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Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis

ConditionsSpondyloarthritisInflammatory Bowel Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial population

CD or UC patients initiating guselkumab.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Guselkumab

    Drug

    Guselkumab intravenous or subcutaneous induction.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: IBD Patients Initiating Guselkumab1 intervention

Trial outcomes

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.

Time frame
Baseline, Month 6

Secondary outcomes

1

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

Time frame
Baseline, Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Janssen Scientific Affairs, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: