Ulcerative ColitisNCT06459297
Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's Disease
An observational study of Ulcerative Colitis and Crohn's Disease, run by AbbVie at 14 sites in South Korea.
Trial summary
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 105 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 24 Jun 2024to 9 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with ulcerative colitis or Crohn's Disease
Who may be able to join
- 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.
Who cannot join
- Participants with any contraindication to Upadacitinib.
- Participants currently participating in another clinical research not including observational study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
SoonChunHyang University Hospital Cheonan /ID# 270015
Cheonan-si, Chungcheongnam-do, 31151
Keimyung University Dongsan Hospital /ID# 269775
Daegu, Gyeongsangbuk-do, 42601
Yeungnam University Medical Center /ID# 269992
Daegu, 42415
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 267843
Daejeon, Daejeon Gwang Yeogsi, 34943
Kyung Hee University Hospital /ID# 270003
Dongdaemun-gu, Seoul Teugbyeolsi, 02447
Inje University - Ilsan Paik Hospital /ID# 269995
Goyang-si, Gyeonggido, 10380
Chosun University Hospital /ID# 269990
Gwangju, Jeonranamdo, 61453
Seoul Songdo Hospital /ID# 270009
Junggu, 04597
Yonsei University Health System Severance Hospital /ID# 268865
Seoul, Seoul Teugbyeolsi, 03722
Gangnam Severance Hospital /ID# 270020
Seoul, Seoul Teugbyeolsi, 06273
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 270014
Seoul, Seoul Teugbyeolsi, 06591
Hallym University Kangnam Sacred Heart Hospital /ID# 270013
Seoul, Seoul Teugbyeolsi, 07441
Ewha Womans University Medical Centre /ID# 269776
Seoul, Seoul Teugbyeolsi, 07985
Ulsan University Hospital /ID# 270006
Ulsan, Ulsan Gwang Yeogsi, 44033
About this study
Official title: Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed.
Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea.
Read more
Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 52 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Inflammatory Bowel Diseases, Upadacitinib, RINVOQ, Ulcerative colitis, Crohn's Disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Participants will receive upadacitinib as prescribed by their physician according to local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who reported Serious Adverse Event
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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Up to 52 weeks
Percentage of participants who reported Serious Adverse Drug Reaction
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Percentage of participants who reported known (labeled) Adverse Drug Reaction
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Percentage of participants who reported the events related to important identified risks/important potential risks/missing information
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start24 Jun 2024
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459297
- Sponsor's protocol ID
- P24-081
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease
- ClinicalTrials.gov ID
- NCT06459297
- Acronym / sponsor ID
- P24-081
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Inflammatory Bowel Diseases, Upadacitinib, RINVOQ, Ulcerative colitis, Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed.
Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea.
Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 52 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | – | –Participants will receive upadacitinib as prescribed by their physician according to local label. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with ulcerative colitis or Crohn's Disease
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants with any contraindication to Upadacitinib.
- Participants currently participating in another clinical research not including observational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants who reported Serious Adverse Event
Time frame: Up to 52 weeks
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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of participants who reported Serious Adverse Drug Reaction
Time frame: Up to 52 weeks
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction
Time frame: Up to 52 weeks
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported known (labeled) Adverse Drug Reaction
Time frame: Up to 52 weeks
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction
Time frame: Up to 52 weeks
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported the events related to important identified risks/important potential risks/missing information
Time frame: Up to 52 weeks
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. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by AbbVie at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who reported Serious Adverse Event (time frame: Up to 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.