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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT01299961
Eligibility Criteria:
Inclusion Criteria:
1. Over 18 years old
2. Has a diagnosis of rheumatoid arthritis
3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
4. Disease activity score DAS28/ESR \> 3.2 or all must be met: TJC (tender joint count)\>=4, SJC (swollen joint count)\>=4
5. Must be able to understand information in the Informed Consent and comply with study requirements
6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score \>=1 for at least 2 joints and total synovitis score \>=1 for at least 1 joint
Exclusion Criteria:
1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
2. Pregnancy or breast feeding
3. Daily prednisone \> 10mg (stable dose for at least 1 month)
4. Intra-articular steroid injection of the wrist or joints within last 2 months
5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
6. History of cancer
7. Previous exposure to abatacept
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01299961
Study Brief:
Protocol Section:
NCT01299961