Completed

NCT Number: NCT02654379

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

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.

Completed

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Key information

Conditions

Off-Label Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu De Clermont Ferrand; Hopital Gabriel Montpied, Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Biological

Rituximab use in non-oncology indications

Other names: MabThera

Primary outcomes

Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab

Time frame: Up to 10 months
Percentage of Participants Using Rituximab Off-Label

Time frame: Up to 10 months

Secondary outcomes

Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)

Time frame: Up to 10 months
Percentage of Participants Who Received the Patient Alert Card (PAC)

Time frame: Up to 10 months
Percentage of Participants Who Read the PAC

Time frame: Up to 10 months
Percentage of Participants Who Received Additional Safety-Related Materials

Time frame: Up to 10 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jan 13, 2016
Registry last updated: Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.