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NCT05598684
Assessment of Predictive Factors for Persistence of Treatment After Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
Conditions: Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Sex: All
Ages: 18 Years – N/A
Enrollment: 600
Sponsor: Fresenius Kabi, France
Summary
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Eligibility Criteria
Inclusion Criteria:Patient aged 18 years or overPatient who have been informed of the objectives and the conditions of the study and who did not object to its participationPatient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseasesPatient being treated with Humira® in whom the investigator has decided, with the patient's agreement and prior to enrolment, to replace Humira® with FK adalimumabExclusion Criteria:Patient enrolled in an interventional therapeutic trial at the time of inclusionPatient 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.)
Source: ClinicalTrials.gov (NCT05598684). StuddyBuddy aggregates publicly available trial information.