A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
ConditionColitis, Ulcerative
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXian-Janssen Pharmaceutical Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov