Off-Label UseNCT02654379
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
An observational study of Off-Label Use, run by Hoffmann-La Roche at 48 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Off-Label Use
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 1,408 participants
- Where
- 48 sitesin 5 countries
- Study dates
- 18 Dec 2015to 29 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the center to receive an infusion for rituximab for a non-oncology indication during the study period.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
48 sites in 5 countries.
48 sites in 5 countries
Spain11 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruña, 15006
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitari de Bellvitge; Servicio de Reumatologia
Barcelona, 08907
Hospital Universitario San Cecilio
Granada, 18012
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario de Malaga; Servicio de Reumatologia
Málaga, Malaga, 29009
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071
Hospital Clinico Universitario Valladolid
Valladolid, 47005
Hospital Meixoeiro
Vigo, Pontevedra, 36214
France10 sites
Chu De Clermont Ferrand; Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
Centre Hospitalier Le Mans
Le Mans, 72037
Hopital Claude Huriez - CHU Lille
Lille, 59037
Hôpital Lapeyronie
Montpellier, 34295
CHU NANTES - Hôtel Dieu; Pharmacy
Nantes, 44093
Hôpital Cochin
Paris, 75014
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie
Pessac, 33600
CHU Saint-Etienne, Hopital Bellevue
Saint-Etienne, 42055
CHU de Toulouse - Hôpital Purpan
Toulouse, 31059
Germany9 sites
Krankenhaus Dresden-Friedrichstadt
Dresden, 01067
CIRI - Centrum für Innovative Diagnostik und Therapie GmbH
Frankfurt, 60528
Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie
Freiburg im Breisgau, 79106
Private Practice Dr. A. Liebhaber
Halle, 06128
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
Lübeck, 23538
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55101
Rheumazentrum Ratingen - Studienambulanz
Ratingen, 40878
Fachkrankenhaus Vogelsang
Vogelsang-Gommern, 39245
Italy9 sites
Azienda Ospedaliera Giuseppe Brotzu
Cagliari, Sardinia, 09131
Azienda Ospedaliera Universitaria Arcispedale S. Anna
Ferrara, Emilia-Romagna, 44100
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141
Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto
Milan, Lombardy, 20122
Ospedale San Raffaele
Milan, Lombardy, 20132
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100
IDI-Istituto Dermopatico dell'Immacolata IRCCS
Rome, Lazio, 00167
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena, Tuscany, 53100
Ospedale San Giovanni Bosco
Turin, Piedmont, 10154
United Kingdom9 sites
Bristol Royal Infirmary
Bristol, BS2 8HW
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Southend University Hospital
Colchester, C03 3NB
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW
Derriford Hospital
Plymouth, PL6 8DH
Salford Royal
Salford, M6 8HD
Torbay Hospital
Torquay, TQ2 7AA
Royal Cornwall Hospital
Truro, TR1 3LQ
New Cross Hospital
Wolverhampton, WV10 0QP
About this study
Official title: 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.
- Conditions
- Off-Label Use
- Being tested
- Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabBiological
Also called MabThera
Rituximab use in non-oncology indications
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication. Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab
Measured: Up to 10 months
Percentage of Participants Using Rituximab Off-Label
Measured: Up to 10 months
Secondary outcomes (4)
Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)
Measured: Up to 10 months
Percentage of Participants Who Received the Patient Alert Card (PAC)
Measured: Up to 10 months
Percentage of Participants Who Read the PAC
Measured: Up to 10 months
Percentage of Participants Who Received Additional Safety-Related Materials
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start18 Dec 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Off-Label UseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654379
- Sponsor's protocol ID
- BA28478
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2016
- Last updated
- 9 Apr 2018
- Results posted
- No
Publications
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.
PubMed 31911839
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach
- ClinicalTrials.gov ID
- NCT02654379
- Acronym / sponsor ID
- BA28478
- Conditions
- Off-Label Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,408 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Biological: RituximabCohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the center to receive an infusion for rituximab for a non-oncology indication during the study period.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: MabTheraRituximab use in non-oncology indications | Biological | Cohort |
Primary outcome
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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Derived from this study: PubMed 31911839Sarsour 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.
Related trials for Off-Label Use
RecruitingObservational study
Pharmacokinetics of Off Label Pediatric Medications
Off Label Use of Medications in Pediatric Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
48 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Off-Label Use, run by Hoffmann-La Roche at 48 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Spain, France, Germany, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab (time frame: Up to 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.