Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNYU Langone Health
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Guselkumab
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
NYU Langone Health
Lead sponsor
Janssen Scientific Affairs, LLC
Collaborator
Source ClinicalTrials.gov