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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

NCT ID: NCT02654379

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1408 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-18

Study Completion Date

2017-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Off-Label Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort

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

Rituximab

Intervention Type BIOLOGICAL

Rituximab use in non-oncology indications

Interventions

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Rituximab

Rituximab use in non-oncology indications

Intervention Type BIOLOGICAL

Other Intervention Names

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MabThera

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Chu De Clermont Ferrand; Hopital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Centre Hospitalier Le Mans

Le Mans, , France

Site Status

Hopital Claude Huriez - CHU Lille

Lille, , France

Site Status

Hôpital Lapeyronie

Montpellier, , France

Site Status

CHU NANTES - Hôtel Dieu; Pharmacy

Nantes, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie

Pessac, , France

Site Status

CHU Saint-Etienne, Hopital Bellevue

Saint-Etienne, , France

Site Status

CHU de Toulouse - Hôpital Purpan

Toulouse, , France

Site Status

Krankenhaus Dresden-Friedrichstadt

Dresden, , Germany

Site Status

CIRI - Centrum für Innovative Diagnostik und Therapie GmbH

Frankfurt, , Germany

Site Status

Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie

Freiburg im Breisgau, , Germany

Site Status

Private Practice Dr. A. Liebhaber

Halle, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein; Campus Lübeck

Lübeck, , Germany

Site Status

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, , Germany

Site Status

Rheumazentrum Ratingen - Studienambulanz

Ratingen, , Germany

Site Status

Fachkrankenhaus Vogelsang

Vogelsang-Gommern, , Germany

Site Status

Azienda Ospedaliera Universitaria Arcispedale S. Anna

Ferrara, Emilia-Romagna, Italy

Site Status

IDI-Istituto Dermopatico dell'Immacolata IRCCS

Rome, Lazio, Italy

Site Status

Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto

Milan, Lombardy, Italy

Site Status

Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status

Ospedale San Giovanni Bosco

Turin, Piedmont, Italy

Site Status

Azienda Ospedaliera Giuseppe Brotzu

Cagliari, Sardinia, Italy

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Site Status

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Site Status

A.O.U. Senese Policlinico Santa Maria Alle Scotte

Siena, Tuscany, Italy

Site Status

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruña, Spain

Site Status

Hospital Regional Universitario de Malaga; Servicio de Reumatologia

Málaga, Malaga, Spain

Site Status

Hospital Meixoeiro

Vigo, Pontevedra, Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge; Servicio de Reumatologia

Barcelona, , Spain

Site Status

Hospital Universitario San Cecilio

Granada, , Spain

Site Status

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Clinico Universitario Valladolid

Valladolid, , Spain

Site Status

Bristol Royal Infirmary

Bristol, , United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Southend University Hospital

Colchester, , United Kingdom

Site Status

Royal Devon and Exeter Hospital (Wonford)

Exeter, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Salford Royal

Salford, , United Kingdom

Site Status

Torbay Hospital

Torquay, , United Kingdom

Site Status

Royal Cornwall Hospital

Truro, , United Kingdom

Site Status

New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Countries

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France Germany Italy Spain United Kingdom

References

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Sarsour 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.

Reference Type DERIVED
PMID: 31911839 (View on PubMed)

Other Identifiers

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BA28478

Identifier Type: -

Identifier Source: org_study_id

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