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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT00845832
Eligibility Criteria:
Inclusion Criteria:
* adult patients, 18-65 years of age;
* rheumatoid arthritis, functional status I-III;
* SJC\>=4 (28 joint count) and TJC\>=4 (28 joint count) at screening and baseline;
* RF and/or anti-CCP positive;
* may have failed up to 1 approved anti-TNF agent (infliximab, etanercept or adalimumab);
* inadequate response to methotrexate, at a dose of 7.5-25mg weekly for at least 12 weeks, at a stable dose for past 4 weeks.
Exclusion Criteria:
* rheumatic autoimmune disease other than rheumatoid arthritis, or significant systemic involvement secondary to rheumatoid arthritis;
* history of, or current, inflammatory joint disease other than rheumatoid arthritis;
* diagnosis of juvenile idiopathic arthritis and/or rheumatoid arthritis before age 16;
* significant cardiac or pulmonary disease;
* previous treatment with any biologic agent for rheumatoid arthritis (other than infliximab, etanercept or adalimumab).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00845832
Study Brief:
Protocol Section:
NCT00845832