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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00195702
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits \>=6 swollen joints and \>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints \[DIPs\] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \[DMARDs\] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)
* Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).
* If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
* Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
* Both rheumatoid factor positivity and a C-reactive protein value \>=1 mg/dL, or at least one joint erosion on X-ray.
Exclusion Criteria:
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
* Female subject who was pregnant or breast-feeding or considering becoming pregnant.
* Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
* Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
* Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
* Subject was wheelchair bound or bedridden.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00195702
Study Brief:
Protocol Section:
NCT00195702