A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Inclusion Criteria:

• adult patients >/= 18 years of age
• moderate to severe active rheumatoid arthritis
• inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
• DAS >3.6
• pneumology examination (including chest x-ray and quantiferon)

Exclusion Criteria:

• < 18 years of age
• active infection
• active tuberculosis
• uncontrolled hyperlipoproteinaemia
• demyelinating disorders
• concomitant anti-TNF drugs
• history of intestinal ulceration and diverticulitis