Off-Label Use Clinical Trial
Official title:
MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach
| Verified date | April 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1408 |
| Est. completion date | September 29, 2017 |
| Est. primary completion date | September 29, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Participant is in the center to receive an infusion for rituximab for a non-oncology indication during the study period - Aged 18 years or older Exclusion Criteria: - Has previously already completed the rituximab survey - Has participated in the past 12 months in a clinical trial in which rituximab was one of the treatments being evaluated. |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu De Clermont Ferrand; Hopital Gabriel Montpied | Clermont Ferrand | |
| France | Centre Hospitalier Sud Francilien | Corbeil Essonnes | |
| France | Centre Hospitalier Le Mans | Le Mans | |
| France | Hopital Claude Huriez - CHU Lille | Lille | |
| France | Hôpital Lapeyronie | Montpellier | |
| France | CHU NANTES - Hôtel Dieu; Pharmacy | Nantes | |
| France | Hôpital Cochin | Paris | |
| France | Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie | Pessac | |
| France | CHU Saint-Etienne, Hopital Bellevue | Saint-Etienne | |
| France | CHU de Toulouse - Hôpital Purpan | Toulouse | |
| Germany | Krankenhaus Dresden-Friedrichstadt | Dresden | |
| Germany | CIRI - Centrum für Innovative Diagnostik und Therapie GmbH | Frankfurt | |
| Germany | Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie | Freiburg | |
| Germany | Private Practice Dr. A. Liebhaber | Halle | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Universitätsklinikum Schleswig-Holstein; Campus Lübeck | Lübeck | |
| Germany | Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | |
| Germany | Rheumazentrum Ratingen - Studienambulanz | Ratingen | |
| Germany | Fachkrankenhaus Vogelsang | Vogelsang-Gommern | |
| Italy | Azienda Ospedaliera Giuseppe Brotzu | Cagliari | Sardegna |
| Italy | Azienda Ospedaliera Universitaria Arcispedale S. Anna | Ferrara | Emilia-Romagna |
| Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | Toscana |
| Italy | Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto | Milano | Lombardia |
| Italy | Ospedale San Raffaele | Milano | Lombardia |
| Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | Toscana |
| Italy | IDI-Istituto Dermopatico dell'Immacolata IRCCS | Roma | Lazio |
| Italy | A.O.U. Senese Policlinico Santa Maria Alle Scotte | Siena | Toscana |
| Italy | Ospedale San Giovanni Bosco | Torino | Piemonte |
| Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | LA Coruña |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Universitari de Bellvitge; Servicio de Reumatologia | Barcelona | |
| Spain | Hospital Universitario San Cecilio | Granada | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Clínico San Carlos | Madrid | |
| Spain | Hospital Regional Universitario de Malaga; Servicio de Reumatologia | Málaga | Malaga |
| Spain | Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona |
| Spain | Hospital Universitario Virgen Macarena | Seville | Sevilla |
| Spain | Hospital Clinico Universitario Valladolid | Valladolid | |
| Spain | Hospital Meixoeiro | Vigo | Pontevedra |
| United Kingdom | Bristol Royal Infirmary | Bristol | |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | Southend University Hospital | Colchester | |
| United Kingdom | Royal Devon and Exeter Hospital (Wonford) | Exeter | |
| United Kingdom | Derriford Hospital | Plymouth | |
| United Kingdom | Salford Royal | Salford | |
| United Kingdom | Torbay Hospital | Torquay | |
| United Kingdom | Royal Cornwall Hospital | Truro | |
| United Kingdom | New Cross Hospital | Wolverhampton |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
France, Germany, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab | Up to 10 months | ||
| Primary | Percentage of Participants Using Rituximab Off-Label | Up to 10 months | ||
| Secondary | Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA) | Up to 10 months | ||
| Secondary | Percentage of Participants Who Received the Patient Alert Card (PAC) | Up to 10 months | ||
| Secondary | Percentage of Participants Who Read the PAC | Up to 10 months | ||
| Secondary | Percentage of Participants Who Received Additional Safety-Related Materials | Up to 10 months |