Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT03757533
Eligibility Criteria:
Inclusion Criteria:
* adult patients treated at the Inflammatory Bowel Disease (IBD) clinic at Vanderbilt with Crohn's disease or Ulcerative colitis confirmed by endoscopy or radiology assessment
* currently prescribed a biologic agent (self-injectable or infusion) for management of IBD
* medication dispensing is documented in patient medical record
Exclusion Criteria:
* patients less than 18 years of age
* unstable clinical condition (bleeding, infection, intestinal obstruction, etc.)
* patients who are required to get biologic medication at a specialty pharmacy outside of Vanderbilt University that is not documented in medical record(exclusion due to inability to accurately track prescription refills)
* patients with short bowel syndrome, an ostomy, obstructive disease with strictures, history of tuberculosis, hypersensitivity reaction to anti-TNF agent, cancer, renal failure requiring specific treatment such as dialysis
* patients with severe psychological comorbidity, defined as reported intent to self-harm or harm others or psychiatric hospitalization in the past year
* patients with current alcohol abuse or illegal drug use ascertained by medical history
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03757533
Study Brief:
Protocol Section:
NCT03757533