Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis

NCT07602517 | Not Yet Recruiting FDA Drug

• 1 other identifier: 25-01442
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spondyloarthritis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score

  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.

  Baseline, Month 6

Secondary Outcomes (1)

• Change in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP)

  Baseline, Month 6

Study Arms (1)

IBD Patients Initiating Guselkumab

Individuals with confirmed clinical SpA diagnosis who are initiating guselkumab as standard care for CD or UC will take surveys every 3 months over a 1-year timeframe.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab intravenous or subcutaneous induction.

Also known as: Tremfya

IBD Patients Initiating Guselkumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CD or UC patients initiating guselkumab.

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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Spondylarthritis; Inflammatory Bowel Diseases

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• David Hudesman, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathasha Melukkaran

CONTACT

646-754-3417; Nathasha.melukkaran@nyulangone.org

Peik Sean Chong

CONTACT

646-754-3417; Peiksean.chong@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)