An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01388309

ML25524

Details and patient eligibility

About

This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.

Enrollment: 64 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
• Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion criteria

• Pregnant or lactating women
• Active infection
• Positive for hepatitis B, hepatitis C or HIV infection
• Concomitant anti-TNF drugs
• Contraindications to treatment with RoActemra/Actemra

Trial design

64 participants in 1 patient group

Cohort