For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP postive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria.
For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP postive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria. 1. Patient has experienced failure to respond, documented intolerance, or contraindication to optimal use of one of the following disease modifying, anti-rheumatic (DMARD) regimens: A) i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide (20mg/day) for at least 3 months, in addition to iii) An adequate trial of at least one combination of DMARDs for 3 months; OR B) i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide in combination with methotrexate for at least 3 months; OR C) i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine 400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) 2. Patient has experienced failure to respond, documented intolerance, or contraindication to an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). 3. Patient is not using rituximab in a maintenance setting. 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab. 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of treatment is 1000mg followed two weeks later by the second 1000mg dose.