Off-Label Use
Conditions
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.
Interventions
BIOLOGICALRituximab
Rituximab use in non-oncology indications
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Percentage of Participants Who Read the PAC | Up to 10 months |
| Percentage of Participants Who Received Additional Safety-Related Materials | Up to 10 months |
Countries
France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed