An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patients≥ 18,

Have a documented diagnosis of moderate to severe CD

Have undergone an ileocolonic surgical resection

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Guselkumab

Treatment groups

88 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai 10th People's Hospital

Lead sponsor

Xian-Janssen Pharmaceutical Ltd.

Collaborator