Overview
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Description
In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.
- Primary objective: to define predictive factors for the persistence of treatment
- Secondary objectives:
- To assess the therapeutic benefit and the tolerability of the treatment
- To describe the reasons for treatment discontinuations occurring during follow-up
Eligibility
Inclusion Criteria:
- Patient aged 18 years or over
- Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
- Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
- Patient for whom the investigator has decided, with patient's agreement and prior to
- inclusion
- Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
- Either to replace Humira® with a biosimilar (AdalimumabFK)
Exclusion Criteria:
- Patient enrolled in an interventional therapeutic trial at the time of inclusion
- Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)