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This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice | approximately 1 year | |
| Type of biological agents used in monotherapy in routine clinical practice | approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores | approximately 1 year | |
| Quality of life: HAQ-DI score | approximately 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rheumatoid arthritis who are currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | 9300 | Belgium | ||||
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| Safety of biologics used in monotherapy: Incidence of adverse events | approximately 1 year |
| Brussels |
| 1070 |
| Belgium |
| Edegem | 2650 | Belgium |
| Genk | 3600 | Belgium |
| Ghent | 9000 | Belgium |
| Haine-Saint-Paul | 7100 | Belgium |
| Kortrijk | 8500 | Belgium |
| Liège | 4000 | Belgium |
| Merksem | 2170 | Belgium |
| Mons | 7000 | Belgium |
| Seraing | 4100 | Belgium |
| Turnhout | 2300 | Belgium |
| Verviers | 4800 | Belgium |
| Westmalle | 2390 | Belgium |
| 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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