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This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score (DAS28) | from baseline to Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ) | from baseline to Month 36 | |
| Measure of progressive joint destruction (vdHSS) | from baseline of U-Act-Early to Month 24 of U-Act-After |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who participated in the U Act Early study (ML22497)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands | |||
| Meander Medisch Centrum; Locatie Lichtenberg |
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| Changes in concomitant medication (especially tapering of corticosteroids) | from baseline to Months 36 |
| Sustained remission rates/drug-free remission rates | 36 months |
| Dose modifications/interruptions of RA treatment | 36 months |
| Safety: Incidence of adverse events, adverse events of special interest and serious adverse events | 36 months |
| Amersfoort |
| 3818 ES |
| Netherlands |
| Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde | Apeldoorn | 7334 DZ | Netherlands |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Rivas Zorggroep, Locatie Beatrixziekenhuis; Reumatologie | Gorinchem | 4204 AA | Netherlands |
| Groene Hart Ziekenhuis | Gouda | 2803 HH | Netherlands |
| Universitair Medisch Centrum Groningen; Department of Rheumatology | Groningen | 9700RB | Netherlands |
| Kennemer Gasthuis; Inwendige Geneeskunde | Haarlem | 2035RC | Netherlands |
| Atrium Medisch Centrum; Nephrology | Heerlen | 6419 PC | Netherlands |
| Tergooiziekenhuizen, loc. Hilversum | Hilversum | 1213 HX | Netherlands |
| Spaarne Ziekenhuis; Inwendige Geneeskunde | Hoofddorp | 2134 TM | Netherlands |
| Medisch Centrum Leeuwarden; Reumatology | Leeuwarden | 8934 AD | Netherlands |
| Academisch Ziekenhuis Leiden; Dept of Rheumatology | Leiden | 2333 ZA | Netherlands |
| Ijsselmeer Ziekenhuizen; Interne Geneeskunde | Lelystad | 8233 AA | Netherlands |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | 3430 EM | Netherlands |
| St. Maartenskliniek | Nijmegen | 6522 JV | Netherlands |
| Antonius Ziekenhuis Sneek; Department of Rheumatology | Sneek | 8601 ZK | Netherlands |
| University Medical Centre Utrecht; Reumatologie en Klinische Immunologie | Utrecht | 3584 GA | Netherlands |
| Maartenskliniek Woerden | Woerden | 3447 GN | 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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