National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
NCT ID: NCT02925338
Last Updated: 2023-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
1431 participants
OBSERVATIONAL
2016-10-19
2021-04-12
Brief Summary
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Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.
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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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Patients treated with Inflectra
QOL questionaire
Health assessment questionnaire disability index for rheumatoid polyarthritis questionnaire
Interventions
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QOL questionaire
Health assessment questionnaire disability index for rheumatoid polyarthritis questionnaire
Eligibility Criteria
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Inclusion Criteria
* Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it.
* Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.
Exclusion Criteria
* Patients not treated with Inflectra™.
* Patients treated with Inflectra™ for psoriasis.
* Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™.
* Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection .
* Patients with moderate to severe heart failure (NYHA III/IV)
6 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
Strasbourg, Alsace, France
Service de rhumatologie - CHU Nantes, Hopital Hotel Dieu
Nantes, Loire-atlantique, France
Centre Hospitalier Universitaire Gabriel Montpied
Clermont-Ferrand, Puy-de-dôme, France
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, , France
Chi Aix Pertuis
Aix-en-Provence, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Centre Hospitalier Regional de Besancon, Service de Gastrologie
Besançon, , France
CHU Jean Minjoz
Besançon, , France
Hopital Saint Andre - Chu Bordeaux
Bordeaux, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, , France
CHU - Hôpital Pellegrin-tripode
Bordeaux, , France
Clinique Jean Vila
Bruges, , France
Clinique Jean Vilar
Bruges, , France
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
Caen, , France
Centre Hospitalier de Cannes Hopital Pierre Nouveau
Cannes, , France
Centre Hospitalier de Cannes
Cannes, , France
Ch de Cannes Hopital Pierre Nouveau
Cannes, , France
Centre Hospitalier Carcassonne, Service de Rhumatologie
Carcassonne, , France
Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie
Cholet, , France
Centre Hospitalier de Cholet
Cholet, , France
Centre Hospitalier Estaing, Service de Medicine Interne
Clermont-Ferrand, , France
Hopital Beaujon
Clichy, , France
Centre Hospitalier
Contamine Sur Avre, , France
Chu Henri Mondor
Créteil, , France
CHU de Grenoble - Hopital Sud
Échirolles, , France
Hopital Nord
Grenoble, , France
CHU De Grenoble
Grenoble, , France
CHD Vendee
La Roche-sur-Yon, , France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, , France
CHU Grenoble Alpes
La Tronche, , France
Centre Hospitalier de Lille Hopital Roger Salengro
Lille, , France
CHU Limoges - Hôpital Dupuytren
Limoges, , France
Hospital Huriez, CHRU de Lille
Little Cedex, , France
Hopital Saint Philibert
Lomme, , France
Hopital Edouard Herriot Pav H
Lyon, , France
Centre Hospitalier
Metz-Tessy, , France
CHG Montauban
Montauban, , France
Groupe Hospitalier du Havre
Montivilliers, , France
Centre Hospitalier de Montpellier Hopital Saint Eloi
Montpellier, , France
CHU de Montpellier - Saint Eloi
Montpellier, , France
CHU de MONTPELLIER HOPITAL LAPEYRONIE
Montpellier, , France
CHU
Montpellier, , France
CHU Nice-Hopital Archet I
Nice, , France
Hopital de l'Archet
Nice, , France
CHU Nimes
Nîmes, , France
Hopital Cochin
Paris, , France
Hôpital Cochin
Paris, , France
Hopital Claude Bichat
Paris, , France
Hôpital Haut-Lévêque
Pessac, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Hopital Lyon Sud
Pierre-Bénite, , France
Hopital Robert Debre, Service d'Hepato-gastro-enterologie et de Cancerologie Digestive
Reims, , France
Hopital Robert Debre, Service D'Hepato-gastro-enterolo
Reims, , France
CHU de Rouen
Rouen, , France
CHRU Charles Nicolle
Rouen, , France
Service Rhumatologie
Saint-Etienne, , France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, , France
Hopital Nord
Saint-Priest-en-Jarez, , France
Fondation Maison Sante Bagatelle, Gastro Enterologie
Talence, , France
Centre Hospitalier de la Gespe
Tarbes, , France
Hopital du Leman
Thonon-les-Bains, , France
Hopitaux du Leman
Thonon-les-Bains, , France
Hopital Purpan
Toulouse, , France
Hopital Rangueil
Toulouse, , France
Hopital des Hauts Clos
Troyes, , France
Chu Brabois
Vandœuvre-lès-Nancy, , France
Hopital Saint Nicolas
Vitré, , France
Countries
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References
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Marotte H, Cantagrel A, Coury F, Schaeverbeke T, Assing M, Kessouri M, Brault Y, Fautrel B. Real-World Effectiveness and Safety of Infliximab Biosimilar CT-P13 for Rheumatic Diseases: A National Observational Cohort Study (ReFLECT). Adv Ther. 2025 Sep;42(9):4659-4680. doi: 10.1007/s12325-025-03304-6. Epub 2025 Jul 28.
Laharie D, Bouhnik Y, Vuitton L, Biron A, Pierron G, Brault Y, Assing M, Bouzidi A, Amiot A, Nancey S. Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study). Clin Res Hepatol Gastroenterol. 2024 Dec;48(10):102483. doi: 10.1016/j.clinre.2024.102483. Epub 2024 Oct 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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REFLECT
Identifier Type: OTHER
Identifier Source: secondary_id
C1231004
Identifier Type: -
Identifier Source: org_study_id
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