Guselkumab for Chinese patients with moderate-to-severe ulcerative colitis in routine care
Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study
This project will try guselkumab in Chinese adults with moderate-to-severe ulcerative colitis who have never used biologic therapies to see how their symptoms, endoscopic appearance, and quality of life change in routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xian-Janssen Pharmaceutical Ltd. Industry-sponsored |
| Drugs / interventions | guselkumab |
| Locations | 9 sites (Beijing and 8 other locations) |
| Trial ID | NCT07302360 on ClinicalTrials.gov |
What this trial studies
This observational, real-world study follows biologic‑naive Chinese participants with moderate-to-severe ulcerative colitis who start guselkumab as part of routine care. Eligible participants have a modified Mayo score of 4–9, endoscopic Mayo subscore ≥2, and rectal bleeding subscore ≥1 at baseline, and they initiate treatment per their physician's decision. Clinical outcomes, endoscopic findings, patient-reported function and quality-of-life measures, and routine safety data will be collected from medical records and clinic visits. The study aims to characterize the effectiveness and tolerability of guselkumab in everyday clinical practice in this population.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults with moderately to severely active UC (modified Mayo 4–9, endoscopic subscore ≥2, rectal bleeding subscore ≥1) who are biologic‑naive and are starting guselkumab under their physician's care.
Not a fit: Patients with prior exposure to biologic or other advanced therapies, those with acute severe ulcerative colitis, or those not initiating guselkumab per physician decision are unlikely to benefit from this observational project.
Why it matters
Potential benefit: If successful, the results could support guselkumab as an effective option to reduce symptoms, promote mucosal healing, and improve quality of life for biologic‑naive Chinese UC patients.
How similar studies have performed: IL‑23 pathway therapies and some guselkumab trials have shown promise in inflammatory bowel disease, but real‑world data specifically in Chinese biologic‑naive UC patients remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing and 8 other locations
- 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)
- 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)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
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.