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Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
SUMMARY

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 biologic therapy (a medicine made from living organisms or their components) previously.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
The First Affiliated Hospital Sun Yat-Sen University
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 200
Treatments
Guselkumab: Moderate to Severe Ulcerative Colitis (UC)
Participants with confirmed diagnosis of moderate-to-severe UC treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected and observed.
Sponsors
Leads: Xian-Janssen Pharmaceutical Ltd.

This content was sourced from clinicaltrials.gov