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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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