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

Biogen

Status: Completed

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

Treatments: Drug: Infliximab; Drug: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03662919

2017-A03220-53 (Registry Identifier)

FRA-FLX-17-11226

Details and patient eligibility

About

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].

Enrollment: 2,274 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/ Exclusion Criteria

Key Inclusion Criteria:

• Adult participant (18 years and over)

  • treated for one of the following conditions: RA, AS, PsA, CD, UC.
  • either active substance naïve or treated with the originator or another biosimilar at baseline.
  • for whom the treating physician has decided to treat by (naïve) or switch from originator or another biosimilar to Flixabi or Imraldi.
  • participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.

• Paediatric participants (6-17 years):

  • treated for one of the following conditions: CD, UC.
  • either active substance naïve or treated with another biosimilar at baseline.
  • for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (for both indications) or Imraldi (only for Crohn's disease).
  • participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.

Key Exclusion Criteria:

• Participant treated for psoriasis.
• Participant who are not to be followed up in the same investigator site for 2 years after baseline.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

2,274 participants in 2 patient groups

Flixabi

Description:

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.

Treatment:

Drug: Infliximab

Imraldi

Description:

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.

Treatment:

Drug: Adalimumab