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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00254293
Eligibility Criteria:
Inclusion Criteria:
* Meet ARA criteria for diagnosis of RA with active disease.
* RA diagnosis for at least 1 year.
* \> = 6 swollen joints.
* \> = 8 tender joints.
* Taking methotrexate (MTX) or MTX plus not more than 1 added oral DMARD for \> = 3 months and stable for 28 days prior to dosing.
Exclusion Criteria:
* Serious acute or bacterial infection in last 3 months.
* Chronic or recurrent bacterial infections.
* History of TB within previous 3 years or old TB not adequately treated.
* Specific lab test abnormalities
* History of cancer within 5 years.
* Exposure to CTLA4Ig (Cytotoxic T-lymphocyte (T-cell)-associated antigen 4Ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
* Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
* Exposure to live vaccines.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00254293
Study Brief:
Protocol Section:
NCT00254293