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This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 12 months | |
| Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI) | 12 months | |
| Response rate according to EULAR (European League Against Rheumatism) criteria |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra after at least one previous DMARD or TNF-inhibitor treatment
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coral Springs | Florida | 29010 | United States | |||
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| 12 months |
| Quality of life (Visual Analogue Scales, Health Assessment Questionnaire) | 12 months |
| Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors | 12 months |
| Effect on DMARD tolerance/dosage in combination therapy | 12 months |
| Dosages used in clinical practice | 12 months |
| Elche |
| Alicante |
| 03203 |
| Spain |
| Elda | Alicante | 03600 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Sant Joan Despí | Barcelona | 08970 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Torrelavega | Cantabria | 39300 | Spain |
| Castellon | Castellon | 12004 | Spain |
| Vinaròs | Castellon | 12500 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Girona | Girona | 17002 | Spain |
| Granada | Granada | 18003 | Spain |
| Granada | Granada | 18014 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Huelva | Huelva | 21005 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Logroño | La Rioja | 26006 | Spain |
| Alcalá de Henares | Madrid | 28805 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| El Escorial | Madrid | 28200 | Spain |
| Madrid | Madrid | 28006 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Madrid | Madrid | 28905 | Spain |
| Madrid | Madrid | 28935 | Spain |
| Málaga | Malaga | 29009 | Spain |
| Cartagena | Murcia | 30203 | Spain |
| El Palmar | Murcia | 30120 | Spain |
| Lorca | Murcia | 30800 | Spain |
| Murcia | Murcia | 30008 | Spain |
| Pamplona | Navarre | 31008 | Spain |
| Ourense | Orense | 32005 | Spain |
| Vigo | Pontevedra | 36204 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Toledo | Toledo | 45004 | Spain |
| Alzira | Valencia | 46600 | Spain |
| San Juan | Valencia | 03550 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Valencia | Valencia | 46015 | Spain |
| Valencia | Valencia | 46017 | Spain |
| Valenica | Valencia | 46009 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Bilbao | Vizcaya | 48013 | Spain |
| 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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