SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI... | NCT05598684 | Trialant
Unknown statusObservationalUpdated Jun 12, 2024
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
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
ClinicalTrials.gov ID
NCT05598684
Lead Sponsor
Fresenius Kabi, FranceINDUSTRY
Overall Status
Unknown status
Study Type
Observational
Enrollment
600Estimated
Last Update Posted
Jun 12, 2024Actual
Start Date
Nov 24, 2022Actual
Primary Completion Date
Sep 30, 2025Estimated
Completion Date
Dec 30, 2025Estimated
Official Title
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
Brief Summary
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
Detailed 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
Crohn Disease
Ulcerative Colitis
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)