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| Name | Class |
|---|---|
| Xian-Janssen Pharmaceutical Ltd. | INDUSTRY |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gulselkumab after surgery | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission without recurrence at Wk24/Wk48 | Clinical remission without recurrence (defined as CDAI < 150) at Wk24/Wk48 | From enrollment to Wk48 |
| Endoscopic recurrence at Wk48 | Endoscopic recurrence at Wk48 (defined as modified Rutgeerts score ≥ i2b) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolei Wang | Contact | +86 13817267967 | xlwang2006@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 10th People's Hospital, Tongji University School of Medicine | Shanghai | China |
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| From enrollment to Wk48 |
| Endoscopic remission at Wk24/48 | Endoscopic remission (defined as SES-CD≤3) at Wk24/48; | From enrollment to Wk48 |
| Safety profile | To explore the real-world safety profile of Guselkumab in this patient type | From enrollment to Wk48 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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