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This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | Rituximab use in non-oncology indications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab | Up to 10 months | |
| Percentage of Participants Using Rituximab Off-Label | Up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA) | Up to 10 months | |
| Percentage of Participants Who Received the Patient Alert Card (PAC) | Up to 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in the center to receive an infusion for rituximab for a non-oncology indication during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu De Clermont Ferrand; Hopital Gabriel Montpied | Clermont-Ferrand | 63003 | France | |||
| Centre Hospitalier Sud Francilien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31911839 | Derived | Sarsour K, Beckley-Kartey S, Melega S, Odueyungbo A, Kirchner P, Khalife N, Bangs J. Rituximab utilization for approved and off-label nononcology indications and patients' experiences with the Patient Alert Card. Pharmacol Res Perspect. 2020 Jan 3;8(1):e00555. doi: 10.1002/prp2.555. eCollection 2020 Feb. |
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| Percentage of Participants Who Read the PAC | Up to 10 months |
| Percentage of Participants Who Received Additional Safety-Related Materials | Up to 10 months |
| Corbeil-Essonnes |
| 91106 |
| France |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| Hopital Claude Huriez - CHU Lille | Lille | 59037 | France |
| Hôpital Lapeyronie | Montpellier | 34295 | France |
| CHU NANTES - Hôtel Dieu; Pharmacy | Nantes | 44093 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie | Pessac | 33600 | France |
| CHU Saint-Etienne, Hopital Bellevue | Saint-Etienne | 42055 | France |
| CHU de Toulouse - Hôpital Purpan | Toulouse | 31059 | France |
| Krankenhaus Dresden-Friedrichstadt | Dresden | 01067 | Germany |
| CIRI - Centrum für Innovative Diagnostik und Therapie GmbH | Frankfurt | 60528 | Germany |
| Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie | Freiburg im Breisgau | 79106 | Germany |
| Private Practice Dr. A. Liebhaber | Halle | 06128 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Schleswig-Holstein; Campus Lübeck | Lübeck | 23538 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | 55101 | Germany |
| Rheumazentrum Ratingen - Studienambulanz | Ratingen | 40878 | Germany |
| Fachkrankenhaus Vogelsang | Vogelsang-Gommern | 39245 | Germany |
| Azienda Ospedaliera Universitaria Arcispedale S. Anna | Ferrara | Emilia-Romagna | 44100 | Italy |
| IDI-Istituto Dermopatico dell'Immacolata IRCCS | Rome | Lazio | 00167 | Italy |
| Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto | Milan | Lombardy | 20122 | Italy |
| Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Ospedale San Giovanni Bosco | Turin | Piedmont | 10154 | Italy |
| Azienda Ospedaliera Giuseppe Brotzu | Cagliari | Sardinia | 09131 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50141 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| A.O.U. Senese Policlinico Santa Maria Alle Scotte | Siena | Tuscany | 53100 | Italy |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Regional Universitario de Malaga; Servicio de Reumatologia | Málaga | Malaga | 29009 | Spain |
| Hospital Meixoeiro | Vigo | Pontevedra | 36214 | Spain |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | 41071 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitari de Bellvitge; Servicio de Reumatologia | Barcelona | 08907 | Spain |
| Hospital Universitario San Cecilio | Granada | 18012 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario Valladolid | Valladolid | 47005 | Spain |
| Bristol Royal Infirmary | Bristol | BS2 8HW | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Southend University Hospital | Colchester | C03 3NB | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | EX2 5DW | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Salford Royal | Salford | M6 8HD | United Kingdom |
| Torbay Hospital | Torquay | TQ2 7AA | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LQ | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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