(i) ESR ≥ 25 mm/hr and/or CRP ≥ 15 mg/L, (ii) a total active joint count of at least 20 active (swollen and tender) joints, or (iii) at least 4 active joints from the following list of major joints: (a) elbow, wrist, knee, and/or ankle (assessed as swollen and tender) and/or (b) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth) |
(i) currently taking methotrexate at a dose of ≥7.5 mg/week (infliximab and anakinra only), (ii) failed to achieve an adequate response to methotrexate at a dose of ≥20 mg/week, (iii) failed to achieve an adequate response to methotrexate (≥7.5 mg/week) with 2 other DMARDs at approved doses, (iv) failed to achieve an adequate response following a minimum of 3 months treatment with Leflunomide alone, or Leflunomide with methotrexate, or Cyclosporin alone |