Clinical trial 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
Official title: MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Off-Label Use
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 1408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab
timeFrame: Up to 10 months
measure: Percentage of Participants Using Rituximab Off-Label
timeFrame: Up to 10 months
Secondary outcomes:
measure: Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)
timeFrame: Up to 10 months
measure: Percentage of Participants Who Received the Patient Alert Card (PAC)
timeFrame: Up to 10 months
measure: Percentage of Participants Who Read the PAC
timeFrame: Up to 10 months
measure: Percentage of Participants Who Received Additional Safety-Related Materials
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Chu De Clermont Ferrand; Hopital Gabriel Montpied
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Lille
country: France
facility: Hopital Claude Huriez - CHU Lille
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Nantes
country: France
facility: CHU NANTES - Hôtel Dieu; Pharmacy
city: Paris
country: France
facility: Hôpital Cochin
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne, Hopital Bellevue
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
city: Frankfurt
country: Germany
facility: CIRI - Centrum für Innovative Diagnostik und Therapie GmbH
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie
city: Halle
country: Germany
facility: Private Practice Dr. A. Liebhaber
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen - Studienambulanz
city: Vogelsang-Gommern
country: Germany
facility: Fachkrankenhaus Vogelsang
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale S. Anna
state: Emilia-Romagna
city: Roma
country: Italy
facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS
state: Lazio
city: Milano
country: Italy
facility: Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
state: Piemonte
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Giuseppe Brotzu
state: Sardegna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte
state: Toscana
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: LA Coruña
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga; Servicio de Reumatologia
state: Malaga
city: Vigo
country: Spain
facility: Hospital Meixoeiro
state: Pontevedra
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Sevilla
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario Valladolid
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Colchester
country: United Kingdom
facility: Southend University Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Salford
country: United Kingdom
facility: Salford Royal
city: Torquay
country: United Kingdom
facility: Torbay Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.