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

Launched by FRESENIUS KABI, FRANCE · Oct 27, 2022

Keywords

ClinConnect Summary

The SAPHIR trial is a study looking at how well patients with chronic inflammatory diseases, like Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, continue their treatment after starting a specific medication called adalimumab or its biosimilar version, Adalimumab FK. The goal is to understand what factors help patients stick with their treatment over time. This study is taking place in multiple locations across France and is currently recruiting participants.

To be eligible for this trial, you need to be at least 18 years old and have a diagnosis of one of the mentioned chronic inflammatory diseases. You should also be willing to either start the biosimilar medication or switch from the original adalimumab (known as Humira) to the biosimilar. Participants can expect to be followed over time to see how they respond to the treatment and whether they continue using it as prescribed. It's important to note that if you're already involved in another clinical trial or are unable to complete the study requirements, you won't be able to participate in this study.

Gender

ALL

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.)