An observational study in Colitis, Ulcerative, sponsored by Xian-Janssen Pharmaceutical Ltd.. Recruiting at 11 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Xian-Janssen Pharmaceutical Ltd. (part of Johnson & Johnson) · Observational
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 200 is close to the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Xian-Janssen Pharmaceutical Ltd. is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
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Eligible Chinese participants with moderate-to-severe UC who are bio-naive will be consecutively enrolled in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 12
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 48
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 2
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 2
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 2
Percentage of Participants Achieving Clinical Remission at Week 12, Week 24 and Week 48
Clinical remission is defined as a partial Mayo score less than or equal to (\<=) 2 with no sub-score greater than (\>) 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 12, Week 24 and Week 48
Percentage of Participants Achieving Symptomatic Remission at Week 2
Symptomatic remission as measured by PRO-2 is defined as a SFS of 0 or 1 and an RBS of 0, where the SFS has not increased from induction baseline. The SFS 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 RBS 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 2
Percentage of Participants Achieving Steroid-Free Remission at Week 12, 24 and 48
Steroid-free remission is defined as clinical remission with no use of corticosteroids for at least 30 days. Clinical remission is defined as partial Mayo score \<= 2 with no sub-score \>1.
Time frame: At Weeks 12, 24 and 48
Percentage of Participants Achieving Sustained Remission at Week 24 and Week 48
Sustained remission is defined as clinical remission maintenance status at post-induction (Week 12) in participants who had attained clinical remission by the end of the 12-week induction therapy.
Time frame: At Week 24 and Week 48
Percentage of Participants with Endoscopic Improvement (Healing) at Week 24 and Week 48
Endoscopic improvement (healing) is defined as endoscopic remission Mayo endoscopic subscore (MES) of 0 or 1. The MES consists of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each subscore is graded from 0 (normal) to 3 (severe) with higher scores indicate more severe disease.
Time frame: At Week 24 and Week 48
Percentage of Participants Achieving Endoscopic Remission (Normalization) at Week 24 and Week 48
Endoscopic remission (normalization) is defined as an MES of 0. The MES consists of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each subscore is graded from 0 (normal) to 3 (severe) where higher scores indicate more severe disease.
Time frame: At Week 24 and Week 48
Percentage of Participants Discontinuing from Treatment
Treatment discontinuation is defined as discontinuation of guselkumab treatment for any reason.
Time frame: Up to Week 48
Percentage of Participants Switching from Treatment
Treatment switch is defined as initiation of another medication for UC treatment after guselkumab discontinuation.
Time frame: Up to Week 48
Time to Treatment Discontinuation
Time to treatment discontinuation is defined as the time from the guselkumab start date to the time of treatment discontinuation.
Time frame: Up to Week 48
Time to Treatment Switch
Time to treatment switch is defined as the time from the guselkumab start date to the time of initiation of a new treatment other than guselkumab.
Time frame: Up to Week 48
Percentage of Participants on Guselkumab Dosing Schedules of 200 Milligrams (mg) Once Every 4 Weeks (q4w) or 100 mg Once Every 8 Weeks (q8w)
The percentage of participants on guselkumab dosing schedules of 200mg q4w or 100 mg q8w will be assessed. For each dosing schedule, the percentage will be calculated by dividing the number of participants receiving the specific dosing regimen by the number of participants still being followed up at those time points, multiplied by 100%.
Time frame: From Baseline through Week 12 to Week 48
Percentage of Participants Undergoing Dose Escalation/ De-Escalation
Percentage of participants having dose escalation/ de-escalation during maintenance treatment will be assessed. The percentage will be calculated by dividing the number of participants having dosage adjustment (that is, dose escalation/de-escalation) after Week 0 at any visit time point compared to his/her previous recorded administration dosage, multiplied by 100%.
Time frame: Week 12 up to Week 48
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
IBDQ remission is defined as total IBDQ score \>= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for patients with inflammatory bowel disease that will be used to evaluate the disease-specific health-related quality of life (QoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Time frame: At Week 12, Week 24 and Week 48
Change from Baseline in C-Reactive Protein (CRP) Levels
Change in CRP levels since guselkumab initiation will be reported.
Time frame: Baseline, Week 12, Week 24 and Week 48
Change from Baseline of Fecal Calprotectin Levels
Change in fecal calprotectin levels since guselkumab initiation will be reported.
Time frame: Baseline, Week 12, Week 24 and Week 48
Percentage of Participants Achieving CRP Normalization
Normalization of CRP is defined as reduction of less than or equal to 5 microgram per liter (mg/L) at weeks 12, 24 and 48 since baseline. Percentage of participants with abnormal CRP at baseline achieving CRP normalization will be reported.
Time frame: At Week 12, Week 24 and Week 48
Percentage of Participants Achieving Fecal Calprotectin (FCP) Normalization
Normalization of fecal calprotectin is defined as reduction of \<= 250 microgram per gram (mcg/g) at weeks 12, 24 and 48 since baseline. Percentage of participants with abnormal FCP at baseline achieving fecal calprotectin normalization will be reported.
Time frame: At Week 12, Week 24 and Week 48
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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