RECRUITINGOBSERVATIONAL
A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis
Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form (ICF) allowing source data verification in accordance with local requirements
Who Should NOT Join This Trial:
- 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 willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 (1)
The Second Hospital of Hebei Medical University
Shijiazhuang, China