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This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day | Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glucocorticoid dose | Week 36 | |
| Change from baseline in corticosteroid dose | Week 36 | |
| Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitoria-Gasteiz | Alava | 01009 | Spain | |||
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| Week 36 |
| Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids | Week 36 |
| Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use | Week 36 |
| Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day | Week 36 |
| Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day | Week 36 |
| Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction | Week 36 |
| Percentage change in Disease Activity Score 28 (DAS28) | Week 36 |
| Percentage change in Simplified Disease Activity Index (SDAI) score | Week 36 |
| Safety: Incidence of adverse events | 36 weeks |
| Alicante |
| Alicante |
| 03700 |
| Spain |
| Elche | Alicante | 03203 | Spain |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Huesca | Huesca | 22004 | Spain |
| León | Leon | 24071 | Spain |
| Ponferrada | Leon | 24411 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Alzira | Valencia | 46600 | Spain |
| Valencia | Valencia | 46340 | Spain |
| Valencia | Valencia | 46520 | 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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