Status:
UNKNOWN
Information and Acceptability of Biosimilars
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Rheumatoid Arthritis
Spondyloarthritis
Eligibility:
All Genders
18-100 years
Phase:
NA
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 " infor...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04321291
Start Date
July 2 2020
End Date
November 1 2023
Last Update
April 6 2023
Active Locations (1)
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1
CHU, Service Immuno-rhumatologie, Département de rhumatologie
Montpellier, France