Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis
Observational · No treatment assigned · 1 site · NYU Langone Health
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Spondyloarthritis and Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
Plus 2 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 75 participants are expected to take part.
- Start date: 2026-05-20 (planned).
- Main results expected around 2028-05-20 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (Baseline, Month 6)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Spondyloarthritis; Inflammatory Bowel Diseases |
| Lead sponsor | NYU Langone Health |
| Collaborators | Janssen Scientific Affairs, LLC |
| Enrollment | 75 (estimated) |
| Start date | 2026-05-20 |
| Primary completion (est.) | 2028-05-20 |
| First posted | 2026-05-22 |
| Last updated | 2026-05-22 |
| Official title | GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis |
| ClinicalTrials.gov ID | NCT07602517 |
Interventions
- Guselkumab (Drug)
Guselkumab intravenous or subcutaneous induction.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health | New York, New York | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.