Information and Acceptability of Biosimilars
BIOSIMINFO
Impact of a Nurse's Specific Information on the Acceptability of Biosimilars in Chronic Inflammatory Rheumatism
1 other identifier
interventional
500
1 country
1
Brief Summary
Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist for periodic assessment of disease and treatment. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Jul 2020
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedApril 6, 2023
April 1, 2023
3.3 years
March 23, 2020
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observed rate of prescribed biosimilars
The measure is the number of patient who accept the biosimilars
18 months
Secondary Outcomes (3)
Average time spent by nurse to inform patients
18 months
Proportion of patients from the intervention arm having actually received specific information by nurse
18 months
Reasons for refusal of biosimilars
18 months
Study Arms (2)
Nurse information
EXPERIMENTALThe patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars
Information Leaflet
OTHERThe patient will receive a generic information leaflet only
Interventions
The information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator.
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
You may qualify if:
- Age 18 and over (no upper age limit)
- 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
You may not qualify if:
- Unable to understand information (not fluent in the French language, severe cognitive impairment, etc.)
- Known intolerance to one of the proposed biosimilar excipients
- Vulnerable persons: pregnant woman, minor patient, deprived of liberty, under guardianship or under curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU, Service Immuno-rhumatologie, Département de rhumatologie
Montpellier, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cédric LUKAS
Montpellier University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
July 2, 2020
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
April 6, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share