A Study of Oral Upadacitinib (RINVOQ) Tablets to Assess NCT04541810

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

Related Conditions & MeSH terms

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
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

See also
Status	Clinical Trial	Phase
Completed	`NCT05047341` - A Study of Human Substance Balance and Biotransformation of [14C]SHR0302	Phase 1
Withdrawn	`NCT02786563` - Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate
Completed	`NCT03257852` - A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate	Phase 2
Completed	`NCT03660059` - A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)	Phase 3
Recruiting	`NCT03971253` - Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Not yet recruiting	`NCT05486715` - Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
Completed	`NCT03682705` - A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis	Phase 2
Active, not recruiting	`NCT04574492` - A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis
Active, not recruiting	`NCT02805010` - Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously	Phase 1
Completed	`NCT01871961` - Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient	Phase 1
Completed	`NCT04497597` - A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
Terminated	`NCT02775656` - UCB Cimzia Pregnancy Follow-up Study
Completed	`NCT01173120` - Methotrexate - Inadequate Response Device Sub-Study	Phase 3
Completed	`NCT03223012` - Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
Completed	`NCT03086343` - A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs	Phase 3
Terminated	`NCT01569152` - Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)	Phase 2
Completed	`NCT02105129` - A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523	Phase 1
Completed	`NCT01577563` - Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).	N/A
Completed	`NCT01618955` - Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device	Phase 2
Completed	`NCT01618968` - Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device	Phase 2

External Links

Related Info.

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome

External Links