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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01921478

Enrollment

Registered

2013-08-13

Start date

2010-08-31

Completion date

2010-11-30

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Joint erosion assessment in clinical practice	6 months

Secondary

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

Countries

Belgium

Outcome results