Cytokines and Genes in Therapeutic Response in Crohn's Disease

Completed

Conditions studied: Inflammatory Bowel Diseases

In brief

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.

Key facts

Study ID

NCT03266471

Run by

Vanderbilt University Medical Center

People needed

96

Starts

2017-10-13

Expected to finish

2022-05-03

Last updated by the study team

2023-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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