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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01388309
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-04
• Study First Posted: 2011-07-06
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease activity score (DAS28)	12 months

Secondary Outcome Measures

Name	Time	Method
DAS 28 (subgroup on monotherapy)	12 months
Safety: Incidence of adverse events	12 months
DAS 28 (subgroup on 4 mg/kg dose)	12 months