Cytokines and Genes in Therapeutic Response in Crohn's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Compare longitudinal cytokine measurements in treatment responders versus nonresponders.
Study Overview
Brief Summary
Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis (UC), affects more than 1.6 million people in the United States alone. Though the precise mechanisms underlying the inflammation and immune responses in IBD are still being investigated, various inflammatory mediators, including pro-inflammatory cytokines, and genes have been implicated in the disease process. At present, there are no reliable mechanisms to predict response to individual IBD medications. The investigators seek to evaluate whether inflammatory cytokines change longitudinally during treatment with anti-cytokine agents in both treatment primary responders and primary non-responders. In addition, the investigators will be evaluating the pharmacogenetics of treatment response to these agents.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients that are seen in the Inflammatory Bowel Disease clinic with Crohn's disease who are initiating either treatment as part of their routine clinical care.
- •Healthy adults without IBD undergoing colonoscopy for colorectal cancer screening or other non-IBD related indication.
Exclusion Criteria
- •have a known coagulopathy or bleeding disorder
- •have known renal or hepatic impairment
- •have a history of organ transplantation
- •CD patients who are being seen in consultation and do not plan to receive longitudinal care through initiation their new therapy at the Vanderbilt IBD center will be excluded.
Outcomes
Primary Outcomes
Compare longitudinal cytokine measurements in treatment responders versus nonresponders.
Time Frame: 52 weeks
The investigators will classify Crohn's disease subjects as primary responders or primary non-responders to anti-TNF-α, ustekinumab, or vedolizumab therapy based on clinical, endoscopic, and/or histologic data. The investigators will compare serum and tissue cytokines in CD subjects at before and after treatment initiation.
Secondary Outcomes
- Compare serum and tissue pro-inflammatory cytokines in CD patients and healthy subjects.(26 weeks)
- To assess whether gene variants are associated with treatment response.(52 weeks)
Investigators
Elizabeth Scoville
Principal Investigator
Vanderbilt University Medical Center