One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study
NCT ID: NCT03662919
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2274 participants
OBSERVATIONAL
2018-07-02
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Infliximab
Administered as specified in the treatment arm.
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.
Adalimumab
Administered as specified in the treatment arm.
Interventions
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Infliximab
Administered as specified in the treatment arm.
Adalimumab
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Participant who are not to be followed up in the same investigator site for 2 years after baseline.
6 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
Research Site 1
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
Research Site
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
Research Site
Lyon, Auvergne-Rhône-Alpes, France
Research Site 1
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Research Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Research Site
Saint-Etienne, Auvergne-Rhône-Alpes, France
Research Site
Dijon, Bourgogne-Franche-Comté, France
Research Site 1
Brest, Brittany Region, France
Research Site
Brest, Brittany Region, France
Research Site
Rennes, Brittany Region, France
Research Site
Chambray-lès-Tours, Centre-Val de Loire, France
Research Site
Orléans, Centre-Val de Loire, France
Research Site
Reims, Grand Est, France
Research Site
Strasbourg, Grand Est, France
Research Site 1
Vandœuvre-lès-Nancy, Grand Est, France
Research Site
Vandœuvre-lès-Nancy, Grand Est, France
Research Site
Amiens, Hauts-de-France, France
Research Site 1
Lille, Hauts-de-France, France
Research Site
Lille, Hauts-de-France, France
Research Site
Caen, Normandy, France
Research Site
Rouen, Normandy, France
Research Site
Bayonne, Nouvelle-Aquitaine, France
Research Site
Bordeaux, Nouvelle-Aquitaine, France
Research Site 1
La Rochelle, Nouvelle-Aquitaine, France
Research Site 2
La Rochelle, Nouvelle-Aquitaine, France
Research Site
La Rochelle, Nouvelle-Aquitaine, France
Research Site
Limoges, Nouvelle-Aquitaine, France
Research Site 1
Montpellier, Occitanie, France
Research Site
Montpellier, Occitanie, France
Research Site 1
Nîmes, Occitanie, France
Research Site
Nîmes, Occitanie, France
Research Site 1
Toulouse, Occitanie, France
Research Site
Toulouse, Occitanie, France
Research Site
Angers, Pays de la Loire Region, France
Research Site 1
Nantes, Pays de la Loire Region, France
Research Site
Nantes, Pays de la Loire Region, France
Research Site
Cannes, Provence-Alpes-Côte d'Azur Region, France
Research Site
La Crau, Provence-Alpes-Côte d'Azur Region, France
Research Site 1
Marseille, Provence-Alpes-Côte d'Azur Region, France
Research Site
Marseille, Provence-Alpes-Côte d'Azur Region, France
Research Site
Nice, Provence-Alpes-Côte d'Azur Region, France
Research Site
Toulon, Provence-Alpes-Côte d'Azur Region, France
Research Site 1
Bobigny, Île-de-France Region, France
Research Site
Bobigny, Île-de-France Region, France
Research Site
Clichy, Île-de-France Region, France
Research Site
Colombes, Île-de-France Region, France
Research Site
Créteil, Île-de-France Region, France
Research Site
Le Kremlin-Bicêtre, Île-de-France Region, France
Research Site 10
Paris, Île-de-France Region, France
Research Site 1
Paris, Île-de-France Region, France
Research Site 2
Paris, Île-de-France Region, France
Research Site 3
Paris, Île-de-France Region, France
Research Site 4
Paris, Île-de-France Region, France
Research Site 5
Paris, Île-de-France Region, France
Research Site 6
Paris, Île-de-France Region, France
Research Site 7
Paris, Île-de-France Region, France
Research Site 8
Paris, Île-de-France Region, France
Research Site 9
Paris, Île-de-France Region, France
Research Site
Paris, Île-de-France Region, France
Countries
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References
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Fautrel B, Bouhnik Y, Salliot C, Carbonnel F, Fumery M, Bernardeau C, Maugars Y, Flamant M, Coury F, Braithwaite B, Hateb S, Addison J; PERFUSE investigators. Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study. Drugs Real World Outcomes. 2024 Dec;11(4):573-591. doi: 10.1007/s40801-024-00459-6. Epub 2024 Oct 10.
Fautrel B, Bouhnik Y, Dieude P, Richette P, Dougados M, Freudensprung U, Brigui A, Addison J. Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study. Rheumatol Adv Pract. 2023 Apr 17;7(2):rkad031. doi: 10.1093/rap/rkad031. eCollection 2023.
Martinez-Vinson C, Lemoine A, Bouhnik Y, Braithwaite B, Fohlen-Weill A, Addison J. PERFUSE: Non-Interventional Cohort Study of Patients Receiving Infliximab Biosimilar SB2: Results in Pediatric Patients. J Pediatr Gastroenterol Nutr. 2023 Apr 1;76(4):451-459. doi: 10.1097/MPG.0000000000003683. Epub 2022 Dec 16.
Other Identifiers
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2017-A03220-53
Identifier Type: REGISTRY
Identifier Source: secondary_id
FRA-FLX-17-11226
Identifier Type: -
Identifier Source: org_study_id
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