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

Fresenius Kabi

Status: Enrolling

Conditions: Psoriatic Arthritis; Ulcerative Colitis; Ankylosing Spondylitis; Crohn Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05598684

2022-A00946-37

Details and patient eligibility

About

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

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

600 participants in 1 patient group

Cohort

Description:

Adult patients who agreed to initiate treatment with a biosimilar (adalimumab FK) or to replace the reference adalimumab with the adalimumab FK biosimilar