University Gurihospital /ID# 259175
      • Hwaseong, Gyeonggido, Korea, Republic of, 18450
        • Recruiting
        • Dongtan Sacred Heart Hospital /ID# 259177
      • Seongnam, Gyeonggido, Korea, Republic of, 13590
        • Recruiting
        • Bundang Jesaeng hospital /ID# 238999
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital /ID# 248378
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital /ID# 259115
      • Seongnam si, Gyeonggido, Korea, Republic of, 13496
        • Recruiting
        • CHA University Bundang Medical Center /ID# 251324
      • Suwon, Gyeonggido, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University of Korea, ST. Vincent's Hospital /ID# 245207
      • Suwon, Gyeonggido, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital /ID# 243488
      • Suwon, Gyeonggido, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital /ID# 244494
      • Suwon, Gyeonggido, Korea, Republic of, 16247
        • Recruiting
        • The Catholic University of Korea, ST. Vincent's Hospital /ID# 259149
      • Suwon, Gyeonggido, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital /ID# 259123
      • Uijeongbu, Gyeonggido, Korea, Republic of, 11765
        • Recruiting
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182
    • Gyeongsangnamdo
      • Changwon, Gyeongsangnamdo, Korea, Republic of, 51394
        • Recruiting
        • Changwon Fatima Hospital /ID# 238958
      • Yangsan-si, Gyeongsangnamdo, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital /ID# 239002
      • Yangsan-si, Gyeongsangnamdo, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital /ID# 259120
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Seoul Hospital /ID# 238640
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital /ID# 238955
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital /ID# 251308
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 248377
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
        • Recruiting
        • Hanyang University Seoul Hospital /ID# 251320
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
        • Recruiting
        • KonKuk University Medical Center /ID# 245208
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07061
        • Recruiting
        • SMG-SNU Boramae Medical Center /ID# 238957
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07061
        • Recruiting
        • SMG-SNU Boramae Medical Center /ID# 251325

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 (Estimated)

December 31, 2025

Study Completion (Estimated)

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 (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

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.

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