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This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to DAS28 remission | 5 years | |
| Proportion of patients with good or moderate response according to EULAR criteria | 5 years | |
| Time to good or moderate response according to EULAR criteria |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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Patients with inadequate response or intolerant to DMARDs and anti-TNF
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osnabrück | 49074 | Germany |
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| 5 years |
| Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness) | 5 years |
| Dose-modifications and discontinuations of RoActemra/Actemra | 5 years |
| Safety: Incidence of adverse events | 5 years |
| Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria) | 5 years |
| Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events) | 5 years |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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