Study Results
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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UNKNOWN
NA
500 participants
INTERVENTIONAL
2020-07-02
2023-11-30
Brief Summary
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Patients from the " information leaflet only " arm will be distributed individually a dedicated leaflet with written generic informations about the use of biosimilars in rheumatic diseases (individual and societal advantages, pharmaceutical development, scientific efficacy and safety results).
Patients from the " " information leaflet + nurse information " arm will be delivered the same leaflet, and additionally offered to have a dedicated individual interview with a specialist nurse, who will orally discuss informations about biosimilars based on a standardized talk, completed by answers to any questions by the patient.
The rheumatologist will then propose, unless inappropriate based on clinical evaluation of the patient, a change in the treatment of patients from the original drug to the corresponding biosimilar.
The primary outcome will be the observed proportions of patients actually receiving the biosimilar drug at the 6-months follow-up visit in the 2 compared arms.
Secondary outcomes will be average time spent by the nurse to adequatley inform the patient, the proportion of patients from the intervention arm who have actually asked for the nurse information interview, and the reasons for refusal of biosimilars, when appropriate.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Nurse information
The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars
Individual information by nurse on biosimilars
Delivery of the same information leaflet, completed if asked by the patient, by individual meeting with specialist nurse, including generic and standardized informations on specificities, advantages and current scientific knowledge about biosimilars in inflammatory rheumatic diseases. This is in addition to the information given by the investigator
Information Leaflet
The patient will receive a generic information leaflet only
Generic information leaflet
The information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator.
Interventions
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Generic information leaflet
The information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator.
Individual information by nurse on biosimilars
Delivery of the same information leaflet, completed if asked by the patient, by individual meeting with specialist nurse, including generic and standardized informations on specificities, advantages and current scientific knowledge about biosimilars in inflammatory rheumatic diseases. This is in addition to the information given by the investigator
Eligibility Criteria
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Inclusion Criteria
* All adult patients seen in rheumatology consultation at the Montpellier Hospital
* With inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis).
* Treated (or in the process of being treated at the end of the consultation) by etanercept or adalimumab
* In whom the biomedical treatment already used should in principle be renewed without modification (patient deemed good responder and well tolerant of the treatment)
* Or where biomedical initiation has just been indicated during the consultation
* Member of a social security scheme
* Informed and written consent
Exclusion Criteria
* Known intolerance to one of the proposed biosimilar excipients
* Vulnerable persons: pregnant woman, minor patient, deprived of liberty, under guardianship or under curatorship
18 Years
100 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Cédric LUKAS
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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CHU, Service Immuno-rhumatologie, Département de rhumatologie
Montpellier, , France
Countries
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Central Contacts
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Other Identifiers
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RECHMPL19_0084
Identifier Type: -
Identifier Source: org_study_id
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