Information and Acceptability of Biosimilars

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis
• Interventions: Other: Individual information by nurse on biosimilars; Other: Generic information leaflet

• Registration Number: NCT04321291
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-07-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse information	Individual information by nurse on biosimilars	The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars
Information Leaflet	Generic information leaflet	The patient will receive a generic information leaflet only

Primary Outcome Measures

Name	Time	Method
Observed rate of prescribed biosimilars	18 months	The measure is the number of patient who accept the biosimilars

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU, Service Immuno-rhumatologie, Département de rhumatologie; 🇫🇷 Montpellier, France