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

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ClinicalTrials.gov Identifier: NCT03662919
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

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].

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Spondylitis, Ankylosing Arthritis, Psoriatic Crohn's Disease Colitis, Ulcerative Drug: Infliximab Drug: Adalimumab

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Imraldi




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662919


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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France
Research Site Recruiting
Bobigny, France
Research Site Recruiting
Clichy, France
Research Site Recruiting
Creteil, France
Research Site Recruiting
Paris, France, 75013
Research Site 1 Recruiting
Paris, France
Research Site 2 Recruiting
Paris, France
Research Site 3 Recruiting
Paris, France
Research Site 4 Recruiting
Paris, France
Research Site 5 Recruiting
Paris, France
Research Site 6 Recruiting
Paris, France
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03662919    
Other Study ID Numbers: FRA-FLX-17-11226
2017-A03220-53 ( Registry Identifier: ID-RCB )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Crohn Disease
Colitis, Ulcerative
Joint Diseases
Musculoskeletal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis