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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hopital 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
        • Universitatsklinikum 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 Clinico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings