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

October 17, 2022 updated by: Biogen

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

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].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne-Rhône-Alpes
      • Caluire et Cuire, Auvergne-Rhône-Alpes, France
        • Research Site
      • Clermont-Ferrand, Auvergne-Rhône-Alpes, France
        • Research Site 1
      • Clermont-Ferrand, Auvergne-Rhône-Alpes, France
        • Research Site
      • Lyon, Auvergne-Rhône-Alpes, France
        • Research Site
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France
        • Research Site 1
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France
        • Research Site
      • Saint-Etienne, Auvergne-Rhône-Alpes, France
        • Research Site
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France
        • Research Site
    • Bretagne
      • Brest, Bretagne, France
        • Research Site 1
      • Brest, Bretagne, France
        • Research Site
      • Rennes, Bretagne, France
        • Research Site
    • Centre-Val De Loire
      • Chambray les Tours, Centre-Val De Loire, France
        • Research Site
      • Orléans, Centre-Val De Loire, France
        • Research Site
    • Grand Est
      • Reims, Grand Est, France
        • Research Site
      • Strasbourg, Grand Est, France
        • Research Site
      • Vandoeuvre-lès-Nancy, Grand Est, France
        • Research Site 1
      • Vandoeuvre-lès-Nancy, Grand Est, France
        • Research Site
    • Hauts-de-France
      • Amiens, Hauts-de-France, France
        • Research Site
      • Lille, Hauts-de-France, France
        • Research Site 1
      • Lille, Hauts-de-France, France
        • Research Site
    • Ile De France
      • Bobigny, Ile De France, France
        • Research Site 1
      • Bobigny, Ile De France, France
        • Research Site
      • Clichy, Ile De France, France
        • Research Site
      • Colombes, Ile De France, France
        • Research Site
      • Créteil, Ile De France, France
        • Research Site
      • Le Kremlin-Bicêtre, Ile De France, France
        • Research Site
      • Paris, Ile De France, France
        • Research Site 10
      • Paris, Ile De France, France
        • Research Site 1
      • Paris, Ile De France, France
        • Research Site 2
      • Paris, Ile De France, France
        • Research Site 3
      • Paris, Ile De France, France
        • Research Site 4
      • Paris, Ile De France, France
        • Research Site 5
      • Paris, Ile De France, France
        • Research Site 6
      • Paris, Ile De France, France
        • Research Site 7
      • Paris, Ile De France, France
        • Research Site 8
      • Paris, Ile De France, France
        • Research Site 9
      • Paris, Ile De France, France
        • Research Site
    • Normandie
      • Caen, Normandie, France
        • Research Site
      • Rouen, Normandie, France
        • Research Site
    • Nouvelle-Aquitaine
      • Bayonne, Nouvelle-Aquitaine, France
        • Research Site
      • Bordeaux, Nouvelle-Aquitaine, France
        • Research Site
      • La Rochelle, Nouvelle-Aquitaine, France
        • Research Site 1
      • La Rochelle, Nouvelle-Aquitaine, France
        • Research Site 2
      • La Rochelle, Nouvelle-Aquitaine, France
        • Research Site
      • Limoges, Nouvelle-Aquitaine, France
        • Research Site
    • Occitanie
      • Montpellier, Occitanie, France
        • Research Site 1
      • Montpellier, Occitanie, France
        • Research Site
      • Nîmes, Occitanie, France
        • Research Site 1
      • Nîmes, Occitanie, France
        • Research Site
      • Toulouse, Occitanie, France
        • Research Site 1
      • Toulouse, Occitanie, France
        • Research Site
    • Pays De La Loire
      • Angers, Pays De La Loire, France
        • Research Site
      • Nantes, Pays De La Loire, France
        • Research Site 1
      • Nantes, Pays De La Loire, France
        • Research Site
    • Provence-Alpes-Côte d'Azur
      • Cannes, Provence-Alpes-Côte d'Azur, France
        • Research Site
      • La Crau, Provence-Alpes-Côte d'Azur, France
        • Research Site
      • Marseille, Provence-Alpes-Côte d'Azur, France
        • Research Site 1
      • Marseille, Provence-Alpes-Côte d'Azur, France
        • Research Site
      • Nice, Provence-Alpes-Côte d'Azur, France
        • Research Site
      • Toulon, Provence-Alpes-Côte d'Azur, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Infliximab
Administered as specified in the treatment arm.
Other Names:
  • Flixabi
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.
Drug: Adalimumab
Administered as specified in the treatment arm.
Other Names:
  • Imraldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months
Time Frame: Up to 12 months
Percentage of participants, either infliximab naïve or switched from Remicade or CT-P13 to Flixabi, who are still treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi, who are still treated with Imraldi, at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults for both treatments and children only for Flixabi) will be reported.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRA-FLX-17-11226
  • 2017-A03220-53 (Registry Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Rheumatoid

Clinical Trials on Infliximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe