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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01667458

ML25702

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

59 participants in 1 patient group

Cohort