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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT00805766
Eligibility Criteria:
Inclusion Criteria:
* Patients with Crohn's disease
* Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician
Exclusion Criteria:
* Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery
* The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed
* A history of a serious infusion reaction to REMICADE
* Pregnant, lactating, and probably pregnant women
* Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent
* Patients judged to be inadequate to participate in this study by their physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT00805766
Study Brief:
Protocol Section:
NCT00805766