An observational study in Ulcerative Colitis (Disorder) and Guselkumab, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational
In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound changes.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 97 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study employs a prospective consecutive enrollment design to include patients with moderate-to-severe active ulcerative colitis who are expected to receive guselkumab treatment at the study center based on clinical indications. The inclusion and exclusion criteria are as previously stated.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Guselkumab
All the patients receive GUS (IV) 200 mg induction therapy at weeks 0, 4, and 8, and who met the criteria for clinical symptom remission, biochemical remission, and improvement in intestinal ultrasound based on the clinical assessment at week 12, proceeded to receive GUS (SC) 100 mg every 8 weeks as maintenance therapy. Patients who did not meet the above criteria received GUS (SC) 200 mg every 4 weeks as maintenance therapy. At week 24, based on clinical and endoscopic evaluations, patients who achieved endoscopic remission were switched to GUS (SC) 100 mg every 8 weeks for maintenance, while those who did not achieve endoscopic remission continued to receive GUS (SC) 200 mg every 4 weeks for maintenance treatment.
48-week endoscopic remission
Assessment was performed using the Mayo endoscopic subscore: endoscopic response was defined as a decrease in the Mayo endoscopic subscore by at least 1 point from baseline or a score of ≤1; endoscopic remission was defined as a Mayo endoscopic subscore of 0. For patients who completed the 48-week treatment, endoscopic scores were evaluated, and the number/proportion of patients achieving endoscopic remission was calculated.
Time frame: 48 weeks
48-week histological remission
Investigators apply the Geboes score, and histological remission is defined as a Geboes score ≤ 2B.0. The Nancy Histological Index (NHI) is assessed concurrently, with histological remission defined as an NHI = 0 (indicating no active inflammation). Investigators performed histological scoring for patients who completed the 48-week treatment course and evaluated the number/proportion of patients achieving histological remission.
Time frame: 48 weeks
12-week clinical remission
Clinical remission in UC is assessed using the partial Mayo score (pMayo) or PRO2. It's defined as either a pMayo score ≤ 2 with no individual subscore \> 1, or meeting the symptomatic remission criteria of PRO2 (indicating improvement in both stool frequency and rectal bleeding scores to the mild or normal range).
Time frame: 12 weeks
12-week biochemical remission
1. CRP normalization (≤5 mg/L) or reduction by ≥50% from baseline. 2. Fecal calprotectin (FC) reduction to \<250 μg/g or reduction by ≥50% from baseline.
Time frame: 12 weeks
12-week intestinal ultrasound response
Response to intestinal ultrasound (IUS) was defined as meeting both of the following criteria: 1) a decrease in bowel wall thickness (BWT) by ≥25% or a reduction of ≥1 mm from baseline; and 2) a reduction in blood flow signal (Limberg score) by ≥1 grade.
Time frame: 12 weeks
24-week and 48-week intestinal ultrasound response
Intestinal ultrasound (IUS) remission was defined as meeting both of the following criteria: 1) bowel wall thickness (BWT) ≤ 3 mm; and 2) no detectable blood flow signal (Limberg grade 0).
Time frame: 24 weeks; 48 weeks
24-week endoscopic response and remission
Endoscopic response in UC was defined as a Mayo Endoscopic Score (MES) reduction of ≥1 point from baseline or a score of ≤1. Endoscopic remission was defined as an MES of 0.
Time frame: 24 weeks
24-week and 48-week Corticosteroid-free remission rate
Corticosteroid-free remission, a core treatment target recommended by the STRIDE-II guidelines, reflects a patient's ability to maintain clinical remission without the aid of systemic glucocorticoids. It is defined as achieving clinical remission at the assessment timepoint without the use of oral or intravenous glucocorticoids for at least 12 weeks prior to assessment. The proportion of UC patients achieving corticosteroid-free remission was documented for evaluation of the sustainability and steroid-sparing capacity of the treatment.
Time frame: 24 weeks; 48 weeks
48-week drug persistence rate
Drug persistence rate is defined as the proportion of patients who continue to receive a given drug after initiation of treatment. It reflects the tolerability, adherence, and long-term benefit of the therapy, and serves as a core indicator in real-world evidence (RWE) studies. Patients who discontinue treatment due to objective non-medical reasons (e.g., relocation, change of healthcare system) may be excluded in sensitivity analyses.
Time frame: 48 weeks
Hospitalization and surgery rates at week 48
1. Incidence of hospitalizations due to inadequate disease control and cumulative length of hospital stay. 2. Incidence and timing of intestinal resection or related surgeries performed due to disease activity or complications.
Time frame: 48 weeks
Impact of Prior Biologic Exposure on Efficacy
The clinical, endoscopic, intestinal ultrasound (IUS), and biochemical improvements were compared between biologic-naïve patients and patients with prior biologic therapy failure or intolerance. This analysis was performed to determine whether previous biologic exposure influences treatment outcomes.
Time frame: Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48.
Inflammatory Bowel Disease Questionnaire (IBD-Q) scores at week 48
1. A total score increase of ≥16 points from baseline is considered a clinically significant improvement. 2. Restoration to a normal or near-normal level (score ≥ 170) from an active disease state is considered achievement of quality of life remission.
Time frame: 48 weeks
Exploratory Study (Comparing the Efficacy of GUS and VDZ)
Patients with ulcerative colitis (UC) who had previously received vedolizumab (VDZ) treatment and had complete baseline and follow-up data were retrospectively enrolled from the study center. Propensity score matching analysis was performed to compare the effects of GUS and VDZ on multidimensional outcomes in moderate-to-severe UC in a real-world setting, including clinical response and remission, endoscopic remission, histological remission, and treatment persistence.
Time frame: Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48
Plan to share: Undecided
Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 188 non-industry observational studies under Colitis, Ulcerative, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 119. This study's planned 29 months is below that.
Counting every sponsor, half of 271 studies reached it within 47 months; a quarter within 29 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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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Second Affiliated Hospital of Wenzhou Medical University →