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 Overview
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Brief Summary
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A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.

Detailed Description
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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. 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

Official Title
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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
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Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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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 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: 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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of the biosimilar | Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period | Month 12 | 
| Discontinuation of the biosimilar | Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status | 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) | Day 0 | 
| Maintenance of therapeutic benefit | 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) | Month 6 | 
| Maintenance of therapeutic benefit | 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) | Month 12 | 
| Treatment acceptance | Acceptance of the chronic treatment assessed on D0 using the Accept® questionnaire | Day 0 | 
| Quality of life assessment | Medical Outcome Study Short Form 12 (MOS SF-12) or Short Form 12  (SF-12) scale | Month 12 | 
| Emotional state | Screening for symptoms of anxiety and depression involves the use of the HAD questionnaire. | Month 12 | 
| Tolerability evaluation | Collection of all adverse events (serious or non serious) | Month 12 |