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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01578850
Eligibility Criteria:
Inclusion Criteria:
1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.
Exclusion Criteria:
1. Subjects who used any of the following systemic treatments during the washout periods given below:
1. Oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
2. Treatment with more than 1 NSAID within 14 days at baseline.
3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01578850
Study Brief:
Protocol Section:
NCT01578850