Information and Acceptability of Biosimilars (BIOSIMINFO)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Spondyloarthritis; Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Other: Individual information by nurse on biosimilars; Other: Generic information leaflet

Study type: Interventional

Funder types: Other

Identifiers

NCT04321291

RECHMPL19_0084

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 2 patient groups

Nurse information

Experimental group

Description:

The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars

Treatment:

Other: Individual information by nurse on biosimilars

Information Leaflet

Other group

Description:

The patient will receive a generic information leaflet only

Treatment:

Other: Generic information leaflet