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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05161234
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 at time of consent
* Patient must meet the criteria for RA as defined by the 2010 ACR/EULAR classification at Visit 1
* Patient has active, moderate to high, RA with a CDAI of \>10 at Visit 1
* Patient has swollen and tender joint count of ≥ 2 each, as determined by CDAI assessment at Visit 1 using a 28-joint count
* Patient may participate in additional observational studies concurrently
* Patient is willing and able to complete the informed consent process and comply with study procedures and visit schedule
Exclusion Criteria:
* Patients who are unable to understand the protocol and unable to provide informed consent
* Patients who are not indicated for PrismRA
* Patients who are receiving concurrent treatment with an investigational therapy or have used an investigational therapy less than 4 weeks prior to Visit 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05161234
Study Brief:
Protocol Section:
NCT05161234