SpondyloarthritisGLOBE-SpANCT07602517
Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis
An observational study of Spondyloarthritis and Inflammatory Bowel Diseases, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spondyloarthritis, Inflammatory Bowel Diseases
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 20 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CD or UC patients initiating guselkumab.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Spondyloarthritis, Inflammatory Bowel Diseases
- Being tested
- Guselkumab
- Medical subject headings
- Spondylarthritis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called Tremfya
Guselkumab intravenous or subcutaneous induction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 May 2026 (estimated)
- Primary completion20 May 2028 (estimated)
- Study completion20 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- David Hudesman, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602517
- Sponsor's protocol ID
- 25-01442
- Acronym
- GLOBE-SpA
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared only with funder (Janssen).
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis
- ClinicalTrials.gov ID
- NCT07602517
- Acronym / sponsor ID
- GLOBE-SpA / 25-01442
- Conditions
- Spondyloarthritis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 May 2028 (estimated)
- Study completion
- 20 May 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD Patients Initiating Guselkumab | – | Drug: GuselkumabIndividuals 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CD or UC patients initiating guselkumab.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabAlso: TremfyaGuselkumab intravenous or subcutaneous induction. | Drug | IBD Patients Initiating Guselkumab |
Primary outcome
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.
1 secondary outcome
Change in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP)
Time frame: Baseline, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Data will be shared only with funder (Janssen).
Related trials for Spondyloarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Hudesman, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis and Inflammatory Bowel Diseases, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathasha Melukkaran (646-754-3417, Nathasha.melukkaran@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.