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Not yet recruiting NCT07602517

Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis

— Observational Spondyloarthritis Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guselkumab.
Who it may be relevant to
Registry conditions: Spondyloarthritis, Inflammatory Bowel Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis

Overview

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.

Interventions

  • Drug Guselkumab
    Guselkumab intravenous or subcutaneous induction.

Primary outcome measures

  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score [Time frame: Baseline, Month 6]
Secondary outcome measures (1)
  • Change in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP) [Time frame: Baseline, Month 6]

Eligibility criteria

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 mechanisms of action \*Defined as prior exposure or failure, as defined by inadequate efficacy or intolerance

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07602517 · 25-01442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗