- The patient has a diagnosis of RA based upon the American College of Rheumatology
(ACR) 1987 Revised Criteria.
- The patient must have had an inadequate response to methotrexate and have active
disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints
swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren
method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
- No evidence of active or latent or inadequately treated infection with Mycobacterium
- The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate
and washed out of all other DMARDs.
- Blood dyscrasias including confirmed: 1. Hemoglobin White blood cell count Platelet count
- History of any other autoimmune rheumatic disease other than Sjogren's syndrome
- No malignancy or history of malignancy.
- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug
- Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism
related adverse event.
- Patients who have previously received adalimumab therapy for any reason.
- Patients who are contraindicated for treatment with adalimumab in accordance with the
approved local label.
- Patients meeting the New York Heart Association Class III and Class IV Congestive