One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study

Sponsor
Biogen
Study ID
NCT03662919
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    Administered as specified in the treatment arm.
  • Adalimumab — DRUG
    Administered as specified in the treatment arm.

Study Details

A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) \[adults and children\] and Ulcerative Colitis (UC) \[adults for both treatments and children only for Flixabi\].

Key Dates

Start date
Jul 2, 2018
Status verified
Oct 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
2,274 participants (actual)

Arms

  • Arm: Flixabi
    Infliximab naive participants or participants who were previously treated with other infliximab biologics will receive Flixabi (infliximab) as prescribed by physician according to the local prescribing procedures.
  • Arm: Imraldi
    Adalimumab naive participants or participants who were previously treated with other adalimumab biosimilars will receive Imraldi (adalimumab) as prescribed by physician according to the local prescribing procedures.

Primary Outcome Measure

Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months [ Time Frame: Up to 12 months ]

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