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

Sponsored by Biogen

About this trial

Last updated 3 years ago

Study ID

FRA-FLX-17-11226

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
6+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial 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].

What are the Participation Requirements?

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.

Locations

Location

Status

For more information, view the full study details:

NCT03662919