Assessing the effects of Upadacitinib on ulcerative colitis and Crohn's disease
Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease
AbbVie · NCT06459297
This study is testing how well Upadacitinib works and how safe it is for adults with moderate to severe ulcerative colitis or Crohn's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AbbVie (industry) |
| Drugs / interventions | Upadacitinib |
| Locations | 14 sites (Cheonan-si, Chungcheongnamdo and 13 other locations) |
| Trial ID | NCT06459297 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of Upadacitinib in adult patients diagnosed with moderate to severe ulcerative colitis or Crohn's disease. Approximately 600 participants will be enrolled in Korea, where their disease activity and any adverse events will be monitored following their prescribed treatment with Upadacitinib. The treatment will be administered according to local marketing authorization, with the investigator determining the course of treatment. The study aims to gather real-world data on the drug's impact on these inflammatory bowel diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with moderate to severe ulcerative colitis or Crohn's disease who are prescribed Upadacitinib.
Not a fit: Patients with contraindications to Upadacitinib or those currently participating in other clinical research may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Upadacitinib for patients with ulcerative colitis and Crohn's disease.
How similar studies have performed: Other studies have shown promising results with Upadacitinib for treating ulcerative colitis and Crohn's disease, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants diagnosis with ulcerative colitis or Crohn's Disease suitable for the treatment with Upadacitinib. * Participants prescribed upadacitinib in accordance with the approved local label. Exclusion Criteria: * Participants with any contraindication to Upadacitinib. * Participants currently participating in another clinical research not including observational study.
Where this trial is running
Cheonan-si, Chungcheongnamdo and 13 other locations
- SoonChunHyang University Hospital Cheonan /ID# 270015 — Cheonan-si, Chungcheongnamdo, Korea, Republic of (RECRUITING)
- The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843 — Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Inje University - Ilsan Paik Hospital /ID# 269995 — 고양시, Gyeonggido, Korea, Republic of (RECRUITING)
- Keimyung University Dongsan Hospital /ID# 269775 — Daegu, Gyeongsangbugdo, Korea, Republic of (RECRUITING)
- Chosun University Hospital /ID# 269990 — Gwangju, Jeonranamdo, Korea, Republic of (RECRUITING)
- Kyung Hee University Hospital /ID# 270003 — Dongdaemun-gu, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Yonsei University Health System Severance Hospital /ID# 268865 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Gangnam Severance Hospital /ID# 270020 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Hallym University Kangnam Sacred Heart Hospital /ID# 270013 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Ewha Womans University Medical Centre /ID# 269776 — Seoul, Seoul Teugbyeolsi, Korea, Republic of (RECRUITING)
- Ulsan University Hospital /ID# 270006 — Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of (RECRUITING)
- Yeungnam University Medical Center /ID# 269992 — Daegu, Korea, Republic of (RECRUITING)
- Seoul Songdo Hospital /ID# 270009 — 중구, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: KyungJoo Kim
- Email: kyungjoo.kim@abbvie.com
- Phone: +82-10-3221-0662
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.
Conditions: Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Diseases, Upadacitinib, RINVOQ, Ulcerative colitis