Information and Acceptability of Biosimilars (BIOSIMINFO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis
• Intervention / Treatment: Other: Individual information by nurse on biosimilars; Other: Generic information leaflet

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cédric LUKAS; Phone Number: +33 467335651; Email: c-lukas@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • CHU, Service Immuno-rhumatologie, Département de rhumatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse information; The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars	Other: 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
Other: Information Leaflet; The patient will receive a generic information leaflet only	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Cédric LUKAS, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; Spondyloarthritis; Biologics; Biosimilars information
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis; Spondylarthritis
• Other Study ID Numbers: RECHMPL19_0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No