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
- 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
- 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 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 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
Trial Locations
- Locations (48)
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, France
Scroll for more (38 remaining)Chu De Clermont Ferrand; Hopital Gabriel Montpied🇫🇷Clermont Ferrand, France