Assessing the effects of Upadacitinib in Korean patients with various inflammatory conditions
Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib in Korean Patients
This study is testing if the oral medication Upadacitinib is safe and effective for Korean adults and teens with moderate to severe inflammatory conditions like rheumatoid arthritis and atopic dermatitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 116 sites (Busan, Busan Gwang Yeogsi and 115 other locations) |
| Trial ID | NCT04541810 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of oral Upadacitinib tablets in Korean participants suffering from moderate to severe active rheumatoid arthritis, atopic dermatitis, ankylosing spondylitis, or psoriatic arthritis. The study aims to monitor adverse events and changes in disease symptoms among these patients. Participants must meet specific eligibility criteria, including being adults or adolescents suitable for Upadacitinib treatment as per local guidelines. The study is conducted at multiple locations in Busan, South Korea.
Who should consider this trial
Good fit: Ideal candidates include Korean adults aged 19 and older, and adolescents aged 12 and older with atopic dermatitis, who are eligible for Upadacitinib treatment.
Not a fit: Patients for whom Upadacitinib is contraindicated according to the approved local label may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of Upadacitinib for managing symptoms in patients with these inflammatory conditions.
How similar studies have performed: Other studies have shown promising results with Upadacitinib in treating similar inflammatory conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Busan, Busan Gwang Yeogsi and 115 other locations
- Inje University - Busan Paik Hospital /ID# 259143 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Haeundae Bumin Hospital /ID# 238959 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Inje University Haeundae Hospital /ID# 238949 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Pusan National University Hospital /ID# 251315 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Kosin University Gospel Hospital /ID# 239001 — Busan, Busan Gwang Yeogsi, Korea, Republic of (Recruiting)
- Chungbuk National University Hospital /ID# 238997 — Cheongju, Chungcheongbugdo, Korea, Republic of (Recruiting)
- Chungbuk National University Hospital /ID# 262334 — Cheongju, Chungcheongbugdo, Korea, Republic of (Recruiting)
- Dr. Park's Internal Medicine Clinic /ID# 238995 — Chungbuk, Chungcheongbugdo, Korea, Republic of (Recruiting)
- Konkuk University Chungju Hospital /ID# 240936 — Chungju, Chungcheongbugdo, Korea, Republic of (Recruiting)
- Dankook University Hospital /ID# 251307 — Cheonan-si, Chungcheongnamdo, Korea, Republic of (Recruiting)
- SoonChunHyang University Hospital Cheonan /ID# 248379 — Cheonan-si, Chungcheongnamdo, Korea, Republic of (Recruiting)
- SoonChunHyang University Hospital Cheonan /ID# 251302 — Cheonan-si, Chungcheongnamdo, Korea, Republic of (Recruiting)
- Kyungpook National University Hospital /ID# 251294 — 중구, Daegu Gwang Yeogsi, Korea, Republic of (Recruiting)
- Kyungpook National University Hospital /ID# 251305 — 중구, Daegu Gwang Yeogsi, Korea, Republic of (Recruiting)
- Chungnam National University Hospital /ID# 239000 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (Recruiting)
- Chungnam National University Hospital /ID# 259097 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (Recruiting)
- Daejeon Eulji Medical Center, Eulji University /ID# 251292 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (Recruiting)
- Daejeon Eulji Medical Center, Eulji University /ID# 251293 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (Recruiting)
- Konyang University Hospital /ID# 238951 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (Recruiting)
- Kangwon National University Hospital /ID# 248376 — Chuncheon, Gang Weondo, Korea, Republic of (Recruiting)
- Kangwon National University Hospital /ID# 259124 — Chuncheon, Gang Weondo, Korea, Republic of (Recruiting)
- Yonsei University-Wonju Severance Christian Hospital /ID# 239004 — Wonju, Gang Weondo, Korea, Republic of (Recruiting)
- Yonsei University-Wonju Severance Christian Hospital /ID# 239005 — Wonju, Gang Weondo, Korea, Republic of (Recruiting)
- Korea University Ansan Hospital /ID# 238992 — Ansan-si, Gyeonggido, Korea, Republic of (Recruiting)
- Korea University Ansan Hospital /ID# 251304 — Ansan-si, Gyeonggido, Korea, Republic of (Recruiting)
- Soon Chun Hyang University Hospital Bucheon /ID# 240935 — Bucheon-si, Gyeonggido, Korea, Republic of (Recruiting)
- Soon Chun Hyang University Hospital Bucheon /ID# 251321 — Bucheon-si, Gyeonggido, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 259142 — Bucheon, Gyeonggido, Korea, Republic of (Recruiting)
- Chungang University Hospital /ID# 238993 — Dongjak-gu, Gyeonggido, Korea, Republic of (Recruiting)
- Chungang University Hospital /ID# 251322 — Dongjak-gu, Gyeonggido, Korea, Republic of (Recruiting)
- Hanyang University Guri Hospital /ID# 259173 — Guri-si, Gyeonggido, Korea, Republic of (Recruiting)
- Hanyang University Guri Hospital /ID# 259175 — Guri-si, Gyeonggido, Korea, Republic of (Recruiting)
- Chung-Ang University Gwangmyeong Hospital /Id# 259180 — Gwangmyeong, Gyeonggido, Korea, Republic of (Recruiting)
- Hallym University Dongtan Sacred Heart Hospital /ID# 259177 — Hwaseong, Gyeonggido, Korea, Republic of (Recruiting)
- Gachon University Gil Medical Center /ID# 262757 — Incheon, Gyeonggido, Korea, Republic of (Recruiting)
- Catholic Kwandong University International St.Mary's Hospital /ID# 248380 — Incheon, Gyeonggido, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital /ID# 248378 — Seongnam-si, Gyeonggido, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital /ID# 259115 — Seongnam-si, Gyeonggido, Korea, Republic of (Recruiting)
- CHA Bundang Medical Center /ID# 251324 — Seongnam, Gyeonggido, Korea, Republic of (Recruiting)
- CHA Bundang Medical Center /ID# 267001 — Seongnam, Gyeonggido, Korea, Republic of (Recruiting)
- Bundang Jesaeng Hospital /ID# 238999 — Seongnam, Gyeonggido, Korea, Republic of (Recruiting)
- Hallym University Sacred Heart Hospital /ID# 259150 — Seoul, Gyeonggido, Korea, Republic of (Recruiting)
- Ajou University Hospital /ID# 243488 — Suwon-si, Gyeonggido, Korea, Republic of (Recruiting)
- Ajou University Hospital /ID# 244494 — Suwon-si, Gyeonggido, Korea, Republic of (Recruiting)
- Ajou University Hospital /ID# 259123 — Suwon-si, Gyeonggido, Korea, Republic of (Recruiting)
- The Catholic University Of Korea St. Vincent's Hospital /ID# 245207 — Suwon, Gyeonggido, Korea, Republic of (Recruiting)
- The Catholic University Of Korea St. Vincent's Hospital /ID# 259149 — Suwon, Gyeonggido, Korea, Republic of (Recruiting)
- Uijeongbu Eulji Medical Center - Eulji University /ID# 259144 — Uijeongbu, Gyeonggido, Korea, Republic of (Recruiting)
- Uijeongbu Eulji Medical Center - Eulji University /ID# 270781 — Uijeongbu, Gyeonggido, Korea, Republic of (Recruiting)
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 259182 — Uijeongbu, Gyeonggido, Korea, Republic of (Recruiting)
+66 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Hansol Lee
- Email: hansol.lee@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.