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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00482092
Eligibility Criteria:
Inclusion Criteria:
* failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic
* CDAI between 250 and 450, inclusive
* endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
* C-Reactive Protein Test (CRP) of at least 5 mg/l (0.5 mg/dl)\*OR\* CDAI of at least 300
* weight between 40 and 150 kg, inclusive
* adequate renal function
* negative tuberculosis skin (PPD) test (or evaluated low risk of TB activation)
Exclusion Criteria:
* HIV or hepatitis infection active
* allergy to CT contrast agents, or to bovine or porcine products
* symptomatic fibrostenotic Crohn's disease
* permanent ostomy
* biologic therapy within past 90 d
* prednisone greater than 20 mg/d within past month
* short-bowel syndrome
* total parenteral nutrition
* abnormal liver function
* malignancy active within past 5 years (except completely resected basal or squamous cell carcinoma of skin)
* enteric pathogens, including C. difficile
* history of colonic mucosal dysplasia
* current or prior evidence of tuberculosis (TB) (unless risk of activation or re-activation deemed low)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00482092
Study Brief:
Protocol Section:
NCT00482092