Guselkumab to Prevent Crohn's Disease Returning After Bowel Surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe Crohn's disease who have had surgery to remove part of the bowel (ileocolonic resection). It studies guselkumab to prevent the disease from coming back.

Age

18 years or older

Sex

All sexes can join

Disease stage

Documented moderate to severe Crohn's disease

Earlier treatment

Must have had an ileocolonic surgical resection (surgery removing part of the bowel)

Main reasons for not taking part

• Complications of Crohn's disease, such as short bowel syndrome
• Current or suspected abscess
• Active infection
• Current cancer or cancer within the past 5 years

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• 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.

  Treatment: Guselkumab