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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01576367
Eligibility Criteria:
Inclusion criteria:
1. Patients who completed the core CACZ885D2307 study (a patient is defined as having completed the core study if they completed the study up to and including the EOS visit with no major protocol deviations in the core).
2. Male and female patients that are ≥ 1 year of age at the time of the roll-over visit.
3. Parent or legal guardian written informed consent must be obtained before any assessment in the extension CACZ885D2307E1 study is performed.
Exclusion criteria:
1. Patients for who continued treatment in the CACZ885D2307E1 extension study is not considered appropriate by the treating physician.
2. Patients who discontinued from the core CACZ885D2307 study
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
4 Years
Study:
NCT01576367
Study Brief:
Protocol Section:
NCT01576367