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

April 6, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63003
        • Chu De Clermont Ferrand; Hopital Gabriel Montpied
      • Corbeil Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans
      • Lille, France, 59037
        • Hopital Claude Huriez - CHU Lille
      • Montpellier, France, 34295
        • Hôpital Lapeyronie
      • Nantes, France, 44093
        • CHU NANTES - Hôtel Dieu; Pharmacy
      • Paris, France, 75014
        • Hôpital Cochin
      • Pessac, France, 33600
        • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne, Hopital Bellevue
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Purpan
  • Germany
      • Dresden, Germany, 01067
        • Krankenhaus Dresden-Friedrichstadt
      • Frankfurt, Germany, 60528
        • CIRI - Centrum für Innovative Diagnostik und Therapie GmbH
      • Freiburg, Germany, 79106
        • Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie
      • Halle, Germany, 06128
        • Private Practice Dr. A. Liebhaber
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein; Campus Lübeck
      • Mainz, Germany, 55101
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
      • Ratingen, Germany, 40878
        • Rheumazentrum Ratingen - Studienambulanz
      • Vogelsang-Gommern, Germany, 39245
        • Fachkrankenhaus Vogelsang
  • Italy
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44100
        • Azienda Ospedaliera Universitaria Arcispedale S. Anna
    • Lazio
      • Roma, Lazio, Italy, 00167
        • IDI-Istituto Dermopatico dell'Immacolata IRCCS
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Lombardia, Italy, 20122
        • Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto
    • Piemonte
      • Torino, Piemonte, Italy, 10154
        • Ospedale San Giovanni Bosco
    • Sardegna
      • Cagliari, Sardegna, Italy, 09131
        • Azienda Ospedaliera Giuseppe Brotzu
    • Toscana
      • Firenze, Toscana, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Pisa, Toscana, Italy, 56100
        • Azienda Ospedaliero Universitaria Pisana
      • Siena, Toscana, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Spain
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge; Servicio de Reumatologia
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario Valladolid
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
    • Malaga
      • Málaga, Malaga, Spain, 29009
        • Hospital Regional Universitario de Malaga; Servicio de Reumatologia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36214
        • Hospital Meixoeiro
    • Sevilla
      • Seville, Sevilla, Spain, 41071
        • Hospital Universitario Virgen Macarena
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Colchester, United Kingdom, C03 3NB
        • Southend University Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
      • Plymouth, United Kingdom, Pl6 8DH
        • Derriford Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants in the center to receive an infusion for rituximab for a non-oncology indication during the study period.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication.
Biological: Rituximab
Rituximab use in non-oncology indications
Other Names:
  • MabThera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab
Time Frame: Up to 10 months
Up to 10 months
Percentage of Participants Using Rituximab Off-Label
Time Frame: Up to 10 months
Up to 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)
Time Frame: Up to 10 months
Up to 10 months
Percentage of Participants Who Received the Patient Alert Card (PAC)
Time Frame: Up to 10 months
Up to 10 months
Percentage of Participants Who Read the PAC
Time Frame: Up to 10 months
Up to 10 months
Percentage of Participants Who Received Additional Safety-Related Materials
Time Frame: Up to 10 months
Up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2015

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA28478

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Off-Label Use

Clinical Trials on Rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe