An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guselkumab.
- Who it may be relevant to
- Registry conditions: Crohn's Disease (CD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.
Detailed description
This is an open-labeled, single arm, non-interventional, prospective, descriptive study, planned to include postoperative CD patients. After ileocolonic surgical resection, the patients who are treated with GUS will be enrolled in this study. The period is 48 weeks. The primary endpoint is Endoscopic recurrence （modified Rutgeerts score ≥ i2b）at Wk 24. IA is planned to be conducted when 30% of the enrolled patients have finished 24wk follow up. The Secondary endpoint are Clinical remission without recurrence（CDAI \< 150）at Wk24/Wk48;Endoscopic recurrence at Wk48 (modified Rutgeerts score ≥ i2b);Endoscopic remission（SES-CD≤3）at Wk24/48;Safety profile. Exploratory endpoint includes histologic score (Geboes scale/RHI/GHAS) at Wk24/48 ileocolonoscopy; time to endoscopic recurrence; time to recurrence of symptoms; endoscopic recurrence rate at Wk24/48(POCER)
Interventions
- Drug Guselkumab
Guselkumab is an IL23 p19 subunit antagonist that binds to IL-23 with high affinity and potency and also binds to the CD64 receptor (high affinity Fcγ receptor 1) on the surface of human inflammatory monocytes, which enables it to neutralize IL-23 at its predominant source of production, potentially enriching the presence of guselkumab in the inflamed tissue microenvironment.GALAXI and GRAVITI studies have demonstrated that Guselkumab treatment was both safe and effective for induction and maint
Primary outcome measures
- Endoscopic recurrence rate at Wk 24 [Time frame: From enrollment to Week 24]
Secondary outcome measures (4)
- Clinical remission without recurrence at Wk24/Wk48 [Time frame: From enrollment to Wk48]
- Endoscopic recurrence at Wk48 [Time frame: From enrollment to Wk48]
- Endoscopic remission at Wk24/48 [Time frame: From enrollment to Wk48]
- Safety profile [Time frame: From enrollment to Wk48]
Eligibility criteria
Inclusion criteria
- Patients≥ 18，
- Have a documented diagnosis of moderate to severe CD
- Have undergone an ileocolonic surgical resection
Exclusion criteria
- Has complications of CD, such as short bowel syndrome Currently has or is suspected to have an abscess
- Active infection
- Currently has a malignancy or has a history of malignancy within 5 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai 10th People's Hospital, Tongji University School of Medicine — Shanghai
Identifiers
NCT: NCT07528040 · SHSY-IEC-6.0/26K44/P01