Retrospective, Multi-center, Observational Study of Daily Practice Patterns and Outcomes of the Management of Rheumatoid Arthritis Patients Without Documented Erosions Treated With RoACTEMRA in Belgium

Hoffmann-La Roche0 sites77 target enrollmentAugust 2010

ConditionsRheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 77
Primary Endpoint: Joint erosion assessment in clinical practice
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

November 2010

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Joint erosion assessment in clinical practice

Time Frame: 6 months

Secondary Outcomes

Evolution of the pattern of joint erosion(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)
Tender joint counts(6 months)
Erythrocyte Sedimentation Rate(6 months)