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NCT Number: NCT07602517

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.

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guselkumab

Drug

Guselkumab intravenous or subcutaneous induction.

Other names: Tremfya

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, Month 6

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nathasha Melukkaran

CONTACT

[email protected]

646-754-3417

Peik Sean Chong

CONTACT

[email protected]

646-754-3417

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

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

Acronym: GLOBE-SpA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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