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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT05955066
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 year-old,
2. fulfilment of the 2010 ACR/EULAR classification criteria of RA,
3. on MTX for at least 12 weeks, and
4. disease activity score 28-C-reactive protein (DAS28-CRP) \> 3.2.
Exclusion Criteria:
1. ≥65 years old,
2. functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities);
3. pregnancy or premenopausal women planning pregnancy;
4. ever use of any b/tsDMARDs or csDMARDs other than methotrexate and hydroxychloroquine for RA;
5. ever use of bisphosphonates, denosumab or teriparatide;
6. history of cardiovascular disease/thrombo-embolism/malignancy;
7. contraindications to baricitinib; and
8. severe joint damage in MCP2-4 which preludes HR-pqCT measurement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05955066
Study Brief:
Protocol Section:
NCT05955066