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

NCT03662919 | Completed FDA Drug

• 2 other identifiers: FRA-FLX-17-112262017-A03220-53
• Study Type: observational
• Target: 2,274
• Locations: 1 country
• Sites: 60

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) \[adults for both treatments and children only for Flixabi\].

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Crohn's Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 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

Study Arms (2)

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

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

Interventions

Infliximab DRUG

Administered as specified in the treatment arm.

Also known as: Flixabi

Flixabi

Adalimumab DRUG

Administered as specified in the treatment arm.

Also known as: Imraldi

Imraldi

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.
• Participant treated for psoriasis.
• Participant who are not to be followed up in the same investigator site for 2 years after baseline.

Sponsors & Collaborators

• Biogen: lead

Study Sites (60)

Research Site

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

Location

Research Site 1

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

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Clermont-Ferrand, Auvergne-Rhône-Alpes, France

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Lyon, Auvergne-Rhône-Alpes, France

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Research Site 1

Pierre-Bénite, Auvergne-Rhône-Alpes, France

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Pierre-Bénite, Auvergne-Rhône-Alpes, France

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Saint-Etienne, Auvergne-Rhône-Alpes, France

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Dijon, Bourgogne-Franche-Comté, France

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Research Site 1

Brest, Brittany Region, France

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Brest, Brittany Region, France

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Rennes, Brittany Region, France

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Chambray-lès-Tours, Centre-Val de Loire, France

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Orléans, Centre-Val de Loire, France

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Reims, Grand Est, France

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Strasbourg, Grand Est, France

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Research Site 1

Vandœuvre-lès-Nancy, Grand Est, France

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Vandœuvre-lès-Nancy, Grand Est, France

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Amiens, Hauts-de-France, France

Location

Research Site 1

Lille, Hauts-de-France, France

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Lille, Hauts-de-France, France

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Caen, Normandy, France

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Rouen, Normandy, France

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Bayonne, Nouvelle-Aquitaine, France

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Bordeaux, Nouvelle-Aquitaine, France

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La Rochelle, Nouvelle-Aquitaine, France

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Research Site 2

La Rochelle, Nouvelle-Aquitaine, France

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La Rochelle, Nouvelle-Aquitaine, France

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Limoges, Nouvelle-Aquitaine, France

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Research Site 1

Montpellier, Occitanie, France

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Montpellier, Occitanie, France

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Research Site 1

Nîmes, Occitanie, France

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Nîmes, Occitanie, France

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Research Site 1

Toulouse, Occitanie, France

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Toulouse, Occitanie, France

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Angers, Pays de la Loire Region, France

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Research Site 1

Nantes, Pays de la Loire Region, France

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Nantes, Pays de la Loire Region, France

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Cannes, Provence-Alpes-Côte d'Azur Region, France

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La Crau, Provence-Alpes-Côte d'Azur Region, France

Location

Research Site 1

Marseille, Provence-Alpes-Côte d'Azur Region, France

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Marseille, Provence-Alpes-Côte d'Azur Region, France

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Nice, Provence-Alpes-Côte d'Azur Region, France

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Toulon, Provence-Alpes-Côte d'Azur Region, France

Location

Research Site 1

Bobigny, Île-de-France Region, France

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Bobigny, Île-de-France Region, France

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Clichy, Île-de-France Region, France

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Colombes, Île-de-France Region, France

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Créteil, Île-de-France Region, France

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Le Kremlin-Bicêtre, Île-de-France Region, France

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Research Site 10

Paris, Île-de-France Region, France

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Research Site 1

Paris, Île-de-France Region, France

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Research Site 2

Paris, Île-de-France Region, France

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Research Site 3

Paris, Île-de-France Region, France

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Research Site 4

Paris, Île-de-France Region, France

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Research Site 5

Paris, Île-de-France Region, France

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Research Site 6

Paris, Île-de-France Region, France

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Research Site 7

Paris, Île-de-France Region, France

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Research Site 8

Paris, Île-de-France Region, France

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Research Site 9

Paris, Île-de-France Region, France

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Research Site

Paris, Île-de-France Region, France

Location

Related Publications (3)

• 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.

  PMID: 39384685 DERIVED

• 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.

  PMID: 37122809 DERIVED

• 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.

  PMID: 36729422 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: July 2, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

FR (60)