Information and Acceptability of Biosimilars

  • STATUS
    Recruiting
  • End date
    Nov 26, 2023
  • participants needed
    500
  • sponsor
    University Hospital, Montpellier
Updated on 26 November 2021
adalimumab
tumor necrosis factor
etanercept
arthritis
biosimilar
spondyloarthropathy
rheumatic diseases
rheumatism
rheumatoid arthritis

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.

Details
Condition Spondyloarthropathy, Psoriasis and Psoriatic Disorders, Arthritis and Arthritic Pain (Pediatric), Arthritis and Arthritic Pain, Spondylarthritis, Psoriasis, spondyloarthritis, Psoriatic Arthritis, PSORIATIC ARTHRITIS, Arthritis, Rheumatoid Arthritis (Pediatric), Rheumatoid Arthritis
Treatment Generic information leaflet, Individual information by nurse on biosimilars
Clinical Study IdentifierNCT04321291
SponsorUniversity Hospital, Montpellier
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

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
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