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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — BIOLOGICAL
  Rituximab use in non-oncology indications

Study Details

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.

Key Dates

Start date

Dec 18, 2015

Status verified

Apr 2018

Primary completion

Sep 29, 2017

Completion

Sep 29, 2017

Study Design

Enrollment

1,408 participants (actual)

Arms

• Arm: Cohort
  Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication.

Primary Outcome Measure

Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab [ Time Frame: Up to 10 months ]