Information and Acceptability of Biosimilars

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Nurse's Specific Information on the Acceptability of Biosimilars in Chronic Inflammatory Rheumatism

Conditions
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Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis

Intervention / Treatment
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* Other: Generic information leaflet
* Other: Individual information by nurse on biosimilars


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse information<br>The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars | Other: Individual information by nurse on biosimilars<br>* 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<br>|
| Other: Information Leaflet<br>The patient will receive a generic information leaflet only | Other: Generic information leaflet<br>* The information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed rate of prescribed biosimilars | The measure is the number of patient who accept the biosimilars | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average time spent by nurse to inform patients | the measure is done by the completion of a questionnaire by the nurse who report the time spent with the patient | 18 months | 
| Proportion of patients from the intervention arm having actually received specific information by nurse | Verify the number of patient who receive the information thanks to the nurse questionnaire | 18 months | 
| Reasons for refusal of biosimilars | The measure is done by the completion of a questionnaire by the patient | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Spondyloarthritis, Biologics, Biosimilars information