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.
Patients≥ 18，
Have a documented diagnosis of moderate to severe CD
Have undergone an ileocolonic surgical resection
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
The target population is male or female participants (minimum age 18) with a diagnosis of CD who have had a qualifying surgery (eg, ileocolonic resection) at most 3months before enrolled. Participants will be excluded if they have a short segment of bowel affected (ie,less than 10 cm) for fibrostenotic disease and they had their first surgery more than 10 years after diagnosis of CD. There is no requirement that participants have failed prior biologics.
Cohort
Prospective
Guselkumab
DrugGuselkumab 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 maintenance of remission is patients with moderate to severely active CD. No study is about the efficacy of IL-23is in POCD
Endoscopic recurrence rate at Wk 24
The primary objective of this study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of CD in participants after surgery
Clinical remission without recurrence at Wk24/Wk48
Clinical remission without recurrence (defined as CDAI \< 150) at Wk24/Wk48
Endoscopic recurrence at Wk48
Endoscopic recurrence at Wk48 (defined as modified Rutgeerts score ≥ i2b)
Endoscopic remission at Wk24/48
Endoscopic remission (defined as SES-CD≤3) at Wk24/48;
Safety profile
To explore the real-world safety profile of Guselkumab in this patient type
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Shanghai 10th People's Hospital
Lead sponsor
Xian-Janssen Pharmaceutical Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
