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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT07052032
Eligibility Criteria:
Inclusion Criteria:
1. 18 to 75 years old
2. Diagnosis of adult-onset RA
3. Class I-III RA
4. Moderately to severely active RA
5. Inadequate treatment response as defined in the protocol
6. Stable use of any concomitant therapies
Exclusion Criteria:
1. Inadequate clinical laboratory parameters at Screening
2. Active infection
3. Receipt of or inability to discontinue any excluded therapies
4. Receipt of live vaccine within 4 weeks
5. Presence of any concomitant autoimmune disease
6. Active or known history of catastrophic anti-phospholipid syndrome
7. APS or thrombotic event not adequately controlled by anticoagulation therapy
8. History of progressive multifocal leukoencephalopathy
9. Central nervous system disease
10. Presence of 1 or more significant concurrent medical conditions
11. Have a diagnosis or history of malignant disease within 5 years
12. Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair ability to receive planned treatment or to understand informed consent
13. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
14. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
15. Women who are pregnant or breastfeeding
16. Patients who do not agree to the use of highly effective contraception as defined by the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07052032
Study Brief:
Protocol Section:
NCT07052032