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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00655135
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent.
* Crohn's disease of at least 6 months' duration.
* Endoscopic and/or histopathological and/or radiological documentation consistent with Crohn's disease obtained preferably within 24 months of screening.
* Crohn's disease involving the colon and/or the ileum.
* CDAI score from 220 to 400 (inclusive) at the time of the Screening visit. The CDAI must have remained between 220 and 400 after the 1-week Screening period for the patient to be eligible.
* Patients may have been receiving oral or topical 5-ASA compounds provided the dosage had been stable for at least the 14-day period before the Screening visit. Patients were to be maintained on the 5-ASA compound at a constant dose at least through Day 57.
Exclusion Criteria:
* Patients with evidence of current GI infection (bacterial or parasitic) or significant infection within 45 days of the screening visit.
* Patients with a serious underlying disease other than Crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia.
* Patients with significantly impaired liver or renal function. This includes those with established chronic liver disease including hepatitis B or C.
* Patients with the laboratory abnormalities
* Patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures.
* Patients with active psychiatric problems which, in the investigator's opinion, may interfere with compliance with the study procedures.
* Patients who have previously received or who are currently receiving treatment with a monoclonal antibody.
* Patients receiving any investigational therapy, excluded medications as defined in protocol, or any approved therapy in an investigational protocol within 30 days prior to screening.
* Patients unable to attend all the study visits or comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00655135
Study Brief:
Protocol Section:
NCT00655135