One-year Persistence to Treatment of Participants 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].

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Key information

Conditions

Arthritis, Rheumatoid Ankylosis Arthritis Arthritis, Psoriatic Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Colitis Colitis, Ulcerative Colonic Diseases Connective Tissue Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Caluire-et-Cuire, Auvergne-Rhône-Alpes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infliximab

Drug

Administered as specified in the treatment arm.

Other names: Flixabi

Adalimumab

Drug

Administered as specified in the treatment arm.

Other names: Imraldi

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Acronym: PERFUSE

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Sep 10, 2018
Registry last updated: Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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