An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)

F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice

This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
• Inadequate clinical response to current treatment with >/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-TNF therapy
• Eligible for RoActemra/Actemra treatment in daily clinical practice
• Absence of evolutive tuberculosis (TB)

Exclusion Criteria:

• Hypersensitivity to tocilizumab or any of the excipients
• Active, severe infections
• Pregnant or lactating women
• Participation in any other interventional study
• Patients with major depression