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:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01545050
Eligibility Criteria:
Inclusion Criteria:
* Confirmed Crohn's Disease diagnosis via radiology, endoscopy or histology within prior 12 months. Diagnosed for at least 3 months
* Active Disease with Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450
* Failed conventional therapy or steroid dependent
Exclusion Criteria:
* Diagnosed/clinical findings of Ulcerative Colitis (UC), indeterminate colitis, non colonic/ileal disease
* Stricture/stenosis, Stoma, proctocolectomy, subtotal colectomy, ileorectal anastomosis
* History of diverticulitis, or evidence of Gastrointestinal (GI) perforations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01545050
Study Brief:
Protocol Section:
NCT01545050