A Retrospective, Observational Study of RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01921478
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This retrospective, multi-centre, observational study will assess the daily practice patterns and outcomes of the management of rheumatoid arthritis in patients treated with RoActemra/Actemra (tocilizumab). No actual patient will be enrolled in this study; data will be collected from medical records.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-08
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-09
• Last Update Submitted: 2013-08-09
• Study First Posted: 2013-08-13
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Adult patients, >=18 years of age
• Diagnosed with rheumatoid arthritis and moderate to severe disease activity defined as a DAS28 >=5.1
• Inadequate responder to at least 2 non-biological DMARDs
• Absence of documented erosions at start of RoActemra/Actemra treatment
• Received RoActemra/Actemra treatment for at least 6 months
• Availability of data from at least the RoActemra/Actemra treatment initiation visit and the 6 months visit

Exclusion Criteria

• Contraindications for treatment with RoActemra/Actemra

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Joint erosion assessment in clinical practice	6 months

Secondary Outcome Measures

Name	Time	Method
Tender joint counts	6 months
Disease Activity Score 28	6 months
Patient's global assessment of disease activity (Visual Analogue Scale)	6 months
C-reactive protein assessment	6 months
Swollen joint counts	6 months
Erythrocyte Sedimentation Rate	6 months
Evolution of the pattern of joint erosion	6 months