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This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity score (DAS 28) | baseline and up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disability, assessed by Health Assessment Questionnaire (HAQ) | baseline and up to 4 years | |
| Change in concomitant medication (especially tapering of steroids) | baseline and up to 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in the ACT SURE clinical trial or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Van Breemen Instituut | Amsterdam | 1056 AB | Netherlands | |||
| Gelre Ziekenhuis; Reumatology |
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| Change in dosage schedule (modification/interruption/discontinuation) | baseline and up to 4 years |
| Safety: Incidence of adverse events | up to 4 years |
| Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness) | up to 4 years |
| Apeldoorn |
| 7300 DS |
| Netherlands |
| Rijnstate Ziekenhuis; Afdeling Reumatologie | Arnhem | 6815 AD | Netherlands |
| Amphia ziekenhuis, locatie langendijk | Breda | 4819 EV | Netherlands |
| Deventer ziekenhuis | Deventer | 7416 SE | Netherlands |
| MC groep - locatie Emmeloord | Emmeloord | 8300 GA | Netherlands |
| Scheper Ziekenhuis | Emmen | 7824 AA | Netherlands |
| Medisch Centrum Twente; Rheumatology | Enschede | 7511 JX | Netherlands |
| Ziekenhuis Walcheren; Reumatologie | Flushing | 4382 EE | Netherlands |
| Groene Hart Ziekenhuis | Gouda | 2803 HH | Netherlands |
| Röpcke Zweers ziekenhuis; Reumatologie | Hardenberg | 7772 SE | Netherlands |
| Tergooiziekenhuizen, loc. Hilversum | Hilversum | 1213 HX | Netherlands |
| Medisch Centrum Leeuwarden; Reumatology | Leeuwarden | 8934 AD | Netherlands |
| Maastricht University Medical Centre; Rheumatology | Maastricht | 6202 ZA | Netherlands |
| St. Antonius Ziekenhuis; Pharmacy | Nieuwegein | 3435 CM | Netherlands |
| St. Maartenskliniek | Nijmegen | 6522 JV | Netherlands |
| Maasstadziekenhuis; Reumatologie | Rotterdam | 3079 DZ | Netherlands |
| Vlietland Hospital | Schiedam | 3118 JH | Netherlands |
| Leyenburg Ziekenhuis; Internal Medecine | The Hague | 2545 CH | Netherlands |
| 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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