Inflammatory Bowel Diseases, Spondyloarthritis
Conditions
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.
Interventions
DRUGGuselkumab
Guselkumab intravenous or subcutaneous induction.
Sponsors
NYU Langone Health
Janssen Scientific Affairs, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP) | 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 |
Countries
United States
Contacts
CONTACTNathasha Melukkaran
CONTACTPeik Sean Chong
PRINCIPAL_INVESTIGATORDavid Hudesman, MD
NYU Langone Health
Outcome results
None listed