Clinical trial NCT03662919: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study
Official title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylitis, Ankylosing
Arthritis, Psoriatic
Crohn's Disease
Colitis, Ulcerative
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 2274
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants either infliximab naïve or switched from Remicade or CT-P13 to Flixabi who are treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi who are treated with Imraldi, for RA, AS, PsA, CD, and UC as prescribed by the physician in clinical practice.

Brief summary: 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) \[adults for both treatments and children only for Flixabi\].


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caluire et Cuire
country: France
facility: Research Site
state: Auvergne-Rhône-Alpes
city: Clermont-Ferrand
country: France
facility: Research Site 1
state: Auvergne-Rhône-Alpes
city: Clermont-Ferrand
country: France
facility: Research Site
state: Auvergne-Rhône-Alpes
city: Lyon
country: France
facility: Research Site
state: Auvergne-Rhône-Alpes
city: Pierre-Bénite
country: France
facility: Research Site 1
state: Auvergne-Rhône-Alpes
city: Pierre-Bénite
country: France
facility: Research Site
state: Auvergne-Rhône-Alpes
city: Saint-Etienne
country: France
facility: Research Site
state: Auvergne-Rhône-Alpes
city: Dijon
country: France
facility: Research Site
state: Bourgogne-Franche-Comté
city: Brest
country: France
facility: Research Site 1
state: Bretagne
city: Brest
country: France
facility: Research Site
state: Bretagne
city: Rennes
country: France
facility: Research Site
state: Bretagne
city: Chambray les Tours
country: France
facility: Research Site
state: Centre-Val De Loire
city: Orléans
country: France
facility: Research Site
state: Centre-Val De Loire
city: Reims
country: France
facility: Research Site
state: Grand Est
city: Strasbourg
country: France
facility: Research Site
state: Grand Est
city: Vandoeuvre-lès-Nancy
country: France
facility: Research Site 1
state: Grand Est
city: Vandoeuvre-lès-Nancy
country: France
facility: Research Site
state: Grand Est
city: Amiens
country: France
facility: Research Site
state: Hauts-de-France
city: Lille
country: France
facility: Research Site 1
state: Hauts-de-France
city: Lille
country: France
facility: Research Site
state: Hauts-de-France
city: Bobigny
country: France
facility: Research Site 1
state: Ile De France
city: Bobigny
country: France
facility: Research Site
state: Ile De France
city: Clichy
country: France
facility: Research Site
state: Ile De France
city: Colombes
country: France
facility: Research Site
state: Ile De France
city: Créteil
country: France
facility: Research Site
state: Ile De France
city: Le Kremlin-Bicêtre
country: France
facility: Research Site
state: Ile De France
city: Paris
country: France
facility: Research Site 10
state: Ile De France
city: Paris
country: France
facility: Research Site 1
state: Ile De France
city: Paris
country: France
facility: Research Site 2
state: Ile De France
city: Paris
country: France
facility: Research Site 3
state: Ile De France
city: Paris
country: France
facility: Research Site 4
state: Ile De France
city: Paris
country: France
facility: Research Site 5
state: Ile De France
city: Paris
country: France
facility: Research Site 6
state: Ile De France
city: Paris
country: France
facility: Research Site 7
state: Ile De France
city: Paris
country: France
facility: Research Site 8
state: Ile De France
city: Paris
country: France
facility: Research Site 9
state: Ile De France
city: Paris
country: France
facility: Research Site
state: Ile De France
city: Caen
country: France
facility: Research Site
state: Normandie
city: Rouen
country: France
facility: Research Site
state: Normandie
city: Bayonne
country: France
facility: Research Site
state: Nouvelle-Aquitaine
city: Bordeaux
country: France
facility: Research Site
state: Nouvelle-Aquitaine
city: La Rochelle
country: France
facility: Research Site 1
state: Nouvelle-Aquitaine
city: La Rochelle
country: France
facility: Research Site 2
state: Nouvelle-Aquitaine
city: La Rochelle
country: France
facility: Research Site
state: Nouvelle-Aquitaine
city: Limoges
country: France
facility: Research Site
state: Nouvelle-Aquitaine
city: Montpellier
country: France
facility: Research Site 1
state: Occitanie
city: Montpellier
country: France
facility: Research Site
state: Occitanie
city: Nîmes
country: France
facility: Research Site 1
state: Occitanie
city: Nîmes
country: France
facility: Research Site
state: Occitanie
city: Toulouse
country: France
facility: Research Site 1
state: Occitanie
city: Toulouse
country: France
facility: Research Site
state: Occitanie
city: Angers
country: France
facility: Research Site
state: Pays De La Loire
city: Nantes
country: France
facility: Research Site 1
state: Pays De La Loire
city: Nantes
country: France
facility: Research Site
state: Pays De La Loire
city: Cannes
country: France
facility: Research Site
state: Provence-Alpes-Côte d'Azur
city: La Crau
country: France
facility: Research Site
state: Provence-Alpes-Côte d'Azur
city: Marseille
country: France
facility: Research Site 1
state: Provence-Alpes-Côte d'Azur
city: Marseille
country: France
facility: Research Site
state: Provence-Alpes-Côte d'Azur
city: Nice
country: France
facility: Research Site
state: Provence-Alpes-Côte d'Azur
city: Toulon
country: France
facility: Research Site
state: Provence-Alpes-Côte d'Azur
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: