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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01540292
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years old
* Crohn's disease affecting terminal ileum, colon or both with diagnosis confirmed according to Lennard Jones criteria
* Clinically active disease with a CDAI between 220 and 450 and biologically active disease with a CRP \> 5 mg/l and/or fecal calprotectin \> 150 microg/g
* Resistance or intolerance to mesalazine, steroids, purine analogues, methotrexate, infliximab and adalimumab
* Adequate venous access (central catheter or good peripheral veins)
* Willingness to sign the informed consent and enter the clinical trial
Exclusion Criteria:
* Any condition not fulfilling inclusion criteria
* Indication for surgery
* Symptomatic stricture
* Undrained perianal or intraabdominal abscess
* Change in mesalazine dosage within the last 4 weeks, change in steroid dosage within the last two weeks, change in immunosuppressant dosage within the last 3 months, use of anti-TNF treatment within the last two months
* HIV positive
* Uncontrolled infection, arrhythmia or hypertension
* Terminal organ failure:
* Renal: anuria, serious fluid overload, GFR \< 30 ml/min, dialysis;
* Pulmonary: DLCO \< 35% and/or receiving supplementary continuous oxygen;
* Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL, and symptomatic biliary disease;
* Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction \< 35%; uncontrolled arrhythmia, uncontrolled hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01540292
Study Brief:
Protocol Section:
NCT01540292