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

NCT04541810 | Completed

• 1 other identifier: P20-319
• Study Type: observational
• Target: 2,369
• Locations: 1 country
• Sites: 116

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to approximately 6 years

• 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.

  Up to 24 weeks

• 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.

  Up to 16 weeks

• 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.

  Up to 12 weeks

• 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.

  Up to 12 weeks

Study Arms (1)

Participants receiving Upadacitinib

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (116)

Inje University - Busan Paik Hospital /ID# 259143

Busan, Busan Gwang Yeogsi, 47392, South Korea

Location

Haeundae Bumin Hospital /ID# 238959

Busan, Busan Gwang Yeogsi, 48059, South Korea

Location

Inje University Haeundae Hospital /ID# 238949

Busan, Busan Gwang Yeogsi, 48108, South Korea

Location

Dong-A University Medical Center /ID# 269937

Busan, Busan Gwang Yeogsi, 49201, South Korea

Location

Pusan National University Hospital /ID# 251315

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Kosin University Gospel Hospital /ID# 239001

Busan, Busan Gwang Yeogsi, 49267, South Korea

Location

Dankook University Hospital /ID# 251307

Cheonan-si, Chungcheongnam-do, 31116, South Korea

Location

SoonChunHyang University Hospital Cheonan /ID# 248379

Cheonan-si, Chungcheongnam-do, 31151, South Korea

Location

SoonChunHyang University Hospital Cheonan /ID# 251302

Cheonan-si, Chungcheongnam-do, 31151, South Korea

Location

Kyungpook National University Hospital /ID# 251294

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Kyungpook National University Hospital /ID# 251305

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Chungnam National University Hospital /ID# 239000

Daejeon, Daejeon Gwang Yeogsi, 35015, South Korea

Location

Chungnam National University Hospital /ID# 259097

Daejeon, Daejeon Gwang Yeogsi, 35015, South Korea

Location

Daejeon Eulji Medical Center, Eulji University /ID# 251292

Daejeon, Daejeon Gwang Yeogsi, 35233, South Korea

Location

Daejeon Eulji Medical Center, Eulji University /ID# 251293

Daejeon, Daejeon Gwang Yeogsi, 35233, South Korea

Location

Konyang University Hospital /ID# 238951

Daejeon, Daejeon Gwang Yeogsi, 35365, South Korea

Location

Kangwon National University Hospital /ID# 248376

Chuncheon, Gang Weondo, 24289, South Korea

Location

Kangwon National University Hospital /ID# 259124

Chuncheon, Gang Weondo, 24289, South Korea

Location

Yonsei University-Wonju Severance Christian Hospital /ID# 239004

Wŏnju, Gang Weondo, 26426, South Korea

Location

Yonsei University-Wonju Severance Christian Hospital /ID# 239005

Wŏnju, Gang Weondo, 26426, South Korea

Location

Korea University Ansan Hospital /ID# 238992

Ansan-si, Gyeonggido, 15355, South Korea

Location

Korea University Ansan Hospital /ID# 251304

Ansan-si, Gyeonggido, 15355, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 240935

Bucheon-si, Gyeonggido, 14584, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 251321

Bucheon-si, Gyeonggido, 14584, South Korea

Location

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

Bucheon-si, Gyeonggido, 14647, South Korea

Location

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

Bucheon-si, Gyeonggido, 14647, South Korea

Location

Inje University - Ilsan Paik Hospital /ID# 270021

Goyang, Gyeonggido, 10380, South Korea

Location

Hanyang University Guri Hospital /ID# 259173

Guri-si, Gyeonggido, 11923, South Korea

Location

Hanyang University Guri Hospital /ID# 259175

Guri-si, Gyeonggido, 11923, South Korea

Location

Chung-Ang University Gwangmyeong Hospital /Id# 259180

Gwangmyeong, Gyeonggido, 04401, South Korea

Location

Chung-Ang University Gwangmyeong Hospital /ID# 270825

Gwangmyeong, Gyeonggido, 14353, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital /ID# 259177

Hwaseong, Gyeonggido, 18450, South Korea

Location

Gachon University Gil Medical Center /ID# 262757

Incheon, Gyeonggido, 21565, South Korea

Location

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

Incheon, Gyeonggido, 22711, South Korea

Location

CHA Bundang Medical Center /ID# 251324

Seongnam, Gyeonggido, 13496, South Korea

Location

CHA Bundang Medical Center /ID# 267001

Seongnam, Gyeonggido, 13496, South Korea

Location

Bundang Jesaeng Hospital /ID# 238999

Seongnam, Gyeonggido, 13590, South Korea

Location

Seoul National University Bundang Hospital /ID# 248378

Seongnam-si, Gyeonggido, 13620, South Korea

Location

Seoul National University Bundang Hospital /ID# 259115

Seongnam-si, Gyeonggido, 13620, South Korea

Location

Hallym University Sacred Heart Hospital /ID# 259150

Seoul, Gyeonggido, 14067, South Korea

Location

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

Suwon, Gyeonggido, 16247, South Korea

Location

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

Suwon, Gyeonggido, 16247, South Korea

Location

Ajou University Hospital /ID# 243488

Suwon, Gyeonggido, 16499, South Korea

Location

Ajou University Hospital /ID# 244494

Suwon, Gyeonggido, 16499, South Korea

Location

Ajou University Hospital /ID# 259123

Suwon, Gyeonggido, 16499, South Korea

Location

Uijeongbu Eulji Medical Center - Eulji University /ID# 259144

Uijeongbu-si, Gyeonggido, 11759, South Korea

Location

Uijeongbu Eulji Medical Center - Eulji University /ID# 270781

Uijeongbu-si, Gyeonggido, 11759, South Korea

Location

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

Uijeongbu-si, Gyeonggido, 11765, South Korea

Location

Yongin Severance Hospital /ID# 238948

Yŏngin, Gyeonggido, 16995, South Korea

Location

Yongin Severance Hospital /ID# 251311

Yŏngin, Gyeonggido, 16995, South Korea

Location

Daegu Catholic University Medical Center /ID# 238996

Daegu, Gyeongsangbuk-do, 42472, South Korea

Location

Keimyung University Dongsan Hospital /ID# 259172

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Keimyung University Dongsan Hospital /ID# 269942

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Samsung Changwon Hospital /ID# 239003

Changwon, Gyeongsangnam-do, 51353, South Korea

Location

Changwon Fatima Hospital /ID# 238958

Changwon-si, Gyeongsangnam-do, 51394, South Korea

Location

Gyeongsang National University Changwon Hospital /ID# 269931

Changwon-si, Gyeongsangnam-do, 51472, South Korea

Location

Gyeongsang National University Hospital /ID# 267003

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

Pusan National University Yangsan Hospital /ID# 239002

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Pusan National University Yangsan Hospital /ID# 259120

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

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

Incheon, Incheon Gwang Yeogsi, 21431, South Korea

Location

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

Incheon, Incheon Gwang Yeogsi, 21431, South Korea

Location

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

Incheon, Incheon Gwang Yeogsi, 21431, South Korea

Location

Inha University Hospital /ID# 251317

Incheon, Incheon Gwang Yeogsi, 21565, South Korea

Location

Design Hospital /ID# 262327

Jeollabuk-do, Jeonrabugdo, 54910, South Korea

Location

Jeonbuk National University Hospital /ID# 259140

Jeonju, Jeonrabugdo, 54907, South Korea

Location

Chosun University Hospital /ID# 259119

Gwangju, Jeonranamdo, 61453, South Korea

Location

Chonnam National University Hospital /ID# 251326

Gwangju, Jeonranamdo, 61469, South Korea

Location

Chungbuk National University Hospital /ID# 238997

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Chungbuk National University Hospital /ID# 262334

Cheongju-si, North Chungcheong, 28644, South Korea

Location

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

Chungbuk, North Chungcheong, 28641, South Korea

Location

Konkuk University Chungju Hospital /ID# 240936

Chungju, North Chungcheong, 27376, South Korea

Location

Sejong Chungnam National University Hospital /ID# 238952

Sejong-si, Sejong-si, 30099, South Korea

Location

Sejong Chungnam National University Hospital /ID# 259216

Sejong-si, Sejong-si, 30099, South Korea

Location

Chungang University Hospital /ID# 238993

Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea

Location

Chungang University Hospital /ID# 251322

Dongjak-gu, Seoul Teugbyeolsi, 06973, South Korea

Location

Inje University Sanggye Paik Hospital /ID# 251316

Seoul, Seoul Teugbyeolsi, 01757, South Korea

Location

Nowon Eulji Medical Center, Eulji University /ID# 259139

Seoul, Seoul Teugbyeolsi, 01830, South Korea

Location

Seoul Medical Center /ID# 251310

Seoul, Seoul Teugbyeolsi, 02053, South Korea

Location

Kyung Hee University Hospital /ID# 259117

Seoul, Seoul Teugbyeolsi, 02447, South Korea

Location

Kyung Hee University Hospital /ID# 270182

Seoul, Seoul Teugbyeolsi, 02447, South Korea

Location

Korea University Anam Hospital /ID# 262333

Seoul, Seoul Teugbyeolsi, 02841, South Korea

Location

Seoul National University Hospital /ID# 245209

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Seoul National University Hospital /ID# 251319

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Kangbuk Samsung Hospital /ID# 238955

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

Kangbuk Samsung Hospital /ID# 251308

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 259178

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

SoonChunHyang University Seoul Hospital /ID# 259179

Seoul, Seoul Teugbyeolsi, 04401, South Korea

Location

SoonChunHyang University Seoul Hospital /ID# 269940

Seoul, Seoul Teugbyeolsi, 04401, South Korea

Location

National Medical Center /ID# 251303

Seoul, Seoul Teugbyeolsi, 04564, South Korea

Location

Hanyang University Seoul Hospital /ID# 238640

Seoul, Seoul Teugbyeolsi, 04763, South Korea

Location

Hanyang University Seoul Hospital /ID# 251320

Seoul, Seoul Teugbyeolsi, 04763, South Korea

Location

Konkuk University Medical Center /ID# 245208

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Rheuma Internal Clinic /ID# 238998

Seoul, Seoul Teugbyeolsi, 05119, South Korea

Location

Asan Bone Internal Medicine /ID# 238991

Seoul, Seoul Teugbyeolsi, 05257, South Korea

Location

Kyung Hee University Hospital at Gangdong /ID# 267000

Seoul, Seoul Teugbyeolsi, 05278, South Korea

Location

Kyung Hee University Hospital at Gangdong /ID# 267004

Seoul, Seoul Teugbyeolsi, 05278, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 05368, South Korea

Location

Asan Medical Center /ID# 251312

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Gangnam Severance Hospital /ID# 270030

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

Samsung Medical Center /ID# 259152

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

SMG-SNU Boramae Medical Center /ID# 238957

Seoul, Seoul Teugbyeolsi, 07061, South Korea

Location

SMG-SNU Boramae Medical Center /ID# 251325

Seoul, Seoul Teugbyeolsi, 07061, South Korea

Location

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

Seoul, Seoul Teugbyeolsi, 07345, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 262328

Seoul, Seoul Teugbyeolsi, 07441, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 270775

Seoul, Seoul Teugbyeolsi, 07441, South Korea

Location

Ewha Womans University Seoul Hospital /ID# 251327

Seoul, Seoul Teugbyeolsi, 07804, South Korea

Location

Ewha Womans University Medical Centre /ID# 270025

Seoul, Seoul Teugbyeolsi, 07985, South Korea

Location

Korea University Guro Hospital /ID# 259141

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956

Seoul, Seoul Teugbyeolsi, 50612, South Korea

Location

Myungji Hospital /Id# 259148

Goyang, 10475, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 248377

Seoul, 03722, South Korea

Location

Duplicate_Inje University Seoul Paik Hospital /ID# 238994

Seoul, 04551, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital /ID# 251328

Seoul, 05355, South Korea

Location

Hallym University Sacred Heart Hospital /ID# 269934

Seoul, 14068, South Korea

Location

Related Links

• Related Info.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Dermatitis, Atopic; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 9, 2020
• Study Start: January 26, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

KR (116)