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

Hoffmann-La Roche64 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Banská Bystrica, Slovakia

Unnamed facility

Bratislava, Slovakia

Unnamed facility

Košice, Slovakia

Unnamed facility

Piešťany, Slovakia

Outcomes

Primary Outcomes

Disease activity score (DAS28)

Time frame: 12 months

Secondary Outcomes

DAS 28 (subgroup on monotherapy)

Time frame: 12 months

DAS 28 (subgroup on 4 mg/kg dose)

Time frame: 12 months

Safety: Incidence of adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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