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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00771667
Eligibility Criteria:
Inclusion Criteria:
* Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
* Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease
* Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease
* Must be 18 years of age or older
* Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI \> =220 and \< =450).
Exclusion Criteria:
* Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months
* Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent
* Patients who have received Remicade, Humira or Cimzia \< =8 weeks before the first administration of study drug
* Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
* Patients with a history of or ongoing chronic or recurrent infectious disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00771667
Study Brief:
Protocol Section:
NCT00771667