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Cytokines and Genes in Therapeutic Response in Crohn's Disease

NCT03266471 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DIAGNOSTIC_TEST Baseline blood sample
  • DIAGNOSTIC_TEST Baseline intestinal biopsies
  • OTHER Crohn's disease activity index (CDAI)
  • DIAGNOSTIC_TEST Post treatment blood sample
  • DIAGNOSTIC_TEST Post treatment intestinal biopsies

Study Locations (2)

Tennessee

  • Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center — Nashville
  • Vanderbilt University Medical Center Endoscopy Laboratory — Nashville

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2017-10-13
Est. Completion 2022-05-03

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03266471

The ClinicalTrials.gov registry entry for NCT03266471 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Inflammatory Bowel Diseases appearing as the primary indexed condition, and to 5 interventions — of which Baseline blood sample is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03266471 reports 2 study locations spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03266471 about?

NCT03266471 is a clinical study titled "Cytokines and Genes in Therapeutic Response in Crohn's Disease". 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, vari...

What is the current status of trial NCT03266471?

This trial is currently completed. The enrollment target is 96 participants. The study started on 2017-10-13. Estimated completion is 2022-05-03.

What conditions does trial NCT03266471 study?

This clinical trial studies the following conditions: Inflammatory Bowel Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03266471?

The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03266471?

This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03266471 being conducted?

This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial