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A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting

Study acronym: GLAMOUR
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
Trial Details
NCT Number NCT07851207
Lead Sponsor Janssen-Cilag Ltd.
Conditions Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov