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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02820493
Eligibility Criteria:
Inclusion Criteria:
* Have given written informed consent to participate
* Be aged between 18 and 80
* Have a moderate/severe CD defined by an HBI \>7 CD
Exclusion Criteria:
* previous treatment with anti-TNF drugs,
* concomitant use of immune-modulator drugs for CD (azathioprine/6-mercaptopurine, methotrexate)
* ulcerative colitis (UC) or inflammatory bowel disease undetermined (IBD-U) diagnosis
* symptomatic obstructive disease
* bowel resection within the past 6 months
* ileostomy
* extensive small bowel resection (as determined by the investigator) or a short bowel syndrome
* patients who are currently receiving total parenteral nutrition
* history of cancer in the past 5 years
* pregnancy known at the study inclusion
* positive Clostridium difficile stool assay
* Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02820493
Study Brief:
Protocol Section:
NCT02820493