Clinical trial NCT04321291: Information and Acceptability of Biosimilars
Official title: Impact of a Nurse's Specific Information on the Acceptability of Biosimilars in Chronic Inflammatory Rheumatism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Psoriatic Arthritis
Keywords: Rheumatoid arthritis
Spondyloarthritis
Biologics
Biosimilars information
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Observed rate of prescribed biosimilars
timeFrame: 18 months
Secondary outcomes:
measure: Average time spent by nurse to inform patients
timeFrame: 18 months
measure: Proportion of patients from the intervention arm having actually received specific information by nurse
timeFrame: 18 months
measure: Reasons for refusal of biosimilars
timeFrame: 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU, Service Immuno-rhumatologie, Département de rhumatologie
Study officials:
affiliation: Montpellier University Hospital
name: Cédric LUKAS
role: PRINCIPAL_INVESTIGATOR
References: