Observational Study Evaluating Rituximab Use and Use of the Patient Alert Card in Participants Receiving Rituximab Infusion for a Non-Oncology Indication at Infusion Centers in Europe
- Conditions
- Off-Label Use
- Interventions
- Biological: Rituximab
- Registration Number
- NCT02654379
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1408
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Rituximab Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA) Up to 10 months Percentage of Participants Who Read the PAC Up to 10 months Percentage of Participants Who Received the Patient Alert Card (PAC) Up to 10 months Percentage of Participants Who Received Additional Safety-Related Materials Up to 10 months
Trial Locations
- Locations (48)
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, LA Coruña, Spain
Hopital Claude Huriez - CHU Lille
🇫🇷Lille, France
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
IDI-Istituto Dermopatico dell'Immacolata IRCCS
🇮🇹Roma, Lazio, Italy
Royal Devon and Exeter Hospital (Wonford)
🇬🇧Exeter, United Kingdom
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Clínico San Carlos
🇪🇸Madrid, Spain
CHU NANTES - Hôtel Dieu; Pharmacy
🇫🇷Nantes, France
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Torbay Hospital
🇬🇧Torquay, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Hospital Universitari de Bellvitge; Servicio de Reumatologia
🇪🇸Barcelona, Spain
Southend University Hospital
🇬🇧Colchester, United Kingdom
Hospital Meixoeiro
🇪🇸Vigo, Pontevedra, Spain
Rheumazentrum Ratingen - Studienambulanz
🇩🇪Ratingen, Germany
Salford Royal
🇬🇧Salford, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario Valladolid
🇪🇸Valladolid, Spain
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Regional Universitario de Malaga; Servicio de Reumatologia
🇪🇸Málaga, Malaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Seville, Sevilla, Spain
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Chu De Clermont Ferrand; Hopital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Hôpital Lapeyronie
🇫🇷Montpellier, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie
🇫🇷Pessac, France
Krankenhaus Dresden-Friedrichstadt
🇩🇪Dresden, Germany
Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto
🇮🇹Milano, Lombardia, Italy
Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Ospedale San Giovanni Bosco
🇮🇹Torino, Piemonte, Italy
Hôpital Cochin
🇫🇷Paris, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil Essonnes, France
CHU Saint-Etienne, Hopital Bellevue
🇫🇷Saint-Etienne, France
Private Practice Dr. A. Liebhaber
🇩🇪Halle, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
A.O.U. Senese Policlinico Santa Maria Alle Scotte
🇮🇹Siena, Toscana, Italy
Azienda Ospedaliera Giuseppe Brotzu
🇮🇹Cagliari, Sardegna, Italy
CHU de Toulouse - Hôpital Purpan
🇫🇷Toulouse, France
Azienda Ospedaliera Universitaria Arcispedale S. Anna
🇮🇹Ferrara, Emilia-Romagna, Italy
CIRI - Centrum für Innovative Diagnostik und Therapie GmbH
🇩🇪Frankfurt, Germany
Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie
🇩🇪Freiburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
🇩🇪Lübeck, Germany
Fachkrankenhaus Vogelsang
🇩🇪Vogelsang-Gommern, Germany
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain