A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
Recruiting
Observational Study
Inflamatory Bowel Disease
Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Observational
- Participants needed
- 60 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and ma…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-75 years.
* Diagnosis of Crohn's disease for at least 3 months.
* Moderate to severe disease activity (CDAI 220-450).
* Previous treatment with at least one standard dose of ustekinumab with documented:
* Primary non-response, or Secondary loss of response, or Intoleran…
Contacts