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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04541810
Other study ID # P20-319
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 26, 2021
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source AbbVie
Contact Hansol Lee
Phone 844-663-3742
Email hansol.lee@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3600
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Locations

Country Name City State
Korea, Republic of Korea University Ansan Hospital /ID# 238992 Ansan Gyeonggido
Korea, Republic of Korea University Ansan Hospital /ID# 251304 Ansan Gyeonggido
Korea, Republic of The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142 Bucheon Gyeonggido
Korea, Republic of Soon Chun Hyang University Hospital Bucheon /ID# 240935 Bucheon-si Gyeonggido
Korea, Republic of Soon Chun Hyang University Hospital Bucheon /ID# 251321 Bucheon-si Gyeonggido
Korea, Republic of Haeundae Bumin Hospital /ID# 238959 Busan
Korea, Republic of Inje University - Busan Paik Hospital /ID# 259143 Busan Busan Gwang Yeogsi
Korea, Republic of Inje University Haeundae Hospital /ID# 238949 Busan
Korea, Republic of Kosin University Gospel Hospital /ID# 239001 Busan Busan Gwang Yeogsi
Korea, Republic of Pusan National University Hospital /ID# 251315 Busan
Korea, Republic of Samsung Changwon Hospital /ID# 239003 Changwon
Korea, Republic of Changwon Fatima Hospital /ID# 238958 Changwon-si Gyeongsangnamdo
Korea, Republic of Dankook University Hospital /ID# 251307 Cheonan-si Chungcheongnamdo
Korea, Republic of SoonChunHyang University Hospital Cheonan /ID# 248379 Cheonan-si Chungcheongnamdo
Korea, Republic of SoonChunHyang University Hospital Cheonan /ID# 251302 Cheonan-si Chungcheongnamdo
Korea, Republic of Chungbuk National University Hospital /ID# 238997 Cheongju Chungcheongbugdo
Korea, Republic of Chungbuk National University Hospital /ID# 262334 Cheongju Chungcheongbugdo
Korea, Republic of Kangwon National University Hospital /ID# 248376 Chuncheon Gang Weondo
Korea, Republic of Kangwon National University Hospital /ID# 259124 Chuncheon Gang Weondo
Korea, Republic of Dr. Park's Internal Medicine Clinic /ID# 238995 Chungbuk
Korea, Republic of Konkuk University Chungju Hospital /ID# 240936 Chungju Chungcheongbugdo
Korea, Republic of Daegu Catholic University Medical Center /ID# 238996 Daegu Gyeongsangbugdo
Korea, Republic of Keimyung University Dongsan Hospital /ID# 259172 Daegu Gyeongsangbugdo
Korea, Republic of Kyungpook National University Hospital /ID# 251294 Daegu
Korea, Republic of Kyungpook National University Hospital /ID# 251305 Daegu
Korea, Republic of Chungnam National University Hospital /ID# 239000 Daejeon Daejeon Gwang Yeogsi
Korea, Republic of Chungnam National University Hospital /ID# 259097 Daejeon Daejeon Gwang Yeogsi
Korea, Republic of Daejeon Eulji Medical Center, Eulji University /ID# 251292 Daejeon
Korea, Republic of Daejeon Eulji Medical Center, Eulji University /ID# 251293 Daejeon
Korea, Republic of Konyang University Hospital /ID# 238951 Daejeon Daejeon Gwang Yeogsi
Korea, Republic of Chungang University Hospital /ID# 238993 Dongjak-gu Gyeonggido
Korea, Republic of Chungang University Hospital /ID# 251322 Dongjak-gu Gyeonggido
Korea, Republic of Myungji Hospital /Id# 259148 Goyang
Korea, Republic of Hanyang University Guri Hospital /ID# 259173 Guri-si Gyeonggido
Korea, Republic of Hanyang University Guri Hospital /ID# 259175 Guri-si Gyeonggido
Korea, Republic of Chonnam National University Hospital /ID# 251326 Gwangju Jeonranamdo
Korea, Republic of Chosun University Hospital /ID# 259119 Gwangju Jeonranamdo
Korea, Republic of Chung-Ang University Gwangmyeong Hospital /Id# 259180 Gwangmyeong Gyeonggido
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital /ID# 259177 Hwaseong Gyeonggido
Korea, Republic of Catholic Kwandong University International St.Mary's Hospital /ID# 248380 Incheon Gyeonggido
Korea, Republic of Gachon University Gil Medical Center /ID# 262757 Incheon Gyeonggido
Korea, Republic of Inha University Hospital /ID# 251317 Incheon Incheon Gwang Yeogsi
Korea, Republic of The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 240934 Incheon Incheon Gwang Yeogsi
Korea, Republic of The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 251306 Incheon Incheon Gwang Yeogsi
Korea, Republic of Design Hospital /ID# 262327 Jeollabuk-do
Korea, Republic of Jeonbuk National University Hospital /ID# 259140 Jeonju Jeonrabugdo
Korea, Republic of Gyeongsang National University Hospital /ID# 267003 Jinju Gyeongsangnamdo
Korea, Republic of Sejong Chungnam National University Hospital /ID# 238952 Sejong-si Sejong
Korea, Republic of Sejong Chungnam National University Hospital /ID# 259216 Sejong-si Sejong
Korea, Republic of Bundang Jesaeng Hospital /ID# 238999 Seongnam Gyeonggido
Korea, Republic of CHA Bundang Medical Center /ID# 251324 Seongnam Gyeonggido
Korea, Republic of CHA Bundang Medical Center /ID# 267001 Seongnam Gyeonggido
Korea, Republic of Seoul National University Bundang Hospital /ID# 248378 Seongnam-si Gyeonggido
Korea, Republic of Seoul National University Bundang Hospital /ID# 259115 Seongnam-si Gyeonggido
Korea, Republic of Asan Bone Internal Medicine /ID# 238991 Seoul
Korea, Republic of Asan Medical Center /ID# 251312 Seoul Seoul Teugbyeolsi
Korea, Republic of Duplicate_Inje University Seoul Paik Hospital /ID# 238994 Seoul
Korea, Republic of Ewha Womans University Seoul Hospital /ID# 251327 Seoul
Korea, Republic of Hallym University Kangdong Sacred Heart Hospital /ID# 251328 Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital /ID# 262328 Seoul
Korea, Republic of Hallym University Sacred Heart Hospital /ID# 259150 Seoul Gyeonggido
Korea, Republic of Hanyang University Seoul Hospital /ID# 238640 Seoul Seoul Teugbyeolsi
Korea, Republic of Hanyang University Seoul Hospital /ID# 251320 Seoul Seoul Teugbyeolsi
Korea, Republic of HoYounKim's Clinic for Arthritis Rheumatism /ID# 238956 Seoul
Korea, Republic of Inje University Sanggye Paik Hospital /ID# 251316 Seoul
Korea, Republic of Kangbuk Samsung Hospital /ID# 238955 Seoul Seoul Teugbyeolsi
Korea, Republic of Kangbuk Samsung Hospital /ID# 251308 Seoul Seoul Teugbyeolsi
Korea, Republic of Konkuk University Medical Center /ID# 245208 Seoul Seoul Teugbyeolsi
Korea, Republic of Korea University Anam Hospital /ID# 262333 Seoul
Korea, Republic of Korea University Guro Hospital /ID# 259141 Seoul Seoul Teugbyeolsi
Korea, Republic of Kyung Hee University Hospital at Gangdong /ID# 267004 Seoul
Korea, Republic of Kyung Hee University Medical Center /ID# 259117 Seoul
Korea, Republic of National Medical Center /ID# 251303 Seoul
Korea, Republic of Rheuma Internal Clinic /ID# 238998 Seoul
Korea, Republic of Samsung Medical Center /ID# 259152 Seoul
Korea, Republic of Seoul Medical Center /ID# 251310 Seoul
Korea, Republic of Seoul National University Hospital /ID# 245209 Seoul
Korea, Republic of Seoul National University Hospital /ID# 251319 Seoul
Korea, Republic of SMG-SNU Boramae Medical Center /ID# 238957 Seoul
Korea, Republic of SMG-SNU Boramae Medical Center /ID# 251325 Seoul
Korea, Republic of SoonChunHyang University Seoul Hospital /ID# 259179 Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245206 Seoul Seoul Teugbyeolsi
Korea, Republic of The Catholic University of Korea, Seoul St. Marys Hospital /ID# 251314 Seoul Seoul Teugbyeolsi
Korea, Republic of The Catholic University of Korea, Yeouido ST. Mary's Hospital /ID# 251309 Seoul
Korea, Republic of VHS(Veterans Health Service) Medical Center /ID# 251323 Seoul
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 248377 Seoul Seoul Teugbyeolsi
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 259178 Seoul Seoul Teugbyeolsi
Korea, Republic of The Catholic University Of Korea St. Vincent's Hospital /ID# 245207 Suwon Gyeonggido
Korea, Republic of The Catholic University Of Korea St. Vincent's Hospital /ID# 259149 Suwon Gyeonggido
Korea, Republic of Ajou University Hospital /ID# 243488 Suwon-si Gyeonggido
Korea, Republic of Ajou University Hospital /ID# 244494 Suwon-si Gyeonggido
Korea, Republic of Ajou University Hospital /ID# 259123 Suwon-si Gyeonggido
Korea, Republic of The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182 Uijeongbu Gyeonggido
Korea, Republic of Uijeongbu Eulji Medical Center - Eulji University /ID# 259144 Uijeongbu Gyeonggido
Korea, Republic of Yonsei University-Wonju Severance Christian Hospital /ID# 239004 Wonju Gang Weondo
Korea, Republic of Yonsei University-Wonju Severance Christian Hospital /ID# 239005 Wonju Gang Weondo
Korea, Republic of Pusan National University Yangsan Hospital /ID# 239002 Yangsan-si Gyeongsangnamdo
Korea, Republic of Pusan National University Yangsan Hospital /ID# 259120 Yangsan-si Gyeongsangnamdo
Korea, Republic of Yongin Severance Hospital /ID# 238948 Yongin
Korea, Republic of Yongin Severance Hospital /ID# 251311 Yongin

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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