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)

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: CT-P13; Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 2565

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven campus Gasthuisberg
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Hradec Kralove, Czechia, 500 12
    • Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o
  • Ostrava - Vitkovice, Czechia, 703 84
    • Centrum péce o zažívací trakt, Vítkovická nemocnice
  • Prague, Czechia, 140 21
    • IKEM (Institut Klinické a Experimentální Medicíny)
  • Praha 8 Liben, Czechia, 180 81
    • Nemocnice Na Bulovce
• Finland
  • Jyvaskyla, Finland, FI-40620
    • Keski-Suomen Keskussairaala
  • Oulu, Finland, 90220
    • Oulu University Hospital
  • Turku, Finland, 20521
    • Turku University Hospital
• France
  • Amiens, France, 80054
    • CHU Amiens
  • Angers, France, 49933
    • CHU Angers
  • Besancon, France, 25030
    • CHRU de Besançon
  • Caen, France, 14033
    • Centre Hospitalier Universitaire
  • Charenton, France, 94220
    • Clinique de Bercy
  • Clermont-ferrand, France, 63003
    • CHU Clermontferrand
  • Clichy, France, 92110
    • Hopital Beaujon
  • Colombes, France, 92700
    • Hopital Louis Mourier
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Lille, France, 59000
    • CHRU
  • Lyon, France, 69003
    • Hopital Edouard Herriot Pav H
  • Marseille, France, 13015
    • Hôpital Nord
  • Marseille, France, 13003
    • Hôpital Européen
  • Montpellier, France, 34295
    • CHU
  • Nimes, France, 30029/Cedex 9
    • CHU Nîmes
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75475
    • Hopital St Louis
  • Paris, France, 75012
    • Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie
  • Paris, France, 75014
    • Institut Montsouris
  • Pierre-Bénite, France, 69495
    • CHU Lyon Sud
  • Pringy, France, 74374
    • Hopital Metz Tessy
  • Reims, France, 51000
    • Hopital Robert Debre
  • Rouen, France, 76031
    • Chu Ch.Nicolle
  • Saint Priez En Jarez, France, 42270
    • Service: CHU saint-etienne
  • Strasbourg, France, 67098
    • Centre Hospitalier Universitaire
  • Toulouse, France, 31059
    • Hopital Purpan
  • Toulouse, France, 31059
    • CHU Rangueil
  • Vandoeuvre les Nancy, France, 54511
    • CHU Nancy
  • Venissieux, France, 69694
    • Groupe Hospitalier Mutualiste Les Portes du Sud
• Germany
  • Altenholz, Germany, 24161
    • Gemeinschaftspraxis im MEDICUM
  • Alzey, Germany, 55232
    • Gastroenterologische Praxis Dr. med. B. Adami
  • Aschaffenburg, Germany, 63739
    • Studienzentrum Aschaffenburg
  • Berlin, Germany, 10825
    • Gastroenterologie am Bayerischen Platz
  • Burghausen, Germany, 84489
    • Kreiskliniken Altötting-Burghausen
  • Frankfurt am Main, Germany, 60594
    • Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main
  • Friedrichsthal, Germany, 66299
    • Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner
  • Grevenbroich, Germany, 41515
    • PraxisZentrum fuer Gastroenterologie
  • Hamburg, Germany, 20148
    • Hamburgisches Forschungsinstitut fur chronisch entzuendliche
  • Herne, Germany, 44623
    • Gastroenterologische Gemeinschaftspraxis Herne
  • Koethen, Germany, 06366
    • Internisten am Markt Dres. Schwerdtfeger & Lehmann
  • Leipzig, Germany, 04229
    • Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen
  • Lörrach, Germany, 79539
    • Onco Studies an der Onkologie Dreiländereck
  • Mannheim, Germany, 68135
    • Universitaetsmedizin Mannheim
  • Mannheim, Germany, 68165
    • Magen-Darm Praxis Prof. Dr. Krammer & Kollegen
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden
  • Muenchen-Nymphenburg, Germany, 80639
    • Praxis Prof.Dr. med. Herbert Kellner
  • Muenster, Germany, 48155
    • Medizinisches Versorgungszentrum Portal 10
  • Muenster, Germany, 48159
    • Gastroenterologische Gemeinschaftspraxis am Germania-Campus
  • Regensburg, Germany, 93053
    • Praxiszentrum Alte Maelzerei
  • Remscheid, Germany, 42859
    • Magen-Darm-Zentrum Remscheid
  • Saarbrücken, Germany, 66111
    • Zentrum für Gastroenterologie Saarbrücken MVZ GmbH
  • Schweinfurt, Germany, 97421
    • Ambulanzzentrum-Schweinfurt
  • Stuttgart, Germany, 70178
    • Gastroenterologische Schwerpunktpraxis Stuttgart
  • Gartenstadt
    • Ludwigshafen am Rhein, Gartenstadt, Germany, 67076
      • St. Marienkrankenhaus
• Greece
  • Athens, Greece, 10676
    • Evangelismos Hospital
  • Ioannina, Greece, 455 00
    • University Hospital of Ioannina
  • Larissa, Greece, 41110
    • University Hospital of Larissa
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki Ippokrateio
  • Achaia
    • Rio, Patra, Achaia, Greece, 265 04
      • University Hospital of Patras
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Hippokration General Hospital of Athens
  • Crete
    • Heraklion, Crete, Greece, 71409
      • Venizeleio Hospital of Heraklion
• Hungary
  • Budapest, Hungary, H-1088
    • Semmelweis University
  • Budapest, Hungary, H-1134
    • MH Egeszsegugyi Kozpont - Honvedkorhaz
  • Szeged, Hungary, H-6725
    • Szte szent-gyorgyi albert klinikai kozpont
• Italy
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza - Istituto Ospedaliero
  • Catania, Italy, 95100
    • Azienda Ospedaliera per l'emergenza Cannizzaro
  • Catania, Italy, 95123
    • Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"
  • Chieti, Italy, 66100
    • Università degli Studi "G. d'Annunzio" Chieti - Pescara
  • Fermo, Italy, 63900
    • ASUR Area Vasta n. 4 - Ospedale A. Murri
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Genova, Italy, 16132
    • Universita degli Studi di Genova
  • Macerata, Italy, 62100
    • Ospedale Generale Provinciale di Macerata
  • Messina, Italy, 98125
    • A.O.U. Policlinico "G.Martino"
  • Modena, Italy, 41124
    • Azienda Ospedaliera - Universitaria di Modena Policlinico
  • Palermo, Italy, 90127
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Palermo, Italy, 90146
    • Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello
  • Pisa, Italy, 56124
    • AOUP - Ospedale di Cisanello
  • Pisa, Italy, 56124
    • Azienda Ospedaliera Universitaria di Pisa
  • Roma, Italy, 00157
    • Ospedale Sandro Pertini
  • Rome, Italy, 00152
    • Ospedale San Camillo
  • Udine, Italy, 33100
    • A.O.U. "S. Maria della Misericordia di Udine"
  • Caltanisetta
    • San Cataldo (Caltanisetta), Caltanisetta, Italy, 93100
      • Presidio Ospedaliero "M. Raimondi"
  • FI
    • Empoli, FI, Italy, 50053
      • ASL 11 Empoli - Ospedale San Giuseppe
    • Firenze, FI, Italy, 50134
      • Azienda Ospedaliero Universitaria Careggi
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • I.R.C.C.S. Policlinico San Donato
  • PR
    • Parma, PR, Italy, 43126
      • Azienda Ospedaliero-Universitaria di Parma
  • Verona
    • Negrar, Verona, Italy, 27024
      • Ospedale "Sacro Cuore - Don Calabria"
• Netherlands
  • Ede, Netherlands, 6716 RP
    • Ziekenhuis Gelderse Vallei
  • Eindhoven, Netherlands, 5623
    • Catharina Ziekenhuis
  • Gelderland, Netherlands, 6815 AD
    • Rijnstate
• Portugal
  • Barreiro, Portugal, 2830-003
    • Centro Hospitalar Barreiro Montijo, E.P.E
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria
  • Lisbon
    • Amadora, Lisbon, Portugal, 2720-276
      • Hospital Prof. Doutor Fernando Fonseca E.P.E
  • Porto
    • Santa Maria da Feira, Porto, Portugal, 4520-211
      • Centro Hospitalar entre Douro e Vouga E.P.E.
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • FNsP F. D. Roosevelta Banska Bystrica
  • Bratislava, Slovakia, 826 06
    • V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia
• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañon
  • Madrid, Spain, 28040
    • Hospital Fundación Jimenez Díaz
  • Pontevedra, Spain, 36312
    • Hospital Alvaro Cunqueiro
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Valencia, Spain, 46014
    • Consorci Hospital General Universitari de València
  • Valladolid, Spain, 47005
    • Hospital Clínico Universitario de Valladolid
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Hospital Arquitecto Marcide
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clinico Universitario de Santiago
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
    • Girona, Barcelona, Spain, 17007
      • Hospital Universitari de Girona Dr. Josep Trueta
    • Sabadell, Barcelona, Spain, 08208
      • Hospital de Sabadell
  • Bizkaia
    • Usansolo, Bizkaia, Spain, 48960
      • Hospital de Galdakao
  • Canarias
    • Las Palmas De Gran Canari, Canarias, Spain, 35010
      • Hospital Universitario de Gran Canaria Dr Negrin
  • Illes Balears
    • Palma. Mallorca, Illes Balears, Spain, 07120
      • Hospital Son Espases
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital de Alcorcón
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
    • San Sebastian De Los Reye, Madrid, Spain, 28702
      • Hospital Universitario Infanta Sofía
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Heart of England NHS Foundation Trust
  • Bournemouth, United Kingdom, BH7 7DW
    • The Royal Bournemouth Hospital
  • Hampshire, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Gwent Hospital
  • Dorset
    • Dorchester, Dorset, United Kingdom, DT1 2JY
      • Dorset County Hospital
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Gloucestershire Hospitals - NHS Foundation Trust
  • WEST Midlands
    • Coventry, WEST Midlands, United Kingdom, CV2 2DX
      • University Hospital Coventry
  • Wales
    • Llantrisant, Wales, United Kingdom, CF72 8XR
      • Cwm Taf University Health Board
  • Wiltshire
    • Salisbury, Wiltshire, United Kingdom, SP2 8BJ
      • Salisbury NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CT-P13; biosimilar infliximab	Drug: CT-P13; biosimilar infliximab; Other Names: Remsima; Inflectra
Remicade; infliximab	Drug: Remicade; infliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Remaining in Clinical Remission or Relapse	Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first.	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	HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than [<] 5), mild disease (MD) (score equal to [=] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than [>] 16).	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	HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score < 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score >16).	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	Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6).	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	Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6).	Baseline, Months 6, 12, 18 and 24
Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis	The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing.	At Baseline
Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location	The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted.	Baseline, Months 6, 12, 18 and 24
Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity	The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.	Baseline, Months 6, 12, 18 and 24
Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent	The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC.	Baseline, Months 6, 12, 18 and 24
Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity	The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day [with or without blood], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily).	Baseline, Months 6, 12, 18 and 24
Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index	The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity.	Baseline, Months 6, 12, 18 and 24
Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24	C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.	Baseline, Months 6, 12, 18 and 24
Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24	Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin.	Baseline, Months 6, 12, 18, and 24
Number of Participants With Imaging Test Results	Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported.	From baseline up to follow-up period (a maximum of 2 years)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2015
• Primary Completion (ACTUAL): October 31, 2018
• Study Completion (ACTUAL): October 31, 2018

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (ESTIMATE): September 3, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Observational; Follow-up; Effectiveness; Infliximab; Remicade; Inflectra; CT-P13
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: ZOB INF 1402; C1231001 (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No