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Completed

NCT Number: NCT03266471

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, 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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center, Nashville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • pregnant
  • 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.

Treatment and study plan

Baseline blood sample

Diagnostic Test

Blood sample for cytokine measurements and genetics.

Baseline intestinal biopsies

Diagnostic Test

Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.

Crohn's disease activity index (CDAI)

Other

To determine response, a Crohn's Disease Activity Index (CDAI) score will be obtained at time point 1 and time point 2 in all enrolled CD patients. The CDAI is a well validated symptom index for CD which assesses 8 factors including stool frequency, abdominal pain, general well being, CD complications, HCT, and deviation from ideal body weight.

Post treatment blood sample

Diagnostic Test

Blood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks.

Post treatment intestinal biopsies

Diagnostic Test

Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy at least 6 weeks but no more than 52 weeks after initiation of therapy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.

Baseline stool sample

Diagnostic Test

Stool sample for inflammatory markers or microbiome analysis.

Post treatment stool sample

Diagnostic Test

Stool sample for inflammatory markers or microbiome analysis.

Primary outcomes

  1. 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

  1. Compare serum and tissue pro-inflammatory cytokines in CD patients and healthy subjects.

    Time frame: 26 weeks

    The investigators will compare serum and tissue cytokine/chemokine levels to see if Crohn's disease patients express a difference versus control.

  2. To assess whether gene variants are associated with treatment response.

    Time frame: 52 weeks

    The investigators will collect a one time whole blood sample from subjects starting a new anti-cytokine agent (infliximab, infliximab biosimilar, adalimumab, certolizumab, ustekinumab, or vedolizumab) and extract DNA and genotype. The investigators will look for associations between genotype and treatment response.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2017
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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