Rheumatoid Arthritis Clinical Trial
Official title:
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
Verified date | August 2013 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Independent Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Joint erosion assessment in clinical practice | 6 months | No | |
Secondary | Disease Activity Score 28 | 6 months | No | |
Secondary | C-reactive protein assessment | 6 months | No | |
Secondary | Swollen joint counts | 6 months | No | |
Secondary | Tender joint counts | 6 months | No | |
Secondary | Erythrocyte Sedimentation Rate | 6 months | No | |
Secondary | Evolution of the pattern of joint erosion | 6 months | No | |
Secondary | Patient's global assessment of disease activity (Visual Analogue Scale) | 6 months | No |
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