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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03662919
Date of registration: 06/09/2018
Prospective Registration: Yes
Primary sponsor: Biogen
Public title: One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study PERFUSE
Scientific title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study
Date of first enrolment: July 2, 2018
Target sample size: 3000
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03662919
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
France
Contacts
Name:     US Biogen Clinical Trial Center
Address: 
Telephone: 866-633-4636
Email: clinicaltrials@biogen.com
Affiliation: 
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Biogen
Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis, Psoriatic
Arthritis, Rheumatoid
Colitis, Ulcerative
Crohn's Disease
Spondylitis, Ankylosing
Intervention(s)
Drug: Adalimumab
Drug: Infliximab
Primary Outcome(s)
Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months [Time Frame: Up to 12 months]
Secondary Outcome(s)
Secondary ID(s)
2017-A03220-53
FRA-FLX-17-11226
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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