Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis
Starting soon
Conditions studied: Spondyloarthritis, Inflammatory Bowel Diseases
In brief
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.
Key facts
- Study ID
- NCT07602517
- Run by
- NYU Langone Health
- People needed
- 75
- Starts
- 2026-05-20
- Expected to finish
- 2029-05-20
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 mechanisms of action *Defined as prior exposure or failure, as defined by inadequate efficacy or intolerance
You may not qualify if…
- Unable to provide consent for participation
- Known SpA diagnosis, prior to screening
- Has started Guselkumab therapy
- Prior exposure to IL-23 therapy (like Mirikizumab, Ustekinumab, etc.)
- Prior exposure to TB, active or currently undergoing treatment for latent TB
- Pregnancy as some pregnancy symptoms could be mistaken for SpA symptoms
- Prior exposure to combination advanced biologic therapies
Where it is running
- NYU Langone Health — New York, New York, United States
Full record on ClinicalTrials.gov
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