A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Recruiting · NCT07302360 · Observational (researchers observe without assigning treatment) · Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
10 locations listed.
- Peking Union Medical College Hospital - Beijing, China
- Peking University People's Hospital - Beijing, China
- Changzhou No 2 Peoples Hospital - Changzhou, China
- The First Affiliated Hospital Sun Yat-Sen University - Guangzhou, China
- The Sixth Affiliated Hospital of Sun Yat-sen University - Guangzhou, China
- The Second Affiliated Hospital of Zhejiang University - Hangzhou, China
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou, China
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School - Nanjing, China
- The Second Hospital of Hebei Medical University - Shijiazhuang, China
- Tianjin Medical University General Hospital - Tianjin, China