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This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment | Up to 31 months (24 months each patient) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients with at least one severe adverse event (SAE) | Up to 31 months (24 months each patient) | |
| Percent of patients who discontinued therapy with RTX | Up to 31 months (24 months each patient) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pescara | Abruzzo | 65100 | Italy | |||
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| Time to "re-treatment" with RTX | Up to 31 months (24 months each patient) |
| Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs | Up to 31 months (24 months each patient) |
| Time to response and duration of response to RTX | Up to 31 months (24 months each patient) |
| Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline | Up to 31 months (24 months each patient) |
| Brindisi |
| Apulia |
| 72100 |
| Italy |
| Martina Franca | Apulia | 74015 | Italy |
| San Cesario di Lecce | Apulia | 73016 | Italy |
| San Daniele Del Friuli | Apulia | 33038 | Italy |
| Mormanno | Calabria | 87026 | Italy |
| Naples | Campania | 80131 | Italy |
| Naples | Campania | 80144 | Italy |
| Scafati | Campania | 84018 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Parma | Emilia-Romagna | 43100 | Italy |
| Piacenza | Emilia-Romagna | 29100 | Italy |
| Gorizia | Friuli Venezia Giulia | 34170 | Italy |
| Trieste | Friuli Venezia Giulia | 34142 | Italy |
| Albano Laziale | Lazio | 00041 | Italy |
| Rieti | Lazio | 02100 | Italy |
| Rome | Lazio | 00128 | Italy |
| Rome | Lazio | 00133 | Italy |
| Rome | Lazio | 00135 | Italy |
| Rome | Lazio | 00152 | Italy |
| Rome | Lazio | 00153 | Italy |
| Rome | Lazio | 00189 | Italy |
| Viterbo | Lazio | 01100 | Italy |
| Arenzano | Liguria | 16011 | Italy |
| Savona | Liguria | 17100 | Italy |
| Cremona | Lombardy | 26100 | Italy |
| Legnano | Lombardy | 20025 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20161 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Monza | Lombardy | 20052 | Italy |
| Rozzano | Lombardy | 20089 | Italy |
| Cuneo | Piedmont | 12100 | Italy |
| Novara | Piedmont | 28100 | Italy |
| Pinerolo | Piedmont | 10064 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Turin | Piedmont | 10128 | Italy |
| Cagliari | Sardinia | 09042 | Italy |
| Monserrato | Sardinia | 09042 | Italy |
| Catania | Sicily | 95124 | Italy |
| Catania | Sicily | 95126 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Palermo | Sicily | 90146 | Italy |
| Arezzo | Tuscany | 52100 | Italy |
| Florence | Tuscany | 50100 | Italy |
| Massa | Tuscany | 54100 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Pontedera | Tuscany | 56025 | Italy |
| Prato | Tuscany | 59100 | Italy |
| Treviso | Veneto | 31100 | Italy |
| Valeggio sul Mincio | Veneto | 37067 | Italy |
| Venezia | Veneto | 30127 | Italy |
| Verona | Veneto | 37134 | Italy |
| Vicenza | Veneto | 36100 | Italy |
| 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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