Eligibility Module

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 @ 5:48 PM
Ignite Modification Date: 2025-12-24 @ 5:48 PM
NCT ID: NCT00508768
Eligibility Criteria: Inclusion Criteria: * Patients with active rheumatoid arthritis * Patients on methotrexate are required to have taken a stable methotrexate dose of 15 to 25 mg/week (or lower maximum-tolerated dose level) for at least 1 month before study entry * Patients with no methotrexate are required to have taken no methotrexate for at least 1 month before study entry * Non steroidal anti inflammatory drugs (NSAIDs) and low-dose prednisone are allowed if doses had been stable for at least 1 month before study entry * Patients of childbearing potential must have agreed to practice two forms of birth control for the duration of the trial. Exclusion Criteria: * Have taken infliximab or experimental biological antagonists (e.g., TNF antagonists) within the 3-month period before study entry * Have used leflunomide within the 3 month period before study entry * Have taken etanercept, anakinra, and disease-modifying anti-rheumatic drugs (DMARDs) other than leflunomide (and methotrexate) within the 4-week period before study entry * Received intra-articular, intramuscular, or intravenous (IV) doses of corticosteroids or received oral doses of corticosteroids exceeding 10 mg/day within the 4-week period before study entry * Elevated levels (greater than 1.2 times the upper limit of normal) of aspartate transaminase or alanine transaminase within the 6-month period before study entry.
Healthy Volunteers: False
Sex: FEMALE
Minimum Age: 18 Years
Study: NCT00508768
Study Brief:
Protocol Section: NCT00508768