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CONNECT-IBD: Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02539368
Collaborator
Hospira, now a wholly owned subsidiary of Pfizer (Industry)
2,565
Enrollment
140
Locations
42.3
Actual Duration (Months)
18.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
2565 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)
Actual Study Start Date :
Apr 22, 2015
Actual Primary Completion Date :
Oct 31, 2018
Actual Study Completion Date :
Oct 31, 2018

Arms and Interventions

Arm Intervention/Treatment
CT-P13

biosimilar infliximab

Drug: CT-P13
biosimilar infliximab
Other Names:
  • Inflectra
  • Remsima

    		•
    Remicade

    infliximab

    Drug: Remicade
    infliximab

    Outcome Measures

    Primary Outcome Measures

    1. Disease Characteristics of Participants: Disease Duration [Baseline (Day 1)]

      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).

    2. Number of Participants Who Switched Treatment [From baseline to follow-up period (up to a maximum duration of 2 years)]

      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.

    3. Reasons for Switching Treatment by Participants [From baseline to follow-up period (up to a maximum duration of 2 years)]

    4. Total Dose of Infusion Received [From baseline to follow-up period (up to a maximum duration of 2 years)]

      Total dose of infusion received by the participants was calculated.

    5. Number of Participants by Frequency of Infusion Received [Baseline (Day 1)]

      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.

    6. Number of Participants Who Had Change in Infusion Dose [From baseline to follow-up period (up to a maximum duration of 2 years)]

      Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.

    7. Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change [From baseline to follow-up period (up to a maximum duration of 2 years)]

      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.

    8. 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)]

    9. Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) [From baseline to follow-up period (up to a maximum duration of 2 years)]

      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.

    Secondary Outcome Measures

    1. Number of Participants Remaining in Clinical Remission or Relapse [Months 6, 12, 18 and 24]

      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.

    2. 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]

      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).

    3. 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]

      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).

    4. 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]

      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).

    5. 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]

      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).

    6. Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis [At Baseline]

      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.

    7. Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location [Baseline, Months 6, 12, 18 and 24]

      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.

    8. Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity [Baseline, Months 6, 12, 18 and 24]

      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.

    9. Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent [Baseline, Months 6, 12, 18 and 24]

      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.

    10. Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity [Baseline, Months 6, 12, 18 and 24]

      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).

    11. Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index [Baseline, Months 6, 12, 18 and 24]

      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.

    12. Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24 [Baseline, 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.

    13. Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24 [Baseline, 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.

    14. Number of Participants With Imaging Test Results [From baseline up to follow-up period (a maximum of 2 years)]

      Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Pfizer
    • Hospira, now a wholly owned subsidiary of Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02539368
    Other Study ID Numbers:
    • ZOB INF 1402
    • C1231001
    First Posted:
    Sep 3, 2015
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Pfizer
    CT-P13
    Inflectra
    Remicade
    Infliximab
    Observational
    Follow-up
    Safety
    Effectiveness
    Additional relevant MeSH terms:
    Crohn Disease
    Intestinal Diseases
    Inflammatory Bowel Diseases
    Infliximab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 2565 participants were enrolled in the study, out of which 22 participants were not eligible to receive treatment for any of the treatment groups. Hence, only those participants who received treatment during the study observation period were included in the participants flow section.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Period Title: Overall Study
    STARTED 1522 494 358 67 102
    COMPLETED 1117 393 291 60 88
    NOT COMPLETED 405 101 67 7 14

    Baseline Characteristics

    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers Total
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD. Total of all reporting groups
    Overall Participants 1522 494 358 67 102 2543
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    39.8
    (14.65)
    38.8
    (12.74)
    40.9
    (14.14)
    41.1
    (13.96)
    38.4
    (13.23)
    39.8
    (13.74)
    Sex: Female, Male (Count of Participants)
    Female
    750
    49.3%
    233
    47.2%
    158
    44.1%
    29
    43.3%
    48
    47.1%
    1218
    47.9%
    Male
    772
    50.7%
    261
    52.8%
    200
    55.9%
    38
    56.7%
    54
    52.9%
    1325
    52.1%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    4
    0.3%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    5
    0.2%
    Asian
    5
    0.3%
    3
    0.6%
    5
    1.4%
    0
    0%
    0
    0%
    13
    0.5%
    Native Hawaiian or Other Pacific Islander
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0%
    Black or African American
    7
    0.5%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    8
    0.3%
    White
    1080
    71%
    391
    79.1%
    275
    76.8%
    55
    82.1%
    83
    81.4%
    1884
    74.1%
    Other
    267
    17.5%
    60
    12.1%
    49
    13.7%
    11
    16.4%
    14
    13.7%
    401
    15.8%
    Unknown or Not Reported
    158
    10.4%
    39
    7.9%
    28
    7.8%
    1
    1.5%
    5
    4.9%
    231
    9.1%
    Participants With Medical History of Smoking (Count of Participants)
    Count of Participants [Participants]
    320
    21%
    94
    19%
    70
    19.6%
    12
    17.9%
    17
    16.7%
    513
    20.2%
    Participants With a History of Cancer (Count of Participants)
    Count of Participants [Participants]
    41
    2.7%
    10
    2%
    6
    1.7%
    1
    1.5%
    4
    3.9%
    62
    2.4%
    Participants With Stoma Status (Count of Participants)
    Count of Participants [Participants]
    33
    2.2%
    13
    2.6%
    14
    3.9%
    3
    4.5%
    2
    2%
    65
    2.6%
    Participants With a History Surgery (Count of Participants)
    Count of Participants [Participants]
    395
    26%
    165
    33.4%
    116
    32.4%
    23
    34.3%
    32
    31.4%
    731
    28.7%
    Participants With a History of Fistula Disease (Count of Participants)
    Count of Participants [Participants]
    304
    20%
    124
    25.1%
    86
    24%
    19
    28.4%
    28
    27.5%
    561
    22.1%

    Outcome Measures

    1. Primary Outcome
    Title Disease Characteristics of Participants: Disease Duration
    Description 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).
    Time Frame Baseline (Day 1)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1519 494 358 67 102
    Median (Full Range) [months]
    63.0
    112.5
    120.0
    86.0
    101.0
    2. Primary Outcome
    Title Number of Participants Who Switched Treatment
    Description 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.
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.
    Arm/Group Title Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 358 67 102
    Crohn's Disease
    237
    15.6%
    47
    9.5%
    72
    20.1%
    Ulcerative Colitis
    121
    8%
    20
    4%
    30
    8.4%
    3. Primary Outcome
    Title Reasons for Switching Treatment by Participants
    Description
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Reasons for switch were not captured in electronic data capture. Hence, due to change in planned analysis, data was not collected and analyzed.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 0 0 0 0 0
    4. Primary Outcome
    Title Total Dose of Infusion Received
    Description Total dose of infusion received by the participants was calculated.
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1520 493 358 67 102
    Median (Full Range) [milligram]
    NA
    NA
    NA
    NA
    NA
    5. Primary Outcome
    Title Number of Participants by Frequency of Infusion Received
    Description 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.
    Time Frame Baseline (Day 1)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1283 433 317 60 85
    Once a week
    5
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Once every 2 weeks
    140
    9.2%
    5
    1%
    11
    3.1%
    3
    4.5%
    3
    2.9%
    Once every 3 weeks
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    Once every 4 weeks
    109
    7.2%
    47
    9.5%
    32
    8.9%
    9
    13.4%
    7
    6.9%
    Once every 5 weeks
    7
    0.5%
    8
    1.6%
    5
    1.4%
    0
    0%
    4
    3.9%
    Once every 6 weeks
    84
    5.5%
    67
    13.6%
    43
    12%
    3
    4.5%
    15
    14.7%
    Once every 7 weeks
    9
    0.6%
    27
    5.5%
    14
    3.9%
    2
    3%
    4
    3.9%
    Once every 8 weeks
    804
    52.8%
    247
    50%
    198
    55.3%
    42
    62.7%
    47
    46.1%
    Other
    124
    8.1%
    32
    6.5%
    14
    3.9%
    1
    1.5%
    4
    3.9%
    6. Primary Outcome
    Title Number of Participants Who Had Change in Infusion Dose
    Description Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1522 494 358 67 102
    Count of Participants [Participants]
    479
    31.5%
    110
    22.3%
    89
    24.9%
    28
    41.8%
    31
    30.4%
    7. Primary Outcome
    Title Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change
    Description 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.
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 479 110 89 28 31
    Principal Investigator's Decision
    213
    14%
    61
    12.3%
    31
    8.7%
    26
    38.8%
    16
    15.7%
    Participant's Decision
    5
    0.3%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Loss of response
    142
    9.3%
    27
    5.5%
    17
    4.7%
    3
    4.5%
    12
    11.8%
    Lack of compliance
    3
    0.2%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Hypersensitivity
    4
    0.3%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Occurrence of Adverse Event (including AESI/SAE)
    23
    1.5%
    3
    0.6%
    3
    0.8%
    0
    0%
    2
    2%
    Positive for antibodies
    5
    0.3%
    2
    0.4%
    2
    0.6%
    0
    0%
    0
    0%
    Other
    142
    9.3%
    26
    5.3%
    42
    11.7%
    2
    3%
    9
    8.8%
    8. Primary Outcome
    Title Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)
    Description
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1522 494 358 67 102
    Count of Participants [Participants]
    1025
    67.3%
    262
    53%
    187
    52.2%
    39
    58.2%
    67
    65.7%
    9. Primary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)
    Description 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.
    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1522 494 358 67 102
    TEAEs
    621
    40.8%
    133
    26.9%
    130
    36.3%
    15
    22.4%
    30
    29.4%
    SAEs
    256
    16.8%
    43
    8.7%
    57
    15.9%
    10
    14.9%
    15
    14.7%
    TEAEs of Special Interest
    189
    12.4%
    49
    9.9%
    37
    10.3%
    8
    11.9%
    11
    10.8%
    10. Secondary Outcome
    Title Number of Participants Remaining in Clinical Remission or Relapse
    Description 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.
    Time Frame Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS)=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to assessment of CD or UC).Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1516 492 358 67 102
    Remission
    870
    57.2%
    312
    63.2%
    261
    72.9%
    51
    76.1%
    70
    68.6%
    Relapse
    166
    10.9%
    23
    4.7%
    19
    5.3%
    3
    4.5%
    4
    3.9%
    Remission
    802
    52.7%
    288
    58.3%
    224
    62.6%
    45
    67.2%
    58
    56.9%
    Relapse
    112
    7.4%
    18
    3.6%
    16
    4.5%
    2
    3%
    6
    5.9%
    Remission
    633
    41.6%
    257
    52%
    192
    53.6%
    31
    46.3%
    61
    59.8%
    Relapse
    70
    4.6%
    11
    2.2%
    11
    3.1%
    1
    1.5%
    5
    4.9%
    Remission
    386
    25.4%
    184
    37.2%
    148
    41.3%
    23
    34.3%
    39
    38.2%
    Relapse
    38
    2.5%
    7
    1.4%
    9
    2.5%
    1
    1.5%
    4
    3.9%
    11. Secondary Outcome
    Title Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission
    Description 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).
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 969 348 237 47 72
    At Baseline
    606
    39.8%
    246
    49.8%
    150
    41.9%
    29
    43.3%
    49
    48%
    Baseline-CR; Month 6-CR
    485
    31.9%
    211
    42.7%
    125
    34.9%
    24
    35.8%
    43
    42.2%
    Baseline-CR; Month 6-MD
    42
    2.8%
    11
    2.2%
    11
    3.1%
    2
    3%
    4
    3.9%
    Baseline-CR; Month 6-Mod D
    23
    1.5%
    8
    1.6%
    2
    0.6%
    1
    1.5%
    0
    0%
    Baseline-CR; Month 6-SD
    1
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-CR; Month 6-Missing
    55
    3.6%
    15
    3%
    12
    3.4%
    2
    3%
    2
    2%
    Baseline-CR; Month 12-CR
    429
    28.2%
    182
    36.8%
    109
    30.4%
    22
    32.8%
    42
    41.2%
    Baseline-CR; Month 12-MD
    36
    2.4%
    14
    2.8%
    8
    2.2%
    3
    4.5%
    1
    1%
    Baseline-CR; Month 12-Mod D
    20
    1.3%
    4
    0.8%
    5
    1.4%
    1
    1.5%
    0
    0%
    Baseline-CR; Month 12-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-CR; Month 12-Missing
    121
    8%
    46
    9.3%
    28
    7.8%
    3
    4.5%
    6
    5.9%
    Baseline-CR; Month 18-CR
    326
    21.4%
    143
    28.9%
    96
    26.8%
    17
    25.4%
    37
    36.3%
    Baseline-CR; Month 18-MD
    25
    1.6%
    11
    2.2%
    4
    1.1%
    0
    0%
    1
    1%
    Baseline-CR; Month 18-Mod D
    8
    0.5%
    4
    0.8%
    2
    0.6%
    0
    0%
    1
    1%
    Baseline-CR; Month 18-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-CR; Month 18-Missing
    247
    16.2%
    88
    17.8%
    48
    13.4%
    12
    17.9%
    10
    9.8%
    Baseline-CR; Month 24-CR
    194
    12.7%
    98
    19.8%
    68
    19%
    11
    16.4%
    28
    27.5%
    Baseline-CR; Month 24-MD
    16
    1.1%
    7
    1.4%
    3
    0.8%
    1
    1.5%
    2
    2%
    Baseline-CR; Month 24-Mod D
    5
    0.3%
    1
    0.2%
    3
    0.8%
    0
    0%
    0
    0%
    Baseline-CR; Month 24-SD
    0
    0%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-CR; Month 24-Missing
    391
    25.7%
    140
    28.3%
    75
    20.9%
    17
    25.4%
    19
    18.6%
    12. Secondary Outcome
    Title Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity
    Description 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).
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 969 348 237 47 72
    At Baseline: MD
    137
    9%
    45
    9.1%
    24
    6.7%
    10
    14.9%
    7
    6.9%
    At Baseline: Mod D
    91
    6%
    22
    4.5%
    15
    4.2%
    4
    6%
    3
    2.9%
    At Baseline: SD
    6
    0.4%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 6-CR
    82
    5.4%
    21
    4.3%
    9
    2.5%
    5
    7.5%
    3
    2.9%
    Baseline-MD; Month 6-MD
    30
    2%
    13
    2.6%
    11
    3.1%
    4
    6%
    1
    1%
    Baseline-MD; Month 6-Mod D
    12
    0.8%
    8
    1.6%
    3
    0.8%
    0
    0%
    2
    2%
    Baseline-MD; Month 6-SD
    0
    0%
    0
    0%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-MD; Month 6-Missing
    13
    0.9%
    3
    0.6%
    0
    0%
    1
    1.5%
    0
    0%
    Baseline-Mod D; Month 6-CR
    39
    2.6%
    4
    0.8%
    6
    1.7%
    3
    4.5%
    2
    2%
    Baseline-Mod D; Month 6-MD
    19
    1.2%
    6
    1.2%
    2
    0.6%
    1
    1.5%
    0
    0%
    Baseline-Mod D; Month 6-Mod D
    25
    1.6%
    8
    1.6%
    6
    1.7%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 6-SD
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 6-Missing
    7
    0.5%
    4
    0.8%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-SD; Month 6-CR
    1
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-MD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-Mod D
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-SD
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-Missing
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 12-CR
    81
    5.3%
    24
    4.9%
    14
    3.9%
    6
    9%
    4
    3.9%
    Baseline-MD; Month 12-MD
    16
    1.1%
    6
    1.2%
    3
    0.8%
    2
    3%
    1
    1%
    Baseline-MD; Month 12-Mod D
    7
    0.5%
    6
    1.2%
    3
    0.8%
    0
    0%
    1
    1%
    Baseline-MD; Month 12-SD
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    Baseline-MD; Month 12-Missing
    32
    2.1%
    9
    1.8%
    4
    1.1%
    2
    3%
    0
    0%
    Baseline-Mod D; Month 12-CR
    39
    2.6%
    6
    1.2%
    4
    1.1%
    3
    4.5%
    3
    2.9%
    Baseline-Mod D; Month 12-MD
    15
    1%
    9
    1.8%
    0
    0%
    1
    1.5%
    0
    0%
    Baseline-Mod D; Month 12-Mod D
    16
    1.1%
    2
    0.4%
    6
    1.7%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 12-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 12-Missing
    21
    1.4%
    5
    1%
    5
    1.4%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-CR
    1
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-MD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-Mod D
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-SD
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-Missing
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 18-CR
    60
    3.9%
    24
    4.9%
    12
    3.4%
    2
    3%
    2
    2%
    Baseline-MD; Month 18-MD
    10
    0.7%
    6
    1.2%
    1
    0.3%
    4
    6%
    3
    2.9%
    Baseline-MD; Month 18-Mod D
    4
    0.3%
    2
    0.4%
    1
    0.3%
    0
    0%
    2
    2%
    Baseline-MD; Month 18-SD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 18-Missing
    61
    4%
    13
    2.6%
    10
    2.8%
    4
    6%
    0
    0%
    Baseline-Mod D; Month 18-CR
    30
    2%
    4
    0.8%
    2
    0.6%
    3
    4.5%
    2
    2%
    Baseline-Mod D; Month 18-MD
    13
    0.9%
    7
    1.4%
    2
    0.6%
    1
    1.5%
    1
    1%
    Baseline-Mod D; Month 18-Mod D
    14
    0.9%
    3
    0.6%
    3
    0.8%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 18-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 18-Missing
    34
    2.2%
    8
    1.6%
    8
    2.2%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-CR
    1
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-MD
    2
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-Mod D
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-Missing
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 24-CR
    34
    2.2%
    13
    2.6%
    8
    2.2%
    5
    7.5%
    2
    2%
    Baseline-MD; Month 24-MD
    15
    1%
    6
    1.2%
    2
    0.6%
    1
    1.5%
    2
    2%
    Baseline-MD; Month 24-Mod D
    2
    0.1%
    1
    0.2%
    1
    0.3%
    0
    0%
    2
    2%
    Baseline-MD; Month 24-SD
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 24-Missing
    85
    5.6%
    25
    5.1%
    13
    3.6%
    4
    6%
    1
    1%
    Baseline-Mod D; Month 24-CR
    23
    1.5%
    3
    0.6%
    4
    1.1%
    3
    4.5%
    1
    1%
    Baseline-Mod D; Month 24-MD
    5
    0.3%
    2
    0.4%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-Mod D; Month 24-Mod D
    10
    0.7%
    9
    1.8%
    3
    0.8%
    1
    1.5%
    0
    0%
    Baseline-Mod D; Month 24-SD
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 24-Missing
    52
    3.4%
    8
    1.6%
    7
    2%
    0
    0%
    1
    1%
    Baseline-SD; Month 24-CR
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-MD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-Mod D
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-SD
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-Missing
    4
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    13. Secondary Outcome
    Title Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission
    Description 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).
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 547 144 121 20 30
    At Baseline
    169
    11.1%
    83
    16.8%
    55
    15.4%
    9
    13.4%
    13
    12.7%
    Baseline-CR; Month 6-CR
    117
    7.7%
    65
    13.2%
    40
    11.2%
    7
    10.4%
    9
    8.8%
    Baseline-CR; Month 6-MD
    27
    1.8%
    9
    1.8%
    7
    2%
    2
    3%
    2
    2%
    Baseline-CR; Month 6-Mod D
    7
    0.5%
    0
    0%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-CR; Month 6-SD
    1
    0.1%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-CR; Month 6-Missing
    17
    1.1%
    9
    1.8%
    6
    1.7%
    0
    0%
    1
    1%
    Baseline-CR; Month 12-CR
    107
    7%
    65
    13.2%
    30
    8.4%
    8
    11.9%
    8
    7.8%
    Baseline-CR; Month 12-MD
    24
    1.6%
    4
    0.8%
    10
    2.8%
    0
    0%
    4
    3.9%
    Baseline-CR; Month 12-Mod D
    5
    0.3%
    0
    0%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-CR; Month 12-SD
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-CR; Month 12-Missing
    32
    2.1%
    14
    2.8%
    14
    3.9%
    1
    1.5%
    0
    0%
    Baseline-CR; Month 18-CR
    88
    5.8%
    55
    11.1%
    25
    7%
    3
    4.5%
    9
    8.8%
    Baseline-CR; Month 18-MD
    13
    0.9%
    8
    1.6%
    4
    1.1%
    0
    0%
    0
    0%
    Baseline-CR; Month 18-Mod D
    6
    0.4%
    0
    0%
    2
    0.6%
    0
    0%
    3
    2.9%
    Baseline-CR; Month 18-SD
    2
    0.1%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-CR; Month 18-Missing
    60
    3.9%
    20
    4%
    23
    6.4%
    6
    9%
    1
    1%
    Baseline-CR; Month 24-CR
    57
    3.7%
    38
    7.7%
    22
    6.1%
    3
    4.5%
    6
    5.9%
    Baseline-CR; Month 24-MD
    7
    0.5%
    5
    1%
    3
    0.8%
    0
    0%
    0
    0%
    Baseline-CR; Month 24-Mod D
    2
    0.1%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-CR; Month 24-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-CR; Month 24-Missing
    103
    6.8%
    39
    7.9%
    29
    8.1%
    6
    9%
    7
    6.9%
    14. Secondary Outcome
    Title Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity
    Description 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).
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 547 144 121 20 30
    At Baseline: MD
    157
    10.3%
    30
    6.1%
    28
    7.8%
    4
    6%
    9
    8.8%
    At Baseline: Mod D
    76
    5%
    13
    2.6%
    9
    2.5%
    3
    4.5%
    4
    3.9%
    At Baseline: SD
    47
    3.1%
    5
    1%
    3
    0.8%
    0
    0%
    1
    1%
    Baseline-MD; Month 6-CR
    71
    4.7%
    12
    2.4%
    19
    5.3%
    3
    4.5%
    3
    2.9%
    Baseline-MD; Month 6-MD
    48
    3.2%
    12
    2.4%
    4
    1.1%
    1
    1.5%
    6
    5.9%
    Baseline-MD; Month 6-Mod D
    18
    1.2%
    2
    0.4%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-MD; Month 6-SD
    7
    0.5%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-MD; Month 6-Missing
    13
    0.9%
    4
    0.8%
    3
    0.8%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 6-CR
    18
    1.2%
    3
    0.6%
    2
    0.6%
    3
    4.5%
    2
    2%
    Baseline-Mod D; Month 6-MD
    22
    1.4%
    8
    1.6%
    5
    1.4%
    0
    0%
    2
    2%
    Baseline-Mod D; Month 6-Mod D
    21
    1.4%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 6-SD
    8
    0.5%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 6-Missing
    7
    0.5%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-CR
    8
    0.5%
    2
    0.4%
    0
    0%
    0
    0%
    1
    1%
    Baseline-SD; Month 6-MD
    19
    1.2%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-Mod D
    6
    0.4%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-SD
    7
    0.5%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-SD; Month 6-Missing
    7
    0.5%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 12-CR
    73
    4.8%
    16
    3.2%
    14
    3.9%
    2
    3%
    2
    2%
    Baseline-MD; Month 12-MD
    38
    2.5%
    6
    1.2%
    7
    2%
    1
    1.5%
    5
    4.9%
    Baseline-MD; Month 12-Mod D
    10
    0.7%
    3
    0.6%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-MD; Month 12-SD
    3
    0.2%
    0
    0%
    1
    0.3%
    1
    1.5%
    0
    0%
    Baseline-MD; Month 12-Missing
    33
    2.2%
    5
    1%
    5
    1.4%
    0
    0%
    1
    1%
    Baseline-Mod D; Month 12-CR
    24
    1.6%
    2
    0.4%
    4
    1.1%
    2
    3%
    1
    1%
    Baseline-Mod D; Month 12-MD
    17
    1.1%
    6
    1.2%
    2
    0.6%
    0
    0%
    2
    2%
    Baseline-Mod D; Month 12-Mod D
    6
    0.4%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 12-SD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 12-Missing
    27
    1.8%
    4
    0.8%
    3
    0.8%
    1
    1.5%
    1
    1%
    Baseline-SD; Month 12-CR
    15
    1%
    2
    0.4%
    0
    0%
    0
    0%
    1
    1%
    Baseline-SD; Month 12-MD
    8
    0.5%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-Mod D
    5
    0.3%
    0
    0%
    2
    0.6%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-SD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 12-Missing
    17
    1.1%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 18-CR
    57
    3.7%
    14
    2.8%
    15
    4.2%
    3
    4.5%
    3
    2.9%
    Baseline-MD; Month 18-MD
    22
    1.4%
    5
    1%
    6
    1.7%
    0
    0%
    2
    2%
    Baseline-MD; Month 18-Mod D
    8
    0.5%
    1
    0.2%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-MD; Month 18-SD
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 18-Missing
    68
    4.5%
    10
    2%
    6
    1.7%
    1
    1.5%
    3
    2.9%
    Baseline-Mod D; Month 18-CR
    23
    1.5%
    4
    0.8%
    2
    0.6%
    1
    1.5%
    1
    1%
    Baseline-Mod D; Month 18-MD
    16
    1.1%
    2
    0.4%
    1
    0.3%
    0
    0%
    2
    2%
    Baseline-Mod D; Month 18-Mod D
    2
    0.1%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 18-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 18-Missing
    35
    2.3%
    6
    1.2%
    5
    1.4%
    2
    3%
    1
    1%
    Baseline-SD; Month 18-CR
    15
    1%
    2
    0.4%
    1
    0.3%
    0
    0%
    1
    1%
    Baseline-SD; Month 18-MD
    5
    0.3%
    1
    0.2%
    2
    0.6%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-Mod D
    3
    0.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 18-Missing
    24
    1.6%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 24-CR
    43
    2.8%
    13
    2.6%
    13
    3.6%
    2
    3%
    5
    4.9%
    Baseline-MD; Month 24-MD
    10
    0.7%
    4
    0.8%
    3
    0.8%
    0
    0%
    1
    1%
    Baseline-MD; Month 24-Mod D
    5
    0.3%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-MD; Month 24-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-MD; Month 24-Missing
    99
    6.5%
    12
    2.4%
    11
    3.1%
    2
    3%
    3
    2.9%
    Baseline-Mod D; Month 24-CR
    15
    1%
    2
    0.4%
    0
    0%
    0
    0%
    2
    2%
    Baseline-Mod D; Month 24-MD
    11
    0.7%
    3
    0.6%
    0
    0%
    0
    0%
    1
    1%
    Baseline-Mod D; Month 24-Mod D
    1
    0.1%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 24-SD
    2
    0.1%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-Mod D; Month 24-Missing
    47
    3.1%
    7
    1.4%
    7
    2%
    3
    4.5%
    1
    1%
    Baseline-SD; Month 24-CR
    8
    0.5%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-MD
    8
    0.5%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-Mod D
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-SD
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Baseline-SD; Month 24-Missing
    30
    2%
    2
    0.4%
    2
    0.6%
    0
    0%
    1
    1%
    15. Secondary Outcome
    Title Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis
    Description 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.
    Time Frame At Baseline

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified rows for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 777 240 164 37 50
    16 years or younger
    61
    4%
    33
    6.7%
    21
    5.9%
    4
    6%
    6
    5.9%
    17-40 years
    553
    36.3%
    174
    35.2%
    115
    32.1%
    25
    37.3%
    39
    38.2%
    Over 40 years
    162
    10.6%
    33
    6.7%
    28
    7.8%
    8
    11.9%
    5
    4.9%
    Missing
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    16. Secondary Outcome
    Title Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location
    Description 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.
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 969 348 237 47 72
    L1 Terminal ileum
    257
    16.9%
    62
    12.6%
    34
    9.5%
    6
    9%
    11
    10.8%
    L2 Colon
    135
    8.9%
    54
    10.9%
    32
    8.9%
    14
    20.9%
    8
    7.8%
    L3 Ileocolon
    329
    21.6%
    107
    21.7%
    80
    22.3%
    16
    23.9%
    28
    27.5%
    L4 Upper GI
    14
    0.9%
    4
    0.8%
    4
    1.1%
    1
    1.5%
    0
    0%
    L1 Terminal ileum, L4 Upper GI
    21
    1.4%
    2
    0.4%
    1
    0.3%
    0
    0%
    1
    1%
    L2 Colon, L4 Upper GI
    6
    0.4%
    2
    0.4%
    1
    0.3%
    0
    0%
    1
    1%
    L3 Ileocolon, L4 Upper GI
    14
    0.9%
    8
    1.6%
    12
    3.4%
    0
    0%
    1
    1%
    Missing
    1
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    L1 Terminal ileum
    202
    13.3%
    49
    9.9%
    26
    7.3%
    7
    10.4%
    9
    8.8%
    L2 Colon
    105
    6.9%
    47
    9.5%
    25
    7%
    12
    17.9%
    11
    10.8%
    L3 Ileocolon
    236
    15.5%
    94
    19%
    65
    18.2%
    13
    19.4%
    22
    21.6%
    L4 Upper GI
    12
    0.8%
    2
    0.4%
    3
    0.8%
    1
    1.5%
    0
    0%
    L1 Terminal ileum, L4 Upper GI
    15
    1%
    2
    0.4%
    1
    0.3%
    0
    0%
    0
    0%
    L2 Colon, L4 Upper GI
    3
    0.2%
    3
    0.6%
    0
    0%
    0
    0%
    0
    0%
    L3 Ileocolon, L4 Upper GI
    11
    0.7%
    5
    1%
    7
    2%
    0
    0%
    2
    2%
    Missing
    5
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    L1 Terminal ileum
    150
    9.9%
    38
    7.7%
    22
    6.1%
    7
    10.4%
    7
    6.9%
    L2 Colon
    84
    5.5%
    40
    8.1%
    20
    5.6%
    14
    20.9%
    10
    9.8%
    L3 Ileocolon
    200
    13.1%
    71
    14.4%
    55
    15.4%
    11
    16.4%
    21
    20.6%
    L4 Upper GI
    10
    0.7%
    3
    0.6%
    2
    0.6%
    1
    1.5%
    1
    1%
    L1 Terminal ileum, L4 Upper GI
    11
    0.7%
    2
    0.4%
    1
    0.3%
    0
    0%
    0
    0%
    L2 Colon, L4 Upper GI
    2
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    L3 Ileocolon, L4 Upper GI
    8
    0.5%
    5
    1%
    4
    1.1%
    0
    0%
    1
    1%
    Missing
    3
    0.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    L1 Terminal ileum
    99
    6.5%
    28
    5.7%
    16
    4.5%
    2
    3%
    8
    7.8%
    L2 Colon
    53
    3.5%
    31
    6.3%
    18
    5%
    10
    14.9%
    9
    8.8%
    L3 Ileocolon
    150
    9.9%
    55
    11.1%
    40
    11.2%
    8
    11.9%
    17
    16.7%
    L4 Upper GI
    8
    0.5%
    5
    1%
    4
    1.1%
    1
    1.5%
    1
    1%
    L1 Terminal ileum, L4 Upper GI
    13
    0.9%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    L2 Colon, L4 Upper GI
    2
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    L3 Ileocolon, L4 Upper GI
    5
    0.3%
    4
    0.8%
    7
    2%
    1
    1.5%
    1
    1%
    Missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    L1 Terminal ileum
    60
    3.9%
    17
    3.4%
    15
    4.2%
    0
    0%
    5
    4.9%
    L2 Colon
    41
    2.7%
    16
    3.2%
    14
    3.9%
    9
    13.4%
    5
    4.9%
    L3 Ileocolon
    74
    4.9%
    33
    6.7%
    22
    6.1%
    9
    13.4%
    14
    13.7%
    L4 Upper GI
    7
    0.5%
    6
    1.2%
    3
    0.8%
    0
    0%
    1
    1%
    L1 Terminal ileum, L4 Upper GI
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    L2 Colon, L4 Upper GI
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    L3 Ileocolon, L4 Upper GI
    5
    0.3%
    2
    0.4%
    3
    0.8%
    0
    0%
    2
    2%
    Missing
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    17. Secondary Outcome
    Title Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity
    Description 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.
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 969 348 237 47 72
    B1 NS, NP
    324
    21.3%
    92
    18.6%
    66
    18.4%
    9
    13.4%
    17
    16.7%
    B2 Stricturing
    165
    10.8%
    40
    8.1%
    43
    12%
    9
    13.4%
    13
    12.7%
    B3 Penetrating
    84
    5.5%
    32
    6.5%
    16
    4.5%
    6
    9%
    6
    5.9%
    p Perianal disease
    34
    2.2%
    5
    1%
    7
    2%
    2
    3%
    3
    2.9%
    B2 Stricturing, B3 Penetrating
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS,NP, p Perianal disease
    77
    5.1%
    33
    6.7%
    16
    4.5%
    5
    7.5%
    5
    4.9%
    B2 Stricturing, p Perianal disease
    32
    2.1%
    8
    1.6%
    4
    1.1%
    1
    1.5%
    1
    1%
    B2 Stricturing, B3 Penetrating, p Perianal disease
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B3 Penetrating, p Perianal disease
    57
    3.7%
    30
    6.1%
    12
    3.4%
    5
    7.5%
    5
    4.9%
    Missing
    3
    0.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS, NP
    242
    15.9%
    68
    13.8%
    46
    12.8%
    10
    14.9%
    14
    13.7%
    B2 Stricturing
    122
    8%
    29
    5.9%
    36
    10.1%
    8
    11.9%
    12
    11.8%
    B3 Penetrating
    64
    4.2%
    32
    6.5%
    14
    3.9%
    5
    7.5%
    5
    4.9%
    p Perianal disease
    27
    1.8%
    5
    1%
    4
    1.1%
    1
    1.5%
    1
    1%
    B2 Stricturing, B3 Penetrating
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS,NP, p Perianal disease
    64
    4.2%
    34
    6.9%
    11
    3.1%
    5
    7.5%
    6
    5.9%
    B2 Stricturing, p Perianal disease
    22
    1.4%
    5
    1%
    3
    0.8%
    1
    1.5%
    0
    0%
    B2 Stricturing, B3 Penetrating, p Perianal disease
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B3 Penetrating, p Perianal disease
    42
    2.8%
    29
    5.9%
    13
    3.6%
    3
    4.5%
    6
    5.9%
    Missing
    5
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS, NP
    191
    12.5%
    56
    11.3%
    40
    11.2%
    10
    14.9%
    17
    16.7%
    B2 Stricturing
    94
    6.2%
    26
    5.3%
    28
    7.8%
    6
    9%
    9
    8.8%
    B3 Penetrating
    48
    3.2%
    26
    5.3%
    12
    3.4%
    5
    7.5%
    2
    2%
    p Perianal disease
    17
    1.1%
    7
    1.4%
    1
    0.3%
    1
    1.5%
    1
    1%
    B2 Stricturing, B3 Penetrating
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS,NP, p Perianal disease
    60
    3.9%
    20
    4%
    9
    2.5%
    6
    9%
    6
    5.9%
    B2 Stricturing, p Perianal disease
    22
    1.4%
    5
    1%
    3
    0.8%
    2
    3%
    0
    0%
    B2 Stricturing, B3 Penetrating, p Perianal disease
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B3 Penetrating, p Perianal disease
    33
    2.2%
    20
    4%
    11
    3.1%
    3
    4.5%
    5
    4.9%
    Missing
    3
    0.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS, NP
    135
    8.9%
    44
    8.9%
    26
    7.3%
    4
    6%
    13
    12.7%
    B2 Stricturing
    77
    5.1%
    24
    4.9%
    26
    7.3%
    4
    6%
    10
    9.8%
    B3 Penetrating
    26
    1.7%
    16
    3.2%
    9
    2.5%
    4
    6%
    2
    2%
    p Perianal disease
    10
    0.7%
    4
    0.8%
    1
    0.3%
    1
    1.5%
    0
    0%
    B2 Stricturing, B3 Penetrating
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS,NP, p Perianal disease
    40
    2.6%
    15
    3%
    11
    3.1%
    5
    7.5%
    6
    5.9%
    B2 Stricturing, p Perianal disease
    14
    0.9%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    B2 Stricturing, B3 Penetrating, p Perianal disease
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B3 Penetrating, p Perianal disease
    27
    1.8%
    20
    4%
    11
    3.1%
    4
    6%
    5
    4.9%
    Missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS, NP
    77
    5.1%
    35
    7.1%
    20
    5.6%
    3
    4.5%
    7
    6.9%
    B2 Stricturing
    47
    3.1%
    8
    1.6%
    15
    4.2%
    3
    4.5%
    9
    8.8%
    B3 Penetrating
    18
    1.2%
    8
    1.6%
    4
    1.1%
    4
    6%
    2
    2%
    p Perianal disease
    4
    0.3%
    3
    0.6%
    1
    0.3%
    1
    1.5%
    0
    0%
    B2 Stricturing, B3 Penetrating
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B1 NS,NP, p Perianal disease
    23
    1.5%
    8
    1.6%
    6
    1.7%
    5
    7.5%
    5
    4.9%
    B2 Stricturing, p Perianal disease
    5
    0.3%
    1
    0.2%
    1
    0.3%
    0
    0%
    0
    0%
    B2 Stricturing, B3 Penetrating, p Perianal disease
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    B3 Penetrating, p Perianal disease
    15
    1%
    12
    2.4%
    10
    2.8%
    2
    3%
    4
    3.9%
    Missing
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    18. Secondary Outcome
    Title Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent
    Description 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.
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 547 144 121 20 30
    E1 Ulcerative proctitis
    41
    2.7%
    10
    2%
    5
    1.4%
    0
    0%
    2
    2%
    E2 Left-sided UC
    151
    9.9%
    26
    5.3%
    30
    8.4%
    3
    4.5%
    8
    7.8%
    E3 Extensive UC
    188
    12.4%
    50
    10.1%
    31
    8.7%
    13
    19.4%
    12
    11.8%
    Missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    E1 Ulcerative proctitis
    31
    2%
    9
    1.8%
    1
    0.3%
    0
    0%
    1
    1%
    E2 Left-sided UC
    109
    7.2%
    23
    4.7%
    24
    6.7%
    3
    4.5%
    6
    5.9%
    E3 Extensive UC
    159
    10.4%
    40
    8.1%
    25
    7%
    12
    17.9%
    13
    12.7%
    Missing
    3
    0.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    E1 Ulcerative proctitis
    17
    1.1%
    7
    1.4%
    4
    1.1%
    0
    0%
    1
    1%
    E2 Left-sided UC
    76
    5%
    21
    4.3%
    13
    3.6%
    3
    4.5%
    7
    6.9%
    E3 Extensive UC
    128
    8.4%
    37
    7.5%
    21
    5.9%
    11
    16.4%
    10
    9.8%
    Missing
    3
    0.2%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    E1 Ulcerative proctitis
    15
    1%
    7
    1.4%
    2
    0.6%
    0
    0%
    2
    2%
    E2 Left-sided UC
    55
    3.6%
    16
    3.2%
    12
    3.4%
    1
    1.5%
    5
    4.9%
    E3 Extensive UC
    96
    6.3%
    29
    5.9%
    18
    5%
    7
    10.4%
    10
    9.8%
    Missing
    2
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    E1 Ulcerative proctitis
    14
    0.9%
    5
    1%
    2
    0.6%
    0
    0%
    0
    0%
    E2 Left-sided UC
    26
    1.7%
    10
    2%
    8
    2.2%
    1
    1.5%
    2
    2%
    E3 Extensive UC
    59
    3.9%
    15
    3%
    15
    4.2%
    4
    6%
    9
    8.8%
    Missing
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    19. Secondary Outcome
    Title Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity
    Description 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).
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 547 144 121 20 30
    S0
    80
    5.3%
    46
    9.3%
    24
    6.7%
    6
    9%
    6
    5.9%
    S1
    75
    4.9%
    17
    3.4%
    18
    5%
    6
    9%
    4
    3.9%
    S2
    147
    9.7%
    14
    2.8%
    19
    5.3%
    3
    4.5%
    9
    8.8%
    S3
    75
    4.9%
    9
    1.8%
    5
    1.4%
    1
    1.5%
    3
    2.9%
    Missing
    3
    0.2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    S0
    122
    8%
    40
    8.1%
    26
    7.3%
    9
    13.4%
    7
    6.9%
    S1
    70
    4.6%
    19
    3.8%
    15
    4.2%
    3
    4.5%
    9
    8.8%
    S2
    74
    4.9%
    7
    1.4%
    6
    1.7%
    3
    4.5%
    3
    2.9%
    S3
    32
    2.1%
    5
    1%
    3
    0.8%
    0
    0%
    1
    1%
    Missing
    4
    0.3%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    S0
    110
    7.2%
    39
    7.9%
    25
    7%
    10
    14.9%
    6
    5.9%
    S1
    58
    3.8%
    16
    3.2%
    5
    1.4%
    1
    1.5%
    8
    7.8%
    S2
    40
    2.6%
    6
    1.2%
    5
    1.4%
    2
    3%
    4
    3.9%
    S3
    11
    0.7%
    3
    0.6%
    3
    0.8%
    1
    1.5%
    0
    0%
    Missing
    5
    0.3%
    2
    0.4%
    0
    0%
    0
    0%
    0
    0%
    S0
    81
    5.3%
    35
    7.1%
    23
    6.4%
    6
    9%
    8
    7.8%
    S1
    41
    2.7%
    11
    2.2%
    5
    1.4%
    0
    0%
    4
    3.9%
    S2
    29
    1.9%
    5
    1%
    2
    0.6%
    2
    3%
    4
    3.9%
    S3
    15
    1%
    1
    0.2%
    2
    0.6%
    0
    0%
    1
    1%
    Missing
    2
    0.1%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    S0
    71
    4.7%
    20
    4%
    17
    4.7%
    3
    4.5%
    7
    6.9%
    S1
    12
    0.8%
    6
    1.2%
    5
    1.4%
    1
    1.5%
    2
    2%
    S2
    12
    0.8%
    3
    0.6%
    1
    0.3%
    1
    1.5%
    2
    2%
    S3
    6
    0.4%
    1
    0.2%
    2
    0.6%
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    20. Secondary Outcome
    Title Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index
    Description 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.
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 969 348 237 47 72
    Remission
    64
    4.2%
    30
    6.1%
    14
    3.9%
    3
    4.5%
    6
    5.9%
    Improvement
    90
    5.9%
    26
    5.3%
    5
    1.4%
    11
    16.4%
    4
    3.9%
    Worsened
    9
    0.6%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unchanged
    19
    1.2%
    2
    0.4%
    3
    0.8%
    2
    3%
    1
    1%
    Not accessible
    4
    0.3%
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    Missing
    5
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Remission
    65
    4.3%
    29
    5.9%
    17
    4.7%
    6
    9%
    8
    7.8%
    Improvement
    62
    4.1%
    23
    4.7%
    3
    0.8%
    9
    13.4%
    4
    3.9%
    Worsened
    12
    0.8%
    1
    0.2%
    3
    0.8%
    1
    1.5%
    0
    0%
    Unchanged
    21
    1.4%
    5
    1%
    3
    0.8%
    0
    0%
    2
    2%
    Not accessible
    4
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Missing
    5
    0.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Remission
    50
    3.3%
    23
    4.7%
    11
    3.1%
    9
    13.4%
    9
    8.8%
    Improvement
    39
    2.6%
    8
    1.6%
    3
    0.8%
    1
    1.5%
    0
    0%
    Worsened
    9
    0.6%
    0
    0%
    0
    0%
    1
    1.5%
    0
    0%
    Unchanged
    20
    1.3%
    8
    1.6%
    3
    0.8%
    3
    4.5%
    2
    2%
    Not accessible
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Missing
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Remission
    36
    2.4%
    16
    3.2%
    9
    2.5%
    6
    9%
    8
    7.8%
    Improvement
    23
    1.5%
    4
    0.8%
    1
    0.3%
    2
    3%
    0
    0%
    Worsened
    5
    0.3%
    1
    0.2%
    0
    0%
    2
    3%
    0
    0%
    Unchanged
    15
    1%
    5
    1%
    3
    0.8%
    2
    3%
    2
    2%
    Not accessible
    0
    0%
    0
    0%
    1
    0.3%
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Remission
    16
    1.1%
    12
    2.4%
    4
    1.1%
    7
    10.4%
    7
    6.9%
    Improvement
    8
    0.5%
    6
    1.2%
    3
    0.8%
    3
    4.5%
    1
    1%
    Worsened
    3
    0.2%
    0
    0%
    2
    0.6%
    0
    0%
    0
    0%
    Unchanged
    8
    0.5%
    3
    0.6%
    3
    0.8%
    1
    1.5%
    2
    2%
    Not accessible
    1
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Missing
    2
    0.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    21. Secondary Outcome
    Title Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24
    Description 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.
    Time Frame Baseline, Months 6, 12, 18 and 24

    Outcome Measure Data

    Analysis Population Description
    FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1516 492 358 67 102
    Baseline
    13.70
    (43.8)
    10.23
    (22.6)
    8.79
    (17.0)
    7.70
    (11.8)
    12.18
    (30.7)
    Change at Month 6
    -1.09
    (47.4)
    1.46
    (40.0)
    -1.45
    (14.6)
    -1.88
    (12.3)
    0.94
    (32.8)
    Change at Month 12
    -4.87
    (38.6)
    -2.23
    (17.3)
    -1.62
    (12.2)
    3.88
    (25.4)
    -4.84
    (30.7)
    Change at Month 18
    -6.57
    (45.2)
    0.63
    (37.7)
    -2.45
    (11.7)
    1.83
    (12.6)
    -0.59
    (51.8)
    Change at Month 24
    0.33
    (177.3)
    -3.51
    (18.2)
    3.19
    (41.7)
    4.17
    (24.6)
    -3.11
    (19.6)
    22. Secondary Outcome
    Title Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24
    Description Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin.
    Time Frame Baseline, Months 6, 12, 18, and 24

    Outcome Measure Data

    Analysis Population Description
    FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1516 492 358 67 102
    Baseline
    1066.31
    (5419.8)
    556.88
    (916.2)
    362.48
    (642.8)
    616.03
    (1023.3)
    537.58
    (1471.9)
    Change at Month 6
    -283.21
    (989.0)
    -296.95
    (958.1)
    -164.60
    (440.8)
    -648.16
    (1333.1)
    224.56
    (700.1)
    Change at Month 12
    -165.32
    (691.9)
    361.51
    (1741.1)
    -289.57
    (1004.9)
    -382.73
    (503.1)
    -643.67
    (2339.3)
    Change at Month 18
    -473.07
    (1394.3)
    275.48
    (1518.0)
    88.44
    (746.8)
    -73.94
    (125.3)
    109.16
    (164.4)
    Change at Month 24
    -625.69
    (1684.7)
    -862.40
    (958.4)
    -494.66
    (1226.4)
    -13.35
    (273.4)
    -450.98
    (200.2)
    23. Secondary Outcome
    Title Number of Participants With Imaging Test Results
    Description Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported.
    Time Frame From baseline up to follow-up period (a maximum of 2 years)

    Outcome Measure Data

    Analysis Population Description
    FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC).
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    Measure Participants 1516 492 358 67 102
    Count of Participants [Participants]
    516
    33.9%
    134
    27.1%
    106
    29.6%
    28
    41.8%
    50
    49%

    Adverse Events

    Time Frame From baseline to follow-up period (up to a maximum duration of 2 years)
    Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.
    Arm/Group Title CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Arm/Group Description Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months. Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.
    All Cause Mortality
    CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/1522 (0.3%) 2/494 (0.4%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Serious Adverse Events
    CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 256/1522 (16.8%) 43/494 (8.7%) 57/358 (15.9%) 10/67 (14.9%) 15/102 (14.7%)
    Blood and lymphatic system disorders
    Anaemia 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Bicytopenia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lymphadenopathy 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lymphopenia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Microcytic anaemia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Neutropenia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Thrombocytopenia 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Cardiac disorders
    Acute myocardial infarction 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Angina unstable 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Atrial fibrillation 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cardiac arrest 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cardiac failure 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cardiovascular disorder 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Myocardial infarction 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Endocrine disorders
    Adrenocorticotropic hormone deficiency 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Steroid withdrawal syndrome 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Thyroid mass 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal disorders
    Abdominal hernia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Abdominal incarcerated hernia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Abdominal pain 11/1522 (0.7%) 0/494 (0%) 3/358 (0.8%) 0/67 (0%) 0/102 (0%)
    Abdominal pain lower 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Abdominal pain upper 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Anal fistula 7/1522 (0.5%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Colitis 13/1522 (0.9%) 0/494 (0%) 1/358 (0.3%) 1/67 (1.5%) 1/102 (1%)
    Colitis ulcerative 13/1522 (0.9%) 3/494 (0.6%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Crohn's disease 23/1522 (1.5%) 5/494 (1%) 6/358 (1.7%) 2/67 (3%) 0/102 (0%)
    Diarrhoea 4/1522 (0.3%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Diarrhoea haemorrhagic 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Diverticulum 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Duodenal stenosis 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Duodenitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Enterocutaneous fistula 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Fistula of small intestine 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastritis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal anastomotic stenosis 2/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal haemorrhage 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Ileal perforation 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Ileal stenosis 11/1522 (0.7%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Ileus 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Inflammatory bowel disease 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Inguinal hernia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Intestinal obstruction 5/1522 (0.3%) 2/494 (0.4%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Intestinal perforation 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Intestinal stenosis 8/1522 (0.5%) 2/494 (0.4%) 1/358 (0.3%) 0/67 (0%) 1/102 (1%)
    Large intestinal stenosis 3/1522 (0.2%) 1/494 (0.2%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Malabsorption 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Nausea 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Obstruction gastric 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Oesophagitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pancreatitis 0/1522 (0%) 1/494 (0.2%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Pancreatitis chronic 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Peptic ulcer perforation 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Small intestinal obstruction 2/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Small intestinal stenosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Subileus 8/1522 (0.5%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Vomiting 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    General disorders
    Adhesion 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Administration site extravasation 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Alcohol withdrawal syndrome 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Chest discomfort 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Condition aggravated 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Drug ineffective 11/1522 (0.7%) 1/494 (0.2%) 5/358 (1.4%) 0/67 (0%) 0/102 (0%)
    Face oedema 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    General physical health deterioration 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hernia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hyperthermia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Impaired healing 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Malaise 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Multiple organ dysfunction syndrome 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Paradoxical drug reaction 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pyrexia 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Stenosis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Sudden death 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hepatobiliary disorders
    Bile duct stone 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Cholangitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cholangitis sclerosing 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Cholecystitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cholelithiasis 2/1522 (0.1%) 2/494 (0.4%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Hepatitis cholestatic 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hepatocellular injury 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lupus hepatitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Immune system disorders
    Anaphylactic reaction 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Colitis ulcerative 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Drug hypersensitivity 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Hypersensitivity 5/1522 (0.3%) 0/494 (0%) 0/358 (0%) 2/67 (3%) 1/102 (1%)
    Sarcoidosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Type I hypersensitivity 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Infections and infestations
    Abdominal abscess 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Abscess 1/1522 (0.1%) 1/494 (0.2%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Abscess intestinal 4/1522 (0.3%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Anal abscess 5/1522 (0.3%) 1/494 (0.2%) 3/358 (0.8%) 0/67 (0%) 0/102 (0%)
    Anal fistula infection 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Appendicitis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Beta haemolytic streptococcal infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Biliary sepsis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Brain abscess 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Breast abscess 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Bronchitis 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Cellulitis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Chronic tonsillitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Clostridium difficile infection 4/1522 (0.3%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Cryptosporidiosis infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Cytomegalovirus colitis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cytomegalovirus infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Disseminated tuberculosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Diverticulitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Epididymitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Epstein-Barr virus infection 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Erysipelas 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Escherichia urinary tract infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Febrile infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Gastroenteritis 1/1522 (0.1%) 2/494 (0.4%) 2/358 (0.6%) 1/67 (1.5%) 1/102 (1%)
    Hepatitis C 0/1522 (0%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Herpes zoster 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Infected fistula 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Liver abscess 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lung infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Measles 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Peritonitis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pneumocystis jirovecii pneumonia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pneumonia 9/1522 (0.6%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Pneumonia influenzal 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Pneumonia legionella 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Post procedural infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Post procedural sepsis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pyelonephritis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pyelonephritis acute 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Respiratory tract infection 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Rotavirus infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Sepsis 0/1522 (0%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Septic shock 2/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Skin infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Staphylococcal sepsis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Subcutaneous abscess 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Subdiaphragmatic abscess 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Tonsillitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Tuberculosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Urinary tract infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Urosepsis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Varicella 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Injury, poisoning and procedural complications
    Anastomotic fistula 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Anastomotic ulcer haemorrhage 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal stoma complication 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Incisional hernia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Infusion related reaction 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Ligament rupture 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Maternal exposure during pregnancy 5/1522 (0.3%) 3/494 (0.6%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Post procedural complication 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Road traffic accident 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Wound 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Investigations
    C-reactive protein increased 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    CSF pressure 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Drug specific antibody present 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Liver function test abnormal 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Weight decreased 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Metabolism and nutrition disorders
    Malnutrition 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Musculoskeletal and connective tissue disorders
    Angiomyolipoma 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Ankylosing spondylitis 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Arthralgia 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 1/67 (1.5%) 0/102 (0%)
    Arthritis enteropathic 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Back pain 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Fistula 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Groin pain 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Intervertebral disc disorder 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Muscle rupture 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Osteonecrosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Rotator cuff syndrome 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Sarcopenia 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Spondylitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Systemic lupus erythematosus 4/1522 (0.3%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Basal cell carcinoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Breast cancer 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Breast cancer in situ 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Chronic lymphocytic leukaemia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal stromal tumour 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Intraductal proliferative breast lesion 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Invasive ductal breast carcinoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lung adenocarcinoma 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Malignant melanoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Prostate cancer 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Seminoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Squamous cell carcinoma 0/1522 (0%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Tongue neoplasm malignant stage unspecified 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Nervous system disorders
    Cerebral infarction 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cerebrovascular accident 0/1522 (0%) 0/494 (0%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Epilepsy 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Headache 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Memory impairment 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Meningioma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Migraine 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Migraine with aura 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Neuropathy peripheral 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Presyncope 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Sciatica 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Seizure 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Syncope 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Transient ischaemic attack 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 1/1522 (0.1%) 3/494 (0.6%) 2/358 (0.6%) 0/67 (0%) 1/102 (1%)
    Foetal death 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Psychiatric disorders
    Depression 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Psychiatric decompensation 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Psychotic disorder 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Schizophrenia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Suicide attempt 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Renal and urinary disorders
    Acute kidney injury 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Bladder disorder 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    IgA nephropathy 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Kidney congestion 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Nephrotic syndrome 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Renal colic 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Renal failure 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Tubulointerstitial nephritis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Reproductive system and breast disorders
    Cervix carcinoma 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Female genital tract fistula 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Fibrocystic breast disease 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gynaecomastia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Ovarian cyst torsion 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Prostatitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Uterine polyp 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Respiratory, thoracic and mediastinal disorders
    Alveolitis allergic 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Asthma 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Chronic obstructive pulmonary disease 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lung disorder 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pneumonia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pulmonary embolism 4/1522 (0.3%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Pulmonary mass 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Respiratory symptom 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Skin and subcutaneous tissue disorders
    Cutaneous vasculitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Dermatitis psoriasiform 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hidradenitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Palmoplantar pustulosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pruritus 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Psoriasis 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Pustular psoriasis 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Pyoderma gangrenosum 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Rash 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Skin reaction 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Surgical and medical procedures
    Caesarean section 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Colectomy 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Ventriculo-peritoneal shunt 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Vascular disorders
    Aneurysm 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Aortic aneurysm rupture 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Behcet's syndrome 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Circulatory collapse 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Femoral artery embolism 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Poor venous access 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Vasculitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Other (Not Including Serious) Adverse Events
    CT-P13 Remicade Switched From Remicade to CT-P13 Switched From CT-P13 to Remicade Multiple Switchers
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 442/1522 (29%) 100/494 (20.2%) 90/358 (25.1%) 7/67 (10.4%) 21/102 (20.6%)
    Blood and lymphatic system disorders
    Anaemia 1/1522 (0.1%) 4/494 (0.8%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Iron deficiency anaemia 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Leukopenia 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lymphadenopathy 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cardiac disorders
    Acute coronary syndrome 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Angina pectoris 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Cardiovascular insufficiency 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Ear and labyrinth disorders
    Neurosensory hypoacusis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Endocrine disorders
    Thyroiditis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Eye disorders
    Dry eye 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Retinal vein occlusion 0/1522 (0%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Scleritis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Vision blurred 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal disorders
    Abdominal pain 3/1522 (0.2%) 1/494 (0.2%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Abdominal tenderness 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Anal fistula 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Colitis 3/1522 (0.2%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Colitis ulcerative 2/1522 (0.1%) 0/494 (0%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Crohn's disease 7/1522 (0.5%) 0/494 (0%) 3/358 (0.8%) 0/67 (0%) 0/102 (0%)
    Diarrhoea 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Enteritis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal anastomotic stenosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal pain 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Haemorrhoids 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Ileal stenosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hiatus hernia 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Intestinal obstruction 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Intestinal stenosis 3/1522 (0.2%) 3/494 (0.6%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Large intestinal stenosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Nausea 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Obstruction gastric 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Oesophagitis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pancreatic failure 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pancreatitis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pouchitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Subileus 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Toothache 0/1522 (0%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Vomiting 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    General disorders
    Drug ineffective 187/1522 (12.3%) 24/494 (4.9%) 23/358 (6.4%) 0/67 (0%) 9/102 (8.8%)
    Dysplasia 0/1522 (0%) 2/494 (0.4%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Fatigue 5/1522 (0.3%) 1/494 (0.2%) 4/358 (1.1%) 0/67 (0%) 0/102 (0%)
    Feeling abnormal 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Fibrosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    General physical health deterioration 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Influenza like illness 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Non-cardiac chest pain 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Oedema peripheral 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pyrexia 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Unevaluable event 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hepatobiliary disorders
    Autoimmune hepatitis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cholelithiasis 1/1522 (0.1%) 0/494 (0%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Cholestasis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hepatic steatosis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Hepatitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hepatocellular injury 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Non-alcoholic steatohepatitis 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Immune system disorders
    Drug hypersensitivity 1/1522 (0.1%) 1/494 (0.2%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Hypersensitivity 29/1522 (1.9%) 10/494 (2%) 4/358 (1.1%) 0/67 (0%) 1/102 (1%)
    Serum sickness 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Type I hypersensitivity 9/1522 (0.6%) 2/494 (0.4%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Infections and infestations
    Abdominal abscess 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Anal abscess 5/1522 (0.3%) 2/494 (0.4%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Anal fistula infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Bronchitis 3/1522 (0.2%) 2/494 (0.4%) 2/358 (0.6%) 0/67 (0%) 1/102 (1%)
    Campylobacter gastroenteritis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Candida infection 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cellulitis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Clostridium difficile infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Conjunctivitis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Cystitis 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Ear infection 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Erysipelas 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Folliculitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Fungal infection 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastroenteritis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gastroenteritis viral 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Gastrointestinal infection 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Genital herpes 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Genital herpes zoster 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Gingivitis 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Groin abscess 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Herpes simplex 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Herpes virus infection 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Herpes zoster 4/1522 (0.3%) 0/494 (0%) 3/358 (0.8%) 0/67 (0%) 0/102 (0%)
    Hordeolum 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Impetigo 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Influenza 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Laryngitis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Latent tuberculosis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lower respiratory tract infection 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 1/67 (1.5%) 0/102 (0%)
    Nail infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Nasopharyngitis 5/1522 (0.3%) 3/494 (0.6%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Onychomycosis 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Ophthalmic herpes simplex 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Opportunistic infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Oral candidiasis 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Oral fungal infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Oral herpes 4/1522 (0.3%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Otitis media acute 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Papilloma viral infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Parvovirus B19 infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Periodontitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pertussis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pneumonia 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pyelonephritis 4/1522 (0.3%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Respiratory tract infection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Rhinitis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Sinusitis 1/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Skin infection 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Subcutaneous abscess 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Tinea cruris 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Tinea pedis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Tinea versicolour 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Tonsillitis 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Tooth abscess 0/1522 (0%) 0/494 (0%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Ureteritis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Urinary tract infection 3/1522 (0.2%) 1/494 (0.2%) 1/358 (0.3%) 1/67 (1.5%) 0/102 (0%)
    Varicella zoster virus infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Viral infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Vulval abscess 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Vulvovaginal mycotic infection 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Injury, poisoning and procedural complications
    Exposure to communicable disease 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Infusion related reaction 24/1522 (1.6%) 3/494 (0.6%) 3/358 (0.8%) 0/67 (0%) 0/102 (0%)
    Limb injury 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Maternal exposure during pregnancy 34/1522 (2.2%) 13/494 (2.6%) 9/358 (2.5%) 0/67 (0%) 1/102 (1%)
    Medication error 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Suture related complication 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Wound 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Wound dehiscence 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Investigations
    Alanine aminotransferase increased 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Aspartate aminotransferase increased 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Blood alkaline phosphatase increased 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Blood count abnormal 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    C-reactive protein increased 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Colonoscopy 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Drug specific antibody present 6/1522 (0.4%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hepatic enzyme increased 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Mean cell volume decreased 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Metabolism and nutrition disorders
    Cell death 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Iron deficiency 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Vitamin B12 deficiency 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 12/1522 (0.8%) 11/494 (2.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Arthritis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Arthropathy 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Back pain 1/1522 (0.1%) 1/494 (0.2%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Lupus-like syndrome 3/1522 (0.2%) 0/494 (0%) 2/358 (0.6%) 0/67 (0%) 0/102 (0%)
    Musculoskeletal discomfort 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Osteonecrosis 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Pain in extremity 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Systemic lupus erythematosus 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Malignant melanoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Malignant melanoma in situ 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Malignant melanoma stage III 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Skin cancer 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Nervous system disorders
    Demyelination 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Dizziness 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Facial paralysis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Headache 2/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Meningioma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Demyelinating polyneuropathy 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 2/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Gestational trophoblastic detachment 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Psychiatric disorders
    Abnormal dreams 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Anxiety 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Depressed mood 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Insomnia 0/1522 (0%) 2/494 (0.4%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Renal and urinary disorders
    Renal failure 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Reproductive system and breast disorders
    Ovarian cyst 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Vaginal haemorrhage 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Cough 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Dyspnoea 1/1522 (0.1%) 1/494 (0.2%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Haemoptysis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Lung disorder 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Nasal discomfort 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Oropharyngeal pain 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 1/67 (1.5%) 0/102 (0%)
    Respiratory distress 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Skin and subcutaneous tissue disorders
    Acne 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Actinic keratosis 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Alopecia 2/1522 (0.1%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Blister 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Dermatitis 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Dermatitis allergic 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Dermatitis atopic 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Dermatitis psoriasiform 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Drug eruption 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Dry skin 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Dyshidrotic eczema 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Eczema 2/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Erythema 3/1522 (0.2%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Erythema nodosum 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hidradenitis 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Ingrowing nail 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Prurigo 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pruritus 0/1522 (0%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Pruritus generalised 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Psoriasis 11/1522 (0.7%) 3/494 (0.6%) 3/358 (0.8%) 0/67 (0%) 0/102 (0%)
    Rash 3/1522 (0.2%) 1/494 (0.2%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Rash erythematous 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 1/67 (1.5%) 0/102 (0%)
    Rebound psoriasis 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Skin lesion 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Skin reaction 18/1522 (1.2%) 1/494 (0.2%) 4/358 (1.1%) 0/67 (0%) 3/102 (2.9%)
    Skin ulcer 0/1522 (0%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 1/102 (1%)
    Urticaria 1/1522 (0.1%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Surgical and medical procedures
    Abortion induced 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Intestinal resection 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Vascular disorders
    Haematoma 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)
    Hot flush 0/1522 (0%) 0/494 (0%) 1/358 (0.3%) 0/67 (0%) 0/102 (0%)
    Poor venous access 1/1522 (0.1%) 0/494 (0%) 0/358 (0%) 0/67 (0%) 0/102 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02539368
    Other Study ID Numbers:
    • ZOB INF 1402
    • C1231001
    First Posted:
    Sep 3, 2015
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Jan 1, 2020