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A Multicenter, Prospective, Observational Study: Evaluating the Efficacy and Safety of Guselkumab in Preventing Endoscopic Recurrence in Postoperative Crohn's Disease Patients

A Multicenter, Prospective, Observational Study: Evaluating the Efficacy and Safety of Guselkumab in Preventing Endoscopic Recurrence in Postoperative Crohn's Disease Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123613
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Patients diagnosed with moderate to severe Crohn's disease (CD) according to the European Crohn's and Colitis Organisation (ECCO) guidelines; 3. History of ileocolonic resection; 4. Treatment with guselkumab postoperatively.

Exclusion criteria

Exclusion criteria: 1. Patients with fibrostenotic lesions and a short affected intestinal segment (<10 cm) who underwent their first surgery more than 10 years after the diagnosis of CD; 2. Patients with CD complications, such as existing or suspected abscesses; 3. Patients with active infections, including but not limited to active tuberculosis; 4. Patients with existing malignant tumors or a history of malignancy within the past 5 years; 5. Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
Endoscopic recurrence;

Secondary

MeasureTime frame
Clinical Remission;Safety;Histological Score;

Countries

China

Contacts

Public ContactXiaolei Wang

Shanghai Tenth People's Hospital

xlwang2006@163.com+86 138 1726 7967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026