SAPHIR: 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
Study Details
Study Description
Brief Summary
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
In a population of adult patients previously treated with Humira® who are targeted to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.
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Primary objective: to define predictive factors for the persistence of treatment
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Secondary objectives:
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To assess the therapeutic benefit and the tolerability of the treatment
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To describe the reasons for treatment discontinuations occurring during follow-up
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort Patient being treated with Humira® in whom the investigator has decided, with the patient's agreement and prior to enrolment, to replace Humira® with FK adalimumab |
Outcome Measures
Primary Outcome Measures
- Persistence of the biosimilar [Month 12]
Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period
- Discontinuation of the biosimilar [Month 12]
Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
Secondary Outcome Measures
- Clinical status [Day 0]
Clinical Global Impression (CGI)-severity scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case)
- Maintenance of therapeutic benefit [Month 6]
Clinical Global Impression (CGI)-improvement scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case)
- Maintenance of therapeutic benefit [Month 12]
Clinical Global Impression (CGI)-improvement scale graded from 0 to 7 (0 is not evaluated, 1 is the best case and 7 the worst case)
- Treatment acceptance [Day 0]
Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire
- Quality of life assessment [Month 12]
Medical Outcome Study Short Form 12 (MOS SF-12) or "Short Form 12 " (SF-12) scale
- Emotional state [Month 12]
Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire.
- Tolerability evaluation [Month 12]
Collection of all adverse events (serious or non serious)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged 18 years or over
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Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
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Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
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Patient being treated with Humira® in whom the investigator has decided, with the patient's agreement and prior to enrolment, to replace Humira® with FK adalimumab
Exclusion Criteria:
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Patient enrolled in an interventional therapeutic trial at the time of inclusion
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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.)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fresenius Kabi, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-A00946-37