NCT05598684

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Fresenius Kabi, France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Crohn Disease
• Ulcerative Colitis
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis

Timeline

• Start date: 2022-11-24
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2022-10-28
• Last updated: 2024-06-12

Locations

96 sites across 3 countries: France, Guadeloupe, Martinique