Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Diagnosis of ulcerative colitis is established based on clinical manifestations, laboratory findings, colonoscopy, radiological imaging (CT or ultrasound), and histopathological examination.
Presence of moderate-to-severe disease activity, defined as a modified Mayo score (MMS) ≥ 5 points, accompanied by a rectal bleeding subscore (RBS) ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2.
Inadequate response or intolerance to at least one conventional therapy (5-aminosalicylates, corticosteroids, or immunosuppressants), as assessed by the investigator according to clinical practice.
Disqualifiers
Diagnosed with other intestinal diseases, such as Crohn's disease, intestinal tuberculosis, infectious colitis, ischemic colitis or other chronic intestinal inflammatory diseases;
If there is an active intestinal infection, and the fecal culture or pathogen test shows positive within 8 weeks before the study (including Clostridium difficile, cytomegalovirus, etc.), and the re-examination turns negative without any signs of persistent infection, a re-evaluation can be conducted.
Combined with severe infections, malignant tumors, severe liver and kidney dysfunction, or accompanied by active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, and Graves' disease that may interfere with disease assessment
Those who have undergone total colorectal resection or stoma surgery in the past and whose disease activity cannot be evaluated, or are expected to undergo major intestinal surgery during the study period;
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Guselkumab
DrugAll 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.
Treatment groups
97 Participants
are divided into 1 treatment groupGroup A: Guselkumab treatment group1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital of Wenzhou Medical University
Lead sponsor
Xian-Janssen Pharmaceutical Ltd.
Collaborator
Source ClinicalTrials.gov