UCRecruiting
A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Observational · No treatment assigned · 10 sites · Xian-Janssen Pharmaceutical Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colitis, Ulcerative. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (>=) 2; c) Mayo rectal bleeding…
- Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
- Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors…
- Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-12-11.
- Main results expected around 2028-06-30 (estimate from the record).
- 10 study sites listed (10 marked recruiting) in China.
Groups in this study
- Guselkumab: Moderate to Severe Ulcerative Colitis (UC)
Main thing being measured
- Percentage of Participants Achieving Clinical Response at Week 12 (At Week 12)
In the researchers’ words
The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received…
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
- JAK inhibitor: a group of oral medicines that calm parts of the immune system.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colitis, Ulcerative |
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. |
| Enrollment | 200 (estimated) |
| Start date | 2025-12-11 |
| Primary completion (est.) | 2028-06-30 |
| First posted | 2025-12-24 |
| Last updated | 2026-09-25 |
| Official title | Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study |
| ClinicalTrials.gov ID | NCT07302360 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion criteria: * Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (>=) 2; c) Mayo rectal bleeding subscore (RBS) >= 1 at baseline * Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert * Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment * Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements Exclusion criteria: * Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy * Contraindicated to guselkumab per the label * Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab * Participants who will be receiving guselkumab therapy combined with a second advanced therapy * Participants with a history of colectomy and/or pouch
Locations (10)
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China | Recruiting |
| Peking University People's Hospital | Beijing | China | Recruiting |
| Changzhou No 2 Peoples Hospital | Changzhou | China | Recruiting |
| The First Affiliated Hospital Sun Yat-Sen University | Guangzhou | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | China | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | China | Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang | China | Recruiting |
| Tianjin Medical University General Hospital | Tianjin | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.