Crohn's Disease (CD)
Conditions
Keywords
IBD
Brief summary
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
DRUGGuselkumab
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 maintenance of remission is patients with moderate to severely active CD. No study is about the efficacy of IL-23is in POCD
Sponsors
Shanghai 10th People's Hospital
Xian-Janssen Pharmaceutical Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic recurrence rate at Wk 24 | From enrollment to Week 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission without recurrence at Wk24/Wk48 | From enrollment to Wk48 | Clinical remission without recurrence (defined as CDAI \< 150) at Wk24/Wk48 |
| Endoscopic recurrence at Wk48 | From enrollment to Wk48 | Endoscopic recurrence at Wk48 (defined as modified Rutgeerts score ≥ i2b) |
| Endoscopic remission at Wk24/48 | From enrollment to Wk48 | Endoscopic remission (defined as SES-CD≤3) at Wk24/48; |
| Safety profile | From enrollment to Wk48 | To explore the real-world safety profile of Guselkumab in this patient type |
Countries
China
Contacts
CONTACTXiaolei Wang
Outcome results
None listed