SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalim… (NCT05598684) | Clinical Trial Compass
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SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
France600 participantsStarted 2022-11-24
Plain-language summary
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Who can participate
Age range18 Years
SexALL
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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.)