Ulcerative ColitisNCT06838845
An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)
An observational study of Ulcerative Colitis, run by AbbVie at 3 sites in China.
Trial summary
Ulcerative colitis (UC) is a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus.. This study will assess how effective upadacitinib is in treating UC within a Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- 9 Apr 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adult participants with diagnosis of moderate to severe UC with Tumor Necrosis Factor Inhibitor-Inadequate Responder (TNF-IR) or have contraindications to Tumor Necrosis Factor (TNF) blockers, and commenced on upadacitinib treatment prescribed as part of their routine clinical care at their clinician's discretion according to locally approved label and local treatment prescription recommendations/guidelines.
Who may be able to join
- Chinese participants meet the diagnosis of moderately to severely active Ulcerative colitis (UC)
- Participants prescribed upadacitinib at discretion of their treating physicians based on sufficient consideration of benefits/risks for patients per local label
- Participant must be an adult (≥ 18 years)
- Participant must provide written authorization to use personal and/or health data prior to the entry into the study
Who cannot join
- Participant participating in any interventional trials
- Participant with any contraindication to upadacitinib as listed on the local China label
- Participant unwilling or unable to comply with the study requirements, including completion of patient reported outcome questionnaires
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yuting Xie contact
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997
Guangzhou, Guangdong, 510080
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753
Guangzhou, Guangdong, 510655
- Recruiting
The Second Affiliated Hospital Of Zhengzhou University /ID# 274754
Zhengzhou, Henan, 450014
About this study
Official title: Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China
Ulcerative colitis (UC) is a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus.. This study will assess how effective upadacitinib is in treating UC within a Chinese population.
Upadacitinib is an approved drug for treating UC. Approximately 80 adult participants, who have been prescribed upadacitinib for UC by their physician in accordance with local label, will be enrolled in China.
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 1 year.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
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.
Achievement of clinical response per partial adapted Mayo score.
Defined as a decrease in Partial Adapted Mayo score of ≥ 1 point and a decrease of ≥ 30% from Baseline, PLUS either a decrease in rectal bleeding sub-score (RBS) of ≥ 1 point or an absolute RBS of ≤ 1.
Measured: At Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start9 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 80 participants (estimated)
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
- NCT06838845
- Sponsor's protocol ID
- P25-085
- Status last verified
- Nov 2025
- First submitted
- 17 Feb 2025
- Last updated
- 26 Nov 2025
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China
- ClinicalTrials.gov ID
- NCT06838845
- Acronym / sponsor ID
- P25-085
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Feb 2025 (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 a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus.. This study will assess how effective upadacitinib is in treating UC within a Chinese population.
Upadacitinib is an approved drug for treating UC. Approximately 80 adult participants, who have been prescribed upadacitinib for UC by their physician in accordance with local label, will be enrolled in China.
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 1 year.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult participants with diagnosis of moderate to severe UC with Tumor Necrosis Factor Inhibitor-Inadequate Responder (TNF-IR) or have contraindications to Tumor Necrosis Factor (TNF) blockers, and commenced on upadacitinib treatment prescribed as part of their routine clinical care at their clinician's discretion according to locally approved label and local treatment prescription recommendations/guidelines.
Key inclusion criteria (4 listed)
- Chinese participants meet the diagnosis of moderately to severely active Ulcerative colitis (UC)
- Participants prescribed upadacitinib at discretion of their treating physicians based on sufficient consideration of benefits/risks for patients per local label
- Participant must be an adult (≥ 18 years)
- Participant must provide written authorization to use personal and/or health data prior to the entry into the study
Key exclusion criteria (3 listed)
- Participant participating in any interventional trials
- Participant with any contraindication to upadacitinib as listed on the local China label
- Participant unwilling or unable to comply with the study requirements, including completion of patient reported outcome questionnaires
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
Achievement of clinical response per partial adapted Mayo score.
Time frame: At Week 8
Defined as a decrease in Partial Adapted Mayo score of ≥ 1 point and a decrease of ≥ 30% from Baseline, PLUS either a decrease in rectal bleeding sub-score (RBS) of ≥ 1 point or an absolute RBS of ≤ 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- 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.
Yuting Xie contact
ABBVIE INC. study director
AbbVie
3 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, run by AbbVie at 3 sites in China.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Xie (yuting.xie@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of clinical response per partial adapted Mayo score. (time frame: At Week 8). 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 26 Nov 2025.