Clinical trial NCT02539368: Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
Official title: POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn's Disease
Keywords: CT-P13
Inflectra
Remicade
Infliximab
Observational
Follow-up
Safety
Effectiveness
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2015-09-03
Enrollment: 2565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed description: The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.
2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
3. Prior history of failure to respond to Remicade or CT-P13.

Primary outcomes:
measure: Disease Characteristics of Participants: Disease Duration
timeFrame: Baseline (Day 1)
measure: Number of Participants Who Switched Treatment
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
measure: Reasons for Switching Treatment by Participants
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
measure: Total Dose of Infusion Received
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
measure: Number of Participants by Frequency of Infusion Received
timeFrame: Baseline (Day 1)
measure: Number of Participants Who Had Change in Infusion Dose
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
measure: Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
measure: Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
measure: Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)
timeFrame: From baseline to follow-up period (up to a maximum duration of 2 years)
Secondary outcomes:
measure: Number of Participants Remaining in Clinical Remission or Relapse
timeFrame: Months 6, 12, 18 and 24
measure: Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis
timeFrame: At Baseline
measure: Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24
timeFrame: Baseline, Months 6, 12, 18 and 24
measure: Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24
timeFrame: Baseline, Months 6, 12, 18, and 24
measure: Number of Participants With Imaging Test Results
timeFrame: From baseline up to follow-up period (a maximum of 2 years)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg
state: Vlaams Brabant
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Hradec Kralove
country: Czechia
facility: Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o
city: Ostrava - Vitkovice
country: Czechia
facility: Centrum péce o zažívací trakt, Vítkovická nemocnice
city: Prague
country: Czechia
facility: IKEM (Institut Klinické a Experimentální Medicíny)
city: Praha 8 Liben
country: Czechia
facility: Nemocnice Na Bulovce
city: Jyvaskyla
country: Finland
facility: Keski-Suomen keskussairaala
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Besancon
country: France
facility: CHRU de Besancon
city: Caen
country: France
facility: Centre Hospitalier Universitaire
city: Charenton
country: France
facility: Clinique de Bercy
city: Clermont-ferrand
country: France
facility: CHU Clermontferrand
city: Clichy
country: France
facility: Hopital Beaujon
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHRU
city: Lyon
country: France
facility: Hopital Edouard Herriot Pav H
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Hopital Nord
city: Montpellier
country: France
facility: CHU
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Institut Montsouris
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hopital St Louis
city: Pierre-Bénite
country: France
facility: CHU Lyon Sud
city: Pringy
country: France
facility: Hopital Metz Tessy
city: Reims
country: France
facility: Hopital Robert Debre
city: Rouen
country: France
facility: Chu Ch.Nicolle
city: Saint Priez En Jarez
country: France
facility: Service: CHU saint-etienne
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire
city: Toulouse
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Hopital Purpan
city: Vandoeuvre les Nancy
country: France
facility: CHU Nancy
city: Venissieux
country: France
facility: Groupe hospitalier mutualiste les portes du Sud
city: Ludwigshafen am Rhein
country: Germany
facility: St. Marienkrankenhaus
state: Gartenstadt
city: Altenholz
country: Germany
facility: Gemeinschaftspraxis im MEDICUM
city: Alzey
country: Germany
facility: Gastroenterologische Praxis Dr. med. B. Adami
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Berlin
country: Germany
facility: Gastroenterologie Am Bayerischen Platz
city: Burghausen
country: Germany
facility: Kreiskliniken Altotting-Burghausen
city: Frankfurt am Main
country: Germany
facility: Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main
city: Friedrichsthal
country: Germany
facility: Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner
city: Grevenbroich
country: Germany
facility: PraxisZentrum fuer Gastroenterologie
city: Hamburg
country: Germany
facility: Hamburgisches Forschungsinstitut fur chronisch entzuendliche
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne
city: Koethen
country: Germany
facility: Internisten am Markt Dres. Schwerdtfeger & Lehmann
city: Leipzig
country: Germany
facility: Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen
city: Lörrach
country: Germany
facility: Onco Studies an der Onkologie Dreiländereck
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim
city: Mannheim
country: Germany
facility: Magen-Darm Praxis Prof. Dr. Krammer & Kollegen
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Muenchen-Nymphenburg
country: Germany
facility: Praxis Prof.Dr. med. Herbert Kellner
city: Muenster
country: Germany
facility: Medizinisches Versorgungszentrum Portal 10
city: Muenster
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis am Germania-Campus
city: Regensburg
country: Germany
facility: Praxiszentrum Alte Maelzerei
city: Remscheid
country: Germany
facility: Magen-Darm-Zentrum Remscheid
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saarbrücken MVZ GmbH
city: Schweinfurt
country: Germany
facility: Ambulanzzentrum-Schweinfurt
city: Stuttgart
country: Germany
facility: Gastroenterologische Schwerpunktpraxis Stuttgart
city: Rio, Patra
country: Greece
facility: University Hospital of Patras
state: Achaia
city: Athens
country: Greece
facility: Hippokration General Hospital of Athens
state: Attiki
city: Heraklion
country: Greece
facility: Venizeleio Hospital of Heraklion
state: Crete
city: Athens
country: Greece
facility: Evangelismos Hospital
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Ippokrateio
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: MH Egeszsegugyi Kozpont - Honvedkorhaz
city: Szeged
country: Hungary
facility: Szte szent-gyorgyi albert klinikai kozpont
city: San Cataldo (Caltanisetta)
country: Italy
facility: Presidio Ospedaliero "M. Raimondi"
state: Caltanisetta
city: Empoli
country: Italy
facility: ASL 11 Empoli - Ospedale San Giuseppe
state: FI
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
state: FI
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S. Policlinico San Donato
state: Milano
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: PR
city: Negrar
country: Italy
facility: Ospedale "Sacro Cuore - Don Calabria"
state: Verona
city: Brescia
country: Italy
facility: Fondazione Poliambulanza - Istituto Ospedaliero
city: Catania
country: Italy
facility: Azienda Ospedaliera per l'Emergenza Cannizzaro
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"
city: Chieti
country: Italy
facility: Università degli Studi "G. d'Annunzio" Chieti - Pescara
city: Fermo
country: Italy
facility: ASUR Area Vasta n. 4 - Ospedale A. Murri
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: Università degli Studi di Genova
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale di Macerata
city: Messina
country: Italy
facility: A.O.U. Policlinico "G.Martino"
city: Modena
country: Italy
facility: Azienda Ospedaliera - Universitaria di Modena Policlinico
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Palermo
country: Italy
facility: Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello
city: Pisa
country: Italy
facility: AOUP - Ospedale di Cisanello
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria di PISA
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Rome
country: Italy
facility: Ospedale San Camillo
city: Udine
country: Italy
facility: A.O.U. "S. Maria della Misericordia di Udine"
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Gelderland
country: Netherlands
facility: Rijnstate
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca E.P.E
state: Lisbon
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar entre Douro e Vouga E.P.E.
state: Porto
city: Barreiro
country: Portugal
facility: Centro Hospitalar Barreiro Montijo, E.P.E
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria
city: Banska Bystrica
country: Slovakia
facility: FNsP F. D. Roosevelta Banska Bystrica
city: Bratislava
country: Slovakia
facility: V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: A Coruna
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: A Coruna
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
city: Usansolo
country: Spain
facility: Hospital de Galdakao
state: Bizkaia
city: Las Palmas De Gran Canari
country: Spain
facility: Hospital Universitario de Gran Canaria DR NEGRIN
state: Canarias
city: Palma. Mallorca
country: Spain
facility: Hospital Son Espases
state: Illes Balears
city: Alcorcon
country: Spain
facility: Hospital de Alcorcon
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: San Sebastian De Los Reye
country: Spain
facility: Hospital Universitario Infanta Sofia
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Hospital Alvaro Cunqueiro
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Consorci Hospital General Universitari de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Exeter
country: United Kingdom
facility: Royal Gwent Hospital
state: Devon
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
state: Dorset
city: Gloucester
country: United Kingdom
facility: Gloucestershire Hospitals - NHS Foundation Trust
state: Gloucestershire
city: Llantrisant
country: United Kingdom
facility: Cwm Taf University Health Board
state: Wales
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: WEST Midlands
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust
state: Wiltshire
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Hampshire
country: United Kingdom
facility: Queen Alexandra Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: