Information and Acceptability of Biosimilars

Rheumatoid Arthritis Clinical Trial

— BIOSIMINFO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321291
• Other study ID #: RECHMPL19_0084
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Montpellier
• Contact: Cédric LUKAS
• Phone: 467335651
• Email: c-lukas[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU, Service Immuno-rhumatologie, Département de rhumatologie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed rate of prescribed biosimilars	The measure is the number of patient who accept the biosimilars	18 months
Secondary	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
Secondary	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
Secondary	Reasons for refusal of biosimilars	The measure is done by the completion of a questionnaire by the patient	18 months