GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis
NYU Langone Health
Summary
This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis. This study will include adult patients aged 18-75 with IBD who are undergoing guselkumab intravenous or subcutaneous induction over a 1-year timeframe.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of Crohn's disease or Ulcerative Colitis disease based on confirmatory colonoscopy with biopsies, or if small bowel only, MRE with corresponding history * Age between 18 to 75 years old * Inflammatory bowel disease unclassified (IBD-U) subjects are eligible for inclusion if based on investigator assessment, the subject meets criteria for IBD-U, defined as chronic inflammatory bowel disease with overlapping features of Crohn's disease or ulcerative colitis * Initiating Guselkumab therapy in the next 30 days * Bio-naïve or bio-experienced\* to ≤3 mechan…
Interventions
- DrugGuselkumab
Guselkumab intravenous or subcutaneous induction.
Location
- NYU Langone HealthNew York, New York