Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
CONNECT-IBD
POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
2 other identifiers
observational
2,565
13 countries
140
Brief Summary
This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:
- To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
- To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
- To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Typical duration for all trials
140 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
Study Start
First participant enrolled
April 22, 2015
CompletedFirst Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedResults Posted
Study results publicly available
February 13, 2020
CompletedFebruary 13, 2020
January 1, 2020
3.5 years
July 22, 2015
October 22, 2019
January 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Disease Characteristics of Participants: Disease Duration
Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline).
Baseline (Day 1)
Number of Participants Who Switched Treatment
Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported.
From baseline to follow-up period (up to a maximum duration of 2 years)
Reasons for Switching Treatment by Participants
From baseline to follow-up period (up to a maximum duration of 2 years)
Total Dose of Infusion Received
Total dose of infusion received by the participants was calculated.
From baseline to follow-up period (up to a maximum duration of 2 years)
Number of Participants by Frequency of Infusion Received
Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories.
Baseline (Day 1)
Number of Participants Who Had Change in Infusion Dose
Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.
From baseline to follow-up period (up to a maximum duration of 2 years)
Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change
Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest \[AESI\]/ serious adverse event \[SAE\]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category.
From baseline to follow-up period (up to a maximum duration of 2 years)
Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)
From baseline to follow-up period (up to a maximum duration of 2 years)
Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.
From baseline to follow-up period (up to a maximum duration of 2 years)
Secondary Outcomes (14)
Number of Participants Remaining in Clinical Remission or Relapse
Months 6, 12, 18 and 24
Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission
Baseline, Months 6, 12, 18 and 24
Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity
Baseline, Months 6, 12, 18 and 24
Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission
Baseline, Months 6, 12, 18 and 24
Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity
Baseline, Months 6, 12, 18 and 24
- +9 more secondary outcomes
Study Arms (2)
CT-P13
biosimilar infliximab
Remicade
infliximab
Interventions
Eligibility Criteria
The target study population will include patients with CD or UC, who are being treated, or initiating treatment, with CT-P13 or Remicade at the time of study enrolment. This would include the following treatment subgroups: * Biologic-naïve patients initiating CT-P13 (or Remicade); * Patients currently being treated with CT-P13 (or Remicade); * Patients who are considered stable by the Investigator under Remicade therapy for CD or UC, who switch to CT-P13; * Patients switching to CT-P13 or Remicade from an alternative biologic therapy (e.g. adalimumab) due to non-responsiveness to or intolerance; * Patients re-initiating CT-P13 or Remicade after having successfully completed and exited a previous course of infliximab therapy in the past. * Patients with fistulating disease or stomas and those receiving combination therapy will be included.
You may qualify if:
- At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.
- Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.
You may not qualify if:
- Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
- Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
- Prior history of failure to respond to Remicade or CT-P13.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Hospira, now a wholly owned subsidiary of Pfizercollaborator
Study Sites (140)
UZ Leuven Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o
Hradec Králové, 500 12, Czechia
Centrum péce o zažívací trakt, Vítkovická nemocnice
Ostrava - Vitkovice, 703 84, Czechia
IKEM (Institut Klinické a Experimentální Medicíny)
Prague, 140 21, Czechia
Nemocnice Na Bulovce
Praha 8 Liben, 180 81, Czechia
Keski-Suomen keskussairaala
Jyväskylä, FI-40620, Finland
Oulu University Hospital
Oulu, 90220, Finland
Turku University Hospital
Turku, 20521, Finland
CHU Amiens
Amiens, 80054, France
CHU Angers
Angers, 49933, France
CHRU de Besancon
Besançon, 25030, France
Centre Hospitalier Universitaire
Caen, 14033, France
Clinique de Bercy
Charenton, 94220, France
CHU Clermontferrand
Clermont-Ferrand, 63003, France
Hopital Beaujon
Clichy, 92110, France
Hôpital Louis Mourier
Colombes, 92700, France
CHU de Grenoble
Grenoble, 38043, France
CHRU
Lille, 59000, France
Hopital Edouard Herriot Pav H
Lyon, 69003, France
Hopital Europeen
Marseille, 13003, France
Hopital Nord
Marseille, 13015, France
CHU
Montpellier, 34295, France
CHU Nimes
Nîmes, 30029/Cedex 9, France
Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie
Paris, 75012, France
Hopital Cochin
Paris, 75014, France
Institut Montsouris
Paris, 75014, France
Hôpital Européen Georges Pompidou
Paris, 75015, France
Hopital St Louis
Paris, 75475, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
Hopital Metz Tessy
Pringy, 74374, France
Hopital Robert Debre
Reims, 51000, France
Chu Ch.Nicolle
Rouen, 76031, France
Service: CHU saint-etienne
Saint Priez En Jarez, 42270, France
Centre Hospitalier Universitaire
Strasbourg, 67098, France
CHU Rangueil
Toulouse, 31059, France
Hopital Purpan
Toulouse, 31059, France
CHU Nancy
Vandœuvre-lès-Nancy, 54511, France
Groupe hospitalier mutualiste les portes du Sud
Vénissieux, 69694, France
St. Marienkrankenhaus
Ludwigshafen am Rhein, Gartenstadt, 67076, Germany
Gemeinschaftspraxis im MEDICUM
Altenholz, 24161, Germany
Gastroenterologische Praxis Dr. med. B. Adami
Alzey, 55232, Germany
Studienzentrum Aschaffenburg
Aschaffenburg, 63739, Germany
Gastroenterologie Am Bayerischen Platz
Berlin, 10825, Germany
Kreiskliniken Altotting-Burghausen
Burghausen, 84489, Germany
Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main
Frankfurt am Main, 60594, Germany
Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner
Friedrichsthal, 66299, Germany
PraxisZentrum fuer Gastroenterologie
Grevenbroich, 41515, Germany
Hamburgisches Forschungsinstitut fur chronisch entzuendliche
Hamburg, 20148, Germany
Gastroenterologische Gemeinschaftspraxis Herne
Herne, 44623, Germany
Internisten am Markt Dres. Schwerdtfeger & Lehmann
Köthen, 06366, Germany
Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen
Leipzig, 04229, Germany
Onco Studies an der Onkologie Dreiländereck
Loerrach, 79539, Germany
Universitaetsmedizin Mannheim
Mannheim, 68135, Germany
Magen-Darm Praxis Prof. Dr. Krammer & Kollegen
Mannheim, 68165, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Praxis Prof.Dr. med. Herbert Kellner
Muenchen-Nymphenburg, 80639, Germany
Medizinisches Versorgungszentrum Portal 10
Münster, 48155, Germany
Gastroenterologische Gemeinschaftspraxis am Germania-Campus
Münster, 48159, Germany
Praxiszentrum Alte Maelzerei
Regensburg, 93053, Germany
Magen-Darm-Zentrum Remscheid
Remscheid, 42859, Germany
Zentrum für Gastroenterologie Saarbrücken MVZ GmbH
Saarbrücken, 66111, Germany
Ambulanzzentrum-Schweinfurt
Schweinfurt, 97421, Germany
Gastroenterologische Schwerpunktpraxis Stuttgart
Stuttgart, 70178, Germany
University Hospital of Patras
Rio, Patra, Achaia, 265 04, Greece
Hippokration General Hospital of Athens
Athens, Attica, 11527, Greece
Venizeleio Hospital of Heraklion
Heraklion, Crete, 71409, Greece
Evangelismos Hospital
Athens, 10676, Greece
University Hospital of Ioannina
Ioannina, 455 00, Greece
University Hospital of Larissa
Larissa, 41110, Greece
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, 54642, Greece
Semmelweis University
Budapest, H-1088, Hungary
MH Egeszsegugyi Kozpont - Honvedkorhaz
Budapest, H-1134, Hungary
Szte szent-gyorgyi albert klinikai kozpont
Szeged, H-6725, Hungary
Presidio Ospedaliero "M. Raimondi"
San Cataldo (Caltanisetta), Caltanisetta, 93100, Italy
ASL 11 Empoli - Ospedale San Giuseppe
Empoli, FI, 50053, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, FI, 50134, Italy
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126, Italy
Ospedale "Sacro Cuore - Don Calabria"
Negrar, Verona, 27024, Italy
Fondazione Poliambulanza - Istituto Ospedaliero
Brescia, 25124, Italy
Azienda Ospedaliera per l'Emergenza Cannizzaro
Catania, 95100, Italy
Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"
Catania, 95123, Italy
Università degli Studi "G. d'Annunzio" Chieti - Pescara
Chieti, 66100, Italy
ASUR Area Vasta n. 4 - Ospedale A. Murri
Fermo, 63900, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Università degli Studi di Genova
Genova, 16132, Italy
Ospedale Generale Provinciale di Macerata
Macerata, 62100, Italy
A.O.U. Policlinico "G.Martino"
Messina, 98125, Italy
Azienda Ospedaliera - Universitaria di Modena Policlinico
Modena, 41124, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello
Palermo, 90146, Italy
AOUP - Ospedale di Cisanello
Pisa, 56124, Italy
Azienda Ospedaliera Universitaria di PISA
Pisa, 56124, Italy
Ospedale Sandro Pertini
Roma, 00157, Italy
Ospedale San Camillo
Rome, 00152, Italy
A.O.U. "S. Maria della Misericordia di Udine"
Udine, 33100, Italy
Ziekenhuis Gelderse Vallei
Ede, 6716 RP, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623, Netherlands
Rijnstate
Gelderland, 6815 AD, Netherlands
Hospital Prof. Doutor Fernando Fonseca E.P.E
Amadora, Lisbon District, 2720-276, Portugal
Centro Hospitalar entre Douro e Vouga E.P.E.
Santa Maria Da Feira, Porto District, 4520-211, Portugal
Centro Hospitalar Barreiro Montijo, E.P.E
Barreiro, 2830-003, Portugal
Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria
Lisbon, 1649-035, Portugal
FNsP F. D. Roosevelta Banska Bystrica
Banská Bystrica, 974 01, Slovakia
V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia
Bratislava, 826 06, Slovakia
Hospital Arquitecto Marcide
Ferrol, A Coruna, 15405, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Son Espases
Palma. Mallorca, Balearic Islands, 07120, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Barcelona, 17007, Spain
Hospital de Sabadell
Sabadell, Barcelona, 08208, Spain
Hospital de Galdakao
Usansolo, Bizkaia, 48960, Spain
Hospital Universitario de Gran Canaria DR NEGRIN
Las Palmas de Gran Canari, Canary Islands, 35010, Spain
Hospital de Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Universitario Infanta Sofia
San Sebastian de Los Reye, Madrid, 28702, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Alvaro Cunqueiro
Pontevedra, 36312, Spain
Hospital Clínico de Valencia
Valencia, 46010, Spain
Consorci Hospital General Universitari de Valencia
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47005, Spain
Royal Gwent Hospital
Exeter, Devon, EX2 5DW, United Kingdom
Dorset County Hospital
Dorchester, Dorset, DT1 2JY, United Kingdom
Gloucestershire Hospitals - NHS Foundation Trust
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Cwm Taf University Health Board
Llantrisant, Wales, CF72 8XR, United Kingdom
University Hospital Coventry
Coventry, WEST Midlands, CV2 2DX, United Kingdom
Salisbury NHS Foundation Trust
Salisbury, Wiltshire, SP2 8BJ, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, B9 5SS, United Kingdom
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Queen Alexandra Hospital
Hampshire, PO6 3LY, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Bokemeyer B, Hlavaty T, Allez M, Selema P, Moosavi S, Cadatal MJ, Fowler H, Mueller M, Liau KF, Gisbert JP. Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD). Expert Opin Biol Ther. 2023 Jul-Dec;23(8):791-800. doi: 10.1080/14712598.2023.2200883. Epub 2023 Apr 16.
PMID: 37038897DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
July 22, 2015
First Posted
September 3, 2015
Study Start
April 22, 2015
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
February 13, 2020
Results First Posted
February 13, 2020
Record last verified: 2020-01
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.