Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis (GLOBE-SpA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases; Spondyloarthritis
• Intervention / Treatment: Drug: Guselkumab

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Nathasha Melukkaran; Phone Number: 646-754-3417; Email: Nathasha.melukkaran@nyulangone.org
• Study Contact Backup: Name: Peik Sean Chong; Phone Number: 646-754-3417; Email: Peiksean.chong@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

CD or UC patients initiating guselkumab.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Guselkumab intravenous or subcutaneous induction.; Other Names: Tremfya

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP)	ASDAS-CRP is a composite score that includes four patient's self-reported pain and stiffness questions, combined with C-reactive protein (CRP) levels, a marker of inflammation in the blood. The score helps assess how active the disease is and how well a treatment is working. The composite score categorizes patients as follows: <1.3: Inactive disease; ≥1.3 and <2.1: Moderate disease activity; ≥2.1 and <3.5: High disease activity; >3.5: Very high disease activity	Baseline, Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Janssen Scientific Affairs, LLC
• Investigators: Principal Investigator: David Hudesman, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2029

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Spinal Diseases; Gastroenteritis; Spondylitis; Spondylarthritis; Inflammatory Bowel Diseases; guselkumab
• Other Study ID Numbers: 25-01442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared only with funder (Janssen).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes