National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
ReFLECT
OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.
2 other identifiers
observational
1,431
1 country
67
Brief Summary
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2021
CompletedResults Posted
Study results publicly available
January 25, 2023
CompletedJanuary 25, 2023
January 1, 2023
4.5 years
October 4, 2016
April 11, 2022
January 6, 2023
Conditions
Outcome Measures
Primary Outcomes (10)
Percentage of Participants Without Treatment Failure During 2-Years of Observation
Treatment failure was defined as permanent discontinuation of the Inflectra treatment due to intolerance and/or permanent discontinuation of treatment due to absence of response according to the physician's assessment, or death of the participant related to Inflectra. In this outcome measure percentage of participants without treatment failure and whose data were missing are reported.
2 years post inclusion in the study
Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy
Pre-treatment assessment was a check-list with the set of measures determined by the physician to check the eligibility of a participant before initiation of treatment. Physician recorded as "Yes" if a participant was eligible for initiation of treatment and "No" if a participant was not eligible to initiate a treatment. In this outcome measure, number of participants whose pre-treatment assessment were performed prior to initiation of Inflectra are reported and whose data were missing are reported.
Data collected and recorded at study inclusion visit
Time Between Diagnosis and Inclusion in Study
Data collected and recorded at study inclusion visit
Time Between Diagnosis and the First Inflectra Infusion
Data collected and recorded at study inclusion visit
Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study
Type of biotherapies received by participants before inclusion in the study were: anti-TNF alpha (remicade/ adalimumab/ golimumab / etanercept/ rituximab); anti-integrin (vedolizumab); immunosuppressant (abatacept); interleukin inhibitor (anakinra / tocilizumab); anti interleukin (IL) 12 and anti IL-23 (ustekinumab); and other. In this outcome measure number of participants who received biotherapies other than Inflectra and whose data were missing are reported.
Data collected and recorded at study inclusion visit
Number of Participants With Reasons for Discontinuation of Previous Biotherapy
Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure, number of participants who discontinued previous biotherapy are reported according to reason of discontinuations.
Data collected and recorded at study inclusion visit
Duration of Previous Biotherapies
Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other.
Data collected and recorded at study inclusion visit
Mean of Number of Doses Administered in Previous Biotherapy
Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure mean of number of doses administered in previous biotherapy is reported.
Data collected and recorded at study inclusion visit
Last Dosage Administered of a Previous Biotherapy
Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure mean of last dosage (in units) of previous biotherapy administered dose is reported.
Data collected and recorded at study inclusion visit
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra
Following concomitant treatments were received by participants before initiation of Inflectra: 1) Corticosteroids, 2) Salicylates, and 3) Azathioprine/6-MP, Methotrexate, and Cyclosporine.
Data collected and recorded at study inclusion visit
Secondary Outcomes (31)
Physician Global Assessment (PGA) of Disease for RA, SpA and PA
24 months
Mean Administered Dose of Inflectra (in mg)
Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
Mean Administered Posology of Inflectra (in mg/kg)
Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
Cumulative Dose
Inclusion visit up to 6-Month visit, Inclusion visit up to 12-Month visit, Inclusion visit up to 18-Month visit, and Inclusion visit up to 24-Month visit
Mean Infusion Time
Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
- +26 more secondary outcomes
Study Arms (1)
Patients treated with Inflectra
Interventions
Health assessment questionnaire disability index for rheumatoid polyarthritis questionnaire
Eligibility Criteria
Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. 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
You may qualify if:
- Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
- 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.
You may not qualify if:
- Patients who refuse access to their medical file for collection of: their medical data
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (67)
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
Strasbourg, Alsace, 67098, France
Service de rhumatologie - CHU Nantes, Hopital Hotel Dieu
Nantes, Loire-atlantique, 44093, France
Centre Hospitalier Universitaire Gabriel Montpied
Clermont-Ferrand, Puy-de-dôme, 63003, France
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616, France
Chi Aix Pertuis
Aix-en-Provence, 13616, France
Centre Hospitalier de la Cote Basque
Bayonne, 64109, France
Centre Hospitalier Regional de Besancon, Service de Gastrologie
Besançon, 25030, France
CHU Jean Minjoz
Besançon, 25030, France
Hopital Saint Andre - Chu Bordeaux
Bordeaux, 33075 Cedex, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, 33076, France
CHU - Hôpital Pellegrin-tripode
Bordeaux, 33076, France
Clinique Jean Vila
Bruges, 33520, France
Clinique Jean Vilar
Bruges, 33523, France
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
Caen, 14033, France
Centre Hospitalier de Cannes Hopital Pierre Nouveau
Cannes, 06414, France
Centre Hospitalier de Cannes
Cannes, 06414, France
Ch de Cannes Hopital Pierre Nouveau
Cannes, 06414, France
Centre Hospitalier Carcassonne, Service de Rhumatologie
Carcassonne, 11000, France
Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie
Cholet, 49325, France
Centre Hospitalier de Cholet
Cholet, 49325, France
Centre Hospitalier Estaing, Service de Medicine Interne
Clermont-Ferrand, 63100, France
Hopital Beaujon
Clichy, 92110, France
Centre Hospitalier
Contamine Sur Avre, 74130, France
Chu Henri Mondor
Créteil, 94000, France
CHU de Grenoble - Hopital Sud
Échirolles, 38434, France
Hopital Nord
Grenoble, 38043, France
CHU De Grenoble
Grenoble, 38700, France
CHD Vendee
La Roche-sur-Yon, 85000, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700, France
CHU Grenoble Alpes
La Tronche, 38700, France
Centre Hospitalier de Lille Hopital Roger Salengro
Lille, 59037, France
CHU Limoges - Hôpital Dupuytren
Limoges, 87042, France
Hospital Huriez, CHRU de Lille
Little Cedex, 59037, France
Hopital Saint Philibert
Lomme, 59160, France
Hopital Edouard Herriot Pav H
Lyon, 69003, France
Centre Hospitalier
Metz-Tessy, 74370, France
CHG Montauban
Montauban, 82013, France
Groupe Hospitalier du Havre
Montivilliers, 76290, France
Centre Hospitalier de Montpellier Hopital Saint Eloi
Montpellier, 34090, France
CHU de Montpellier - Saint Eloi
Montpellier, 34090, France
CHU de MONTPELLIER HOPITAL LAPEYRONIE
Montpellier, 34295, France
CHU
Montpellier, 34295, France
CHU Nice-Hopital Archet I
Nice, 06200, France
Hopital de l'Archet
Nice, 06202, France
CHU Nimes
Nîmes, 30029, France
Hopital Cochin
Paris, 75014, France
Hôpital Cochin
Paris, 75014, France
Hopital Claude Bichat
Paris, 75877, France
Hôpital Haut-Lévêque
Pessac, 33604, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
Hopital Lyon Sud
Pierre-Bénite, 69495, France
Hopital Robert Debre, Service d'Hepato-gastro-enterologie et de Cancerologie Digestive
Reims, 51092, France
Hopital Robert Debre, Service D'Hepato-gastro-enterolo
Reims, 51092, France
CHU de Rouen
Rouen, 76000, France
CHRU Charles Nicolle
Rouen, 76031, France
Service Rhumatologie
Saint-Etienne, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Fondation Maison Sante Bagatelle, Gastro Enterologie
Talence, 33401, France
Centre Hospitalier de la Gespe
Tarbes, 65013, France
Hopital du Leman
Thonon-les-Bains, 74200, France
Hopitaux du Leman
Thonon-les-Bains, 74203, France
Hopital Purpan
Toulouse, 31059, France
Hopital Rangueil
Toulouse, 31403, France
Hopital des Hauts Clos
Troyes, 10003, France
Chu Brabois
Vandœuvre-lès-Nancy, 54511, France
Hopital Saint Nicolas
Vitré, 35506, France
Related Publications (2)
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.
PMID: 40720061DERIVEDLaharie 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.
PMID: 39448029DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 5, 2016
Study Start
October 19, 2016
Primary Completion
April 12, 2021
Study Completion
April 12, 2021
Last Updated
January 25, 2023
Results First Posted
January 25, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.