The primary objective of the study is to compare, in patients treated with methotrexate injection for rheumatoid arthritis, the compliance and the health assessment questionnaire evolution for the administration by auto-injector versus administration by conventional subcutaneous injection, after 6 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
278
SARAUX
Brest, France
HUDRY
Paris, France
Co-primary criteria: observance and health assessment questionnaire
the health assessment questionnaire is completed by the patient at inclusion visit and at the 6 months visit. Compliance with methotrexate treatment will be assessed by the investigator at each visit
Time frame: 6 months
quality of life
Patient's quality of life will be assessed using a validated questionnaire. completed by the patient at inclusion and 6 months visits. Change from baseline in questionnaire score will be described.
Time frame: 6 months
acceptability
The product acceptability will be evaluated by the patient using a specific questionnaire based on several questions related to the patient' opinion, satisfaction and willingness to adopt the product.
Time frame: up to 1 year
preference
Preference will be assessed only for patients receiving auto-injector and pre-filled syringe of methotrexate
Time frame: 6 months
Economic
Information on the consumed resources for methotrexate administration will be assessed at 6 months. This information will be further incorporated in a budget impact for the French Sickness Fund
Time frame: 6 months
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