Clinical trial · Observational
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
MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Off-Label Use | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- description
- Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication.
- interventionNames
- Biological: Rituximab
Primary outcomes (2)
- measure
- Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab
- timeFrame
- Up to 10 months
- measure
- Percentage of Participants Using Rituximab Off-Label
- timeFrame
- Up to 10 months
Secondary outcomes (4)
- measure
- Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSarsour 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. PMID 31911839