Last updated on December 2018

A clinical trial to evaluate treatments using Inflectra (infliximab) for patients with Ulcerative Colitis, Inflammatory bowel disease, Crohn's Disease


Brief description of study

This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed Inflectra (infliximab) or Remicade (infliximab) for treatment. Inflectra 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 Inflectra for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
  • To assess the safety of Inflectra up to a 2-year follow-up period in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To assess the effectiveness of Inflectra in the treatment of patients with CD or UC in the context of standard of care Remicade
  • To evaluate the immunogenicity profile of Inflectra in the treatment of patients with CD or UC
  • To evaluate patient-reported outcomes (PRO) including quality of life (QoL), work productivity and healthcare resource utilization (HRU) in patients treated with Inflectra for CD or UC

Detailed Study Description

The study will be conducted according to good clinical practice (GCP) guidelines and data source will be validated. The source data will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into an web based electronic data capture (EDC) system at enrolment and then approximately every 3 months thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be of 3300 patients recruited over 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.

Clinical Study Identifier: NCT02539368

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UZ Leuven Campus Gasthuisberg
Leuven, Belgium

Marcela Kopacova University Hospital
Hradec Kralove, Czechia

HEPATO-GASTROENTEROLOGIE HK, s.r.o
Hradec Kralove, Czechia

Centrum p ce o za vac trakt, V tkovick nemocnice
Ostrava - Vitkovice, Czechia

IKEM
Prague, Czechia

Nemocnice Na Bulovce
Praha 8 Liben, Czechia

Keski-Suomen keskussairaala
Jyvaskyla, Finland

Oulu University Hospital
Oulu, Finland

Turku University Hospital
Turku, Finland

CHU Amiens
Amiens, France

CHU Angers
Angers, France

CHRU de Besancon
Besancon, France

Centre Hospitalier Universitaire
Caen, France

Clinique de Bercy
Charenton, France

CHU Clermontferrand
Clermont-ferrand, France

Hopital Beaujon
Clichy, France

H pital Louis Mourier
Colombes, France

CHU de Grenoble
Grenoble, France

CHRU
Lille, France

Hopital Edouard Herriot Pav H
Lyon, France

Hopital Europeen
Marseille, France

Hopital Nord
Marseille, France

CHU
Montpellier, France

CHU Nimes
Nimes, France

H pital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie
Paris, France

Hopital Cochin
Paris, France

Institut Montsouris
Paris, France

H pital Europ en Georges Pompidou
Paris, France

Hopital St Louis
Paris, France

Hopital Metz Tessy
Pringy, France

Hopital Robert Debre
Reims, France

Chu Ch.Nicolle
Rouen, France

Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint Priest en Jarez, France

Centre Hospitalier Universitaire
Strasbourg, France

CHU Rangueil
Toulouse, France

Hopital Purpan
Toulouse, France

CHU Nancy
Vandoeuvre les Nancy, France

Groupe hospitalier mutualiste les portes du Sud
Venissieux, France

Gemeinschaftspraxis im MEDICUM
Altenholz, Germany

Studienzentrum Aschaffenburg
Aschaffenburg, Germany

Gastroenterologie Am Bayerischen Platz
Berlin, Germany

Kreiskliniken Altotting-Burghausen
Burghausen, Germany

Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main
Frankfurt am Main, Germany

Gemeinschaftspraxis Dr. med. Ralf Denger und Dr. med. Armin Sammler
Friedrichsthal, Germany

PraxisZentrum fuer Gastroenterologie
Grevenbroich, Germany

Hamburgisches Forschungsinstitut fur chronisch entzuendliche
Hamburg, Germany

Gastroenterologische Gemeinschaftspraxis Herne
Herne, Germany

Internisten am Markt Dres. Schwerdtfeger & Lehmann
Koethen, Germany

Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen
Leipzig, Germany

St. Marienkrankenhaus Medizinische Klinik I
Ludwigshafen am Rhein, Germany

Universitaetsmedizin Mannheim
Mannheim, Germany

Magen-Darm Praxis Prof. Dr. Krammer & Kollegen
Mannheim, Germany

Gastroenterologische Gemeinschaftspraxis Minden
Minden, Germany

Praxis Prof.Dr. med. Herbert Kellner
Muenchen-Nymphenburg, Germany

Medizinisches Versorgungszentrum Portal 10
Muenster, Germany

Gastroenterologische Gemeinschaftspraxis am Germania-Campus
Muenster, Germany

Praxiszentrum Alte Maelzerei
Regensburg, Germany

Schwerpunktpraxis Gastroenterologie Remscheid
Remscheid, Germany

Gemeinschaftspraxis - Endoskopiezentrum M. Hasenstein / Dr. W. Mohl
Saarbrucken, Germany

Ambulanzzentrum-Schweinfurt
Schweinfurt, Germany

Gastroenterologische Schwerpunktpraxis Stuttgart
Stuttgart, Germany

University Hospital of Patras
Rio, Patra, Greece

Venizeleio Hospital of Heraklion
Heraklion, Greece

Evangelismos Hospital
Athens, Greece

General Hospital of Thessaloniki Ippokrateio
Thessaloniki, Greece

Semmelweis University
Budapest, Hungary

MH Egeszsegugyi Kozpont - Honvedkorhaz
Budapest, Hungary

Szte szent-gyorgyi albert klinikai kozpont
Szeged, Hungary

Presidio Ospedaliero M. Raimondi
San Cataldo (Caltanisetta), Italy

ASL 11 Empoli - Ospedale San Giuseppe
Empoli, Italy

Azienda Ospedaliero Universitaria Careggi
Firenze, Italy

I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Italy

Azienda Ospedaliero-Universitaria di Parma
Parma, Italy

Ospedale "Sacro Cuore - Don Calabria
Negrar, Italy

Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy

Azienda Ospedaliera per l'Emergenza Cannizzaro
Catania, Italy

Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"
Catania, Italy

ASUR Area Vasta n. 4 - Ospedale A. Murri
Fermo, Italy

Azienda Ospedaliera Universitaria Careggi
Firenze, Italy

Universit degli Studi di Genova
Genova, Italy

Ospedale Generale Provinciale di Macerata
Macerata, Italy

A.O.U. Policlinico "G.Martino"
Messina, Italy

Azienda Ospedaliera - Universitaria di Modena Policlinico
Modena, Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy

Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello
Palermo, Italy

Azienda Ospedaliera Universitaria di PISA
Pisa, Italy

Azienda Ospedaliero Universitaria Pisana
Pisa, Italy

Ospedale San Camillo
Rome, Italy

Ziekenhuis Gelderse Vallei
Ede, Netherlands

Catharina Ziekenhuis
Eindhoven, Netherlands

Rijnstate
Gelderland, Netherlands

Hospital Prof. Doutor Fernando Fonseca
Amadora, Portugal

Centro Hospitalar entre Douro e Vouga
Santa Maria da Feira, Portugal

Centro Hospitalar Barreiro Montejo
Barreiro, Portugal

Hospital Santa Maria
Lisboa, Portugal

FNsP F. D. Roosevelta Banska Bystrica
Banska Bystrica, Slovakia

V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia
Bratislava, Slovakia

Hospital Arquitecto Marcide
Ferrol, Spain

Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain

Hospital Universitari Germans Trias i Pujol
Badalona, Spain

Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain

Hospital de Sabadell
Sabadell, Spain

Hospital de Galdakano
Usansolo, Spain

Pfizer CT.gov Call Center

Hospital Universitario de Gran Canaria DR NEGRIN
Las Palmas de Gran Canari, Spain

Hospital Son Espases
Palma. Mallorca, Spain

Hospital de Alcorcon
Alcorcon, Spain

Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain

Pfizer CT.gov Call Center

Hospital Universitario Infanta Sofia
San Sebastian de los Reye, Spain

Complejo Hospitalario de Navarra
Pamplona, Spain

Hospital Universitario La Princesa
Madrid, Spain

Hospital Universitario Gregorio Mara on
Madrid, Spain

Hospital Ramon y Cajal
Madrid, Spain

Hospital Clinico San Carlos
Madrid, Spain

Hospital Fundaci n Jimenez Diaz
Madrid, Spain

Hospital Universitario La Paz
Madrid, Spain

Hospital Alvaro Cunqueiro
Pontevedra, Spain

Hospital Cl nico de Valencia
Valencia, Spain

Consorci Hospital General Universitari de Valencia
Valencia, Spain

Hospital Universitari i Politecnic La Fe
Valencia, Spain

Hospital Clinico Universitario de Valladolid
Valladolid, Spain

Royal Devon and Exeter Hospital
Exeter, United Kingdom

Dorset County Hospital
Dorchester, United Kingdom

Gloucestershire Hospitals - NHS Foundation Trust
Gloucester, United Kingdom

Queen Alexandra Hospital
Portsmouth, United Kingdom

Cwm Taf University Health Board
Llantrisant, United Kingdom

University Hospital Coventry
Coventry, United Kingdom

Salisbury NHS Foundation Trust
Salisbury, United Kingdom

Heart of England NHS Foundation Trust
Birmingham, United Kingdom

The Royal Bournemouth Hospital
Bournemouth, United Kingdom

Southampton General Hospital
Southampton, United Kingdom

UZ Antwerpen Gastro-enterologie en hepatologie
Edegem, Belgium

Gastroenterologische Praxis Dr. med. B. Adami
Alzey, Germany

Hippokration General Hospital of Athens
Athens, Greece

University Hospital of Larissa
Mezourlo, Greece

University Hospital of Ioannina
Ioannina, Greece

Universit degli Studi "G. d'Annunzio" Chieti - Pescara
Chieti, Italy

Ospedale Sandro Pertini
Roma, Italy

A.O.U. "S. Maria della Misericordia di Udine"
Udine, Italy

Hospital Universitario de Gran Canaria DR NEGRIN
Las Palmas De Gran Canari, Spain

Hospital Universitario Infanta Sofia
San Sebastian De Los Reye, Spain

CHU Lyon Sud
Pierre-Bénite, France

Onkologische Schwertpunktpraxis
Lörrach, Germany