Cytokines and Genes in Therapeutic Response in Crohn's Disease
Public ClinicalTrials.gov record NCT03266471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03266471
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 96 participants
Conditions and interventions
Conditions
Interventions
- Baseline blood sample Diagnostic Test
- Baseline intestinal biopsies Diagnostic Test
- Crohn's disease activity index (CDAI) Other
- Post treatment blood sample Diagnostic Test
- Post treatment intestinal biopsies Diagnostic Test
- Baseline stool sample Diagnostic Test
- Post treatment stool sample Diagnostic Test
Diagnostic Test · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 12, 2017
- Primary completion
- May 2, 2022
- Completion
- May 2, 2022
- Last update posted
- Apr 13, 2023
2017 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Vanderbilt University Medical Center Endoscopy Laboratory | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03266471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2023 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03266471 live on ClinicalTrials.gov.