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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT05716334
Eligibility Criteria:
Inclusion Criteria:
Prospective cohort:
Initiated within the last 6 months:
1. RTX biosimilar or originator for induction OR
2. RTX biosimilar or originator for maintenance (with or without prior RTX induction) OR
3. Switched from RTX originator maintenance to biosimilar maintenance (4-12 months between infusions)
Historical cohort:
Followed in a prospective longitudinal cohort study/registry within the CanVasc network, and initiated the following after January 1, 2018 but \>6 months prior to study enrollment
1. RTX biosimilar or originator for induction OR
2. RTX biosimilar or originator for maintenance (with or without RTX induction)
Exclusion Criteria:
* patients without a diagnosis of GPA or MPA
* patients who did not/are not receiving RTX induction or maintenance therapy
* patients who initiated most recent RTX treatment course prior to Jan 1, 2018
* patients receiving RTX for reasons other than GPA or MPA induction or maintenance (e.g. other concurrent disease)
* unable to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05716334
Study Brief:
Protocol Section:
NCT05716334