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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00538902
Eligibility Criteria:
Inclusion Criteria:
* Met ACR criteria for diagnosis of active rheumatoid arthritis (RA) and have had at both the Screening visit and Week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed)
* Subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (DMARDs)
* DMARDs (other than methotrexate \[MTX\]) must have been discontinued for \>= 28 days or at least 5 half-lives, whichever is greater, before the Week 0 visit
* Traditional Chinese Medicines must have been discontinued for \>= 28 days before the Week 0 visit
* Subjects must have received at least three months of treatment with MTX (minimum 7.5 mg/week) and remained on a stable dose of MTX for \>= 28 days prior to the Screening visit
* Glucocorticoids equivalent to \<= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the Week 0 visit
* Must have been able and willing to give written informed consent and to comply with the requirements of this study protocol
Exclusion Criteria:
* A history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
* Wheelchair-bound or bedridden
* Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit
* Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit
* Prior treatment with any TNF antagonist, including adalimumab
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00538902
Study Brief:
Protocol Section:
NCT00538902