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Guselkumab for Inflammatory Bowel Disease and Spondyloarthritis

This study is looking at adults (ages 18-75) who have Crohn's disease or ulcerative colitis (types of inflammatory bowel disease, or IBD) and are starting treatment with guselkumab. Guselkumab is a medication given either through a vein (intravenous) or as a shot under the skin (subcutaneous). The researchers want to see if these patients develop new or existing spondyloarthritis, which is a type of arthritis that affects the spine and other joints. They will measure changes in a score called the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the beginning of the study and again after 6 months to see how the treatment affects symptoms. The study plans to include 75 participants.

Study design
This is an observational study, meaning researchers will watch a group of patients over time. It will include 75 adults with IBD who are starting guselkumab treatment.
What's involved
Participants will be followed for one year while receiving guselkumab. Their disease activity will be measured at the beginning and at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 6 months, but participants are followed for a 1-year timeframe.

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NCT07602517

Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis

Not Yet Recruiting
Not specifiedAges 18–75Observational
NYU Langone Health
~75 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Guselkumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Measured over Baseline, Month 6

Conditions

Spondyloarthritis
Inflammatory Bowel Diseases

Explore related trials

Crohn DiseaseInflammatory Bowel Disease UnclassifiedUlcerative Colitis

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • David Hudesman, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Nathasha Melukkaran
[email protected]
646-754-3417
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ScoreBaseline, Month 6

    BASDAI is a self-reported tool consisting of 6 questions evaluating fatigue, spinal pain, joint pain/swelling, areas of localized tenderness, and morning stiffness (duration and severity). Responses are on a 0-10 numeric rating scale; the final score is the average of responses and ranges from 0-10; higher scores indicate greater overall disease activity.