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 @ 3:19 PM
Ignite Modification Date:
2025-12-24 @ 3:19 PM
NCT ID:
NCT07242092
Eligibility Criteria:
Inclusion Criteria:
* Adults (\>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD).
* Stable MTX dose ≥12 weeks.
* Prednisone ≤5 mg/day.
* Low disease activity/remission according to specific disease activity criteria.
* Eligible for PCV20 vaccination (no prior PCV20).
Exclusion Criteria:
* Anaphylaxis to vaccine components.
* Acute febrile illness.
* Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease.
* Live vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before.
* Blood products in last 6 months.
* Severe infection in last month (including pneumococcal).
* Hospitalization at enrollment.
* Refusal to participate or inability to complete study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT07242092
Study Brief:
Protocol Section:
NCT07242092