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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00988832
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Crohn's Disease.
* Over the age of 18 years.
* Must have received the first infusion of infliximab on or after 1st January 2003 (when the maintenance therapy license was granted).
* Must have received at least one infusion of infliximab.
* A minimum of 12 months data prior to, and 24 months data post infliximab exposure should be available in the medical records.
* Must have been under the care of the participating center for the entirety of the study period.
Exclusion Criteria:
* Should not have been involved in any clinical trial during the observational period (ie, a minimum of 12 months before and 24 months after first receiving infliximab).
* Should not have received any biologic therapy prior to infliximab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00988832
Study Brief:
Protocol Section:
NCT00988832