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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03220-53 | Registry Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion/ Exclusion Criteria
Key Inclusion Criteria:
Adult participant (18 years and over)
Paediatric participants (6-17 years):
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Caluire-et-Cuire | Auvergne-Rhône-Alpes | France | |||
| Research Site 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39384685 | Derived | 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. | |
| 37122809 |
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| Adalimumab | Drug | Administered as specified in the treatment arm. |
|
|
| 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 | Bayonne | New Aquitaine | France |
| Research Site | Bordeaux | New Aquitaine | France |
| Research Site 1 | La Rochelle | New Aquitaine | France |
| Research Site 2 | La Rochelle | New Aquitaine | France |
| Research Site | La Rochelle | New Aquitaine | France |
| Research Site | Limoges | New Aquitaine | France |
| Research Site | Caen | Normandy | France |
| Research Site | Rouen | Normandy | 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 |
| 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. |
| 36729422 | 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. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
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