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
This trial does not accept healthy volunteersQualifiers
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 population
Eligible Chinese participants with moderate-to-severe UC who are bio-naive will be consecutively enrolled in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Guselkumab: Moderate to Severe Ulcerative Colitis (UC)
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving Clinical Response at Week 12
Clinical response is defined as a decrease from baseline in the partial Mayo score by \>= 30 percent (%) and \>= 2 points, with either a \>=1 decrease from baseline in rectal bleeding subscore (RBS) or an RBS of 0 or 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.
Time frame
At Week 12Secondary outcomes
1
Percentage of Participants Achieving Clinical Response at Week 24 and Week 48
Clinical response is defined as a decrease from baseline in the partial Mayo score by \>= 30 % and \>= 2 points, with either a \>=1 decrease from baseline in RBS or an RBS of 0 or 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.
Time frame
At Week 24 and Week 482
Percentage of Participants Achieving Symptomatic Response at Week 2
Symptomatic response is defined as a decrease from induction baseline in the patient reported outcome (PRO)-2 by at least 30% and at least 1 point, with either at least 1-point decrease from induction baseline in RBS or an RBS of 0 or 1. PRO-2 consists of the two components (rectal bleeding and stool frequency). The stool frequency subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The rectal bleeding subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). Higher score indicates more severity in symptoms.
Time frame
At Week 23
Mean Change from Baseline in Stool Frequency Subscore (SFS) Over Week 2
SFS is a component of PRO-2. The stool frequency subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). Higher score indicates more severity in symptoms.
Time frame
From Baseline to Week 24
Mean Change from Baseline in RBS Over Week 2
RBS is a component of PRO-2. The rectal bleeding subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). Higher score indicates more severity in symptoms.
Time frame
From Baseline to Week 2Sponsors and contacts
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Source ClinicalTrials.gov