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    Clinical Trial Results:
    A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY

    Summary
    EudraCT number
    2014-002056-40
    Trial protocol
    NO  
    Global end of trial date
    16 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Sep 2018
    First version publication date
    08 Sep 2018
    Other versions
    Summary report(s)
    NOR-SWITCH synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    DIA2014-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02148640
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Diakonhjemmet Hospital AS
    Sponsor organisation address
    Diakonveien 12, Oslo, Norway,
    Public contact
    Principal Investigator, Diakonhjemmet Hospital AS, +47 22451500, t.k.kvien@medisin.uio.no
    Scientific contact
    Principal Investigator, Diakonhjemmet Hospital AS, +47 22451500, t.k.kvien@medisin.uio.no
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if biosimilar infliximab (CT-P13) is non-inferior to innovator infliximab (INX) with regard to disease worsening in patients who have been on stable INX treatment for at least 6 months
    Protection of trial subjects
    None
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Oct 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy, Scientific research
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 498
    Worldwide total number of subjects
    498
    EEA total number of subjects
    498
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    425
    From 65 to 84 years
    73
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Each hospital department was considered a study centre, and 19 gastroenterology departments, 16 rheumatology departments, and five dermatology departments from 25 Norwegian hospitals recruited patients to the study.

    Pre-assignment
    Screening details
    Adult patients with a diagnosis of Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or chronic plaque psoriasis on stable treatment with infliximab originator for at least 6 months were eligible for participation.

    Pre-assignment period milestones
    Number of subjects started
    498
    Number of subjects completed
    482

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Protocol deviation: 6
    Reason: Number of subjects
    Physician decision: 4
    Reason: Number of subjects
    Consent withdrawn by subject: 1
    Reason: Number of subjects
    Other reasons: 5
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P13
    Arm description
    Biosimilar infliximab
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab CT-P13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose and infusion intervals of patients’ infliximab treatment regimens were kept unchanged from those before randomisation.

    Arm title
    Originator infliximab
    Arm description
    Originator infliximab
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose and infusion intervals of patients’ infliximab treatment regimens were kept unchanged from those before randomisation.

    Number of subjects in period 1 [1]
    CT-P13 Originator infliximab
    Started
    241
    241
    Completed
    241
    241
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: There was some included patients who were not randomized, resulting in a difference in the numbers.
    Period 2
    Period 2 title
    Intervention
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    Eligible patients with informed consent were randomised in a 1:1 ratio to either continued infliximab originator or switch to CT-P13 treatment, with a computer block randomisation procedure stratified by diagnosis and a fixed block size of six. The computer-generated randomised allocation sequence was imported into the electronic case report form (eCRF) system (Viedoc; version 3.20) and made available exclusively to the study nurse authorised by the local principal investigator to prepare infus

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P13
    Arm description
    Biosimilar infliimab
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab CT-P13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose and infusion intervals of patients’ infliximab treatment regimens were kept unchanged from those before randomisation.

    Arm title
    Originator infliximab
    Arm description
    Originator infliximab
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab CT-P13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose and infusion intervals of patients’ infliximab treatment regimens were kept unchanged from those before randomisation.

    Number of subjects in period 2
    CT-P13 Originator infliximab
    Started
    241
    241
    Completed
    222
    216
    Not completed
    19
    25
         Protocol deviation
    3
    -
         Lack of efficacy
    3
    8
         Other reason
    2
    -
         Adverse event, non-fatal
    6
    8
         Other reasons
    -
    2
         Consent withdrawn by subject
    5
    6
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    Biosimilar infliximab

    Reporting group title
    Originator infliximab
    Reporting group description
    Originator infliximab

    Reporting group values
    CT-P13 Originator infliximab Total
    Number of subjects
    241 241 482
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    48.2 ± 14.9 47.5 ± 14.8 -
    Gender categorical
    Units: Subjects
        Female
    87 99 186
        Male
    154 142 296

    End points

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    End points reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    Biosimilar infliximab

    Reporting group title
    Originator infliximab
    Reporting group description
    Originator infliximab
    Reporting group title
    CT-P13
    Reporting group description
    Biosimilar infliimab

    Reporting group title
    Originator infliximab
    Reporting group description
    Originator infliximab

    Subject analysis set title
    Per protocol set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Consisting of eligible, randomised patients with no major protocol deviations affecting treatment efficacy

    Primary: Disease worsening

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    End point title
    Disease worsening
    End point description
    The primary endpoint was disease worsening during follow-up according to worsening in disease-specific composite measures or a consensus about disease worsening between investigator and patient leading to major change in treatment. Disease worsening according to disease-specific composite measures was defined as change from baseline in Harvey-Bradshaw Index of 4 points or more and a score of 7 points or greater points for Crohn’s disease, change from baseline in Partial Mayo Score of more than 3 and a score of 5 or greater for ulcerative colitis, change from baseline in Ankylosing Spondylitis Disease Activity Score of 1·1 or more attaining a minimum score of 2·1 for spondyloarthritis, change from baseline in Disease Activity Score in 28 joints of 1·2 or more with a minimum score of 3·2 for rheumatoid arthritis and psoriatic arthritis, and change in Psoriasis Area and Severity Index of 3 or more and a score of 5 or greater for chronic plaque psoriasis (appendix p 4).
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    CT-P13 Originator infliximab Per protocol set
    Number of subjects analysed
    206
    202
    408
    Units: Subjects
        Disease worsening
    61
    53
    114
        No disease worsening
    145
    149
    294
    Attachments
    Primary endpoint
    Statistical analysis title
    Primary analysis
    Statistical analysis description
    We analysed the primary outcome and secondary dichotomous endpoints using logistic regression with treatment as fixed effect, adjusted for diagnosis and the treatment duration of infliximab originator at baseline providing estimates (by the delta method) of adjusted risk difference and adjusted relative risk for the treatment difference.
    Comparison groups
    CT-P13 v Originator infliximab
    Number of subjects included in analysis
    408
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Regression, Logistic
    Parameter type
    Risk difference (RD)
    Point estimate
    -4.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.7
         upper limit
    3.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    CT-P13
    Reporting group description
    Biosimilar infliximab

    Reporting group title
    Originator infliximab
    Reporting group description
    Originator infliximab

    Serious adverse events
    CT-P13 Originator infliximab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 240 (8.75%)
    24 / 241 (9.96%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Femoral artery embolism
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Anorectal operation
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic bypass
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicectomy
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Caesarean section
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colectomy
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 241 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal operation
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Photon radiation therapy to prostate
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic operation
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder operation
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysplasia
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Biopsy kidney
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Rheumatoid lung
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Melaena
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    2 / 240 (0.83%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 240 (0.42%)
    2 / 241 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gingival abscess
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 241 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 241 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    CT-P13 Originator infliximab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    164 / 240 (68.33%)
    168 / 241 (69.71%)
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    4 / 240 (1.67%)
    10 / 241 (4.15%)
         occurrences all number
    5
    10
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 240 (2.92%)
    10 / 241 (4.15%)
         occurrences all number
    8
    10
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    13 / 240 (5.42%)
    7 / 241 (2.90%)
         occurrences all number
    14
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 240 (2.50%)
    11 / 241 (4.56%)
         occurrences all number
    6
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    25 / 240 (10.42%)
    23 / 241 (9.54%)
         occurrences all number
    28
    29
    Urinary tract infection
         subjects affected / exposed
    7 / 240 (2.92%)
    14 / 241 (5.81%)
         occurrences all number
    9
    19
    Sinusitis
         subjects affected / exposed
    2 / 240 (0.83%)
    13 / 241 (5.39%)
         occurrences all number
    4
    13
    Influenza
         subjects affected / exposed
    7 / 240 (2.92%)
    7 / 241 (2.90%)
         occurrences all number
    7
    7
    Respiratory tract infection
         subjects affected / exposed
    10 / 240 (4.17%)
    4 / 241 (1.66%)
         occurrences all number
    11
    4
    Gastroenteritis
         subjects affected / exposed
    6 / 240 (2.50%)
    7 / 241 (2.90%)
         occurrences all number
    6
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2015
    This amendment added exclusion criteria 6: "For patients with UC and CD: Functional colostomy or ileostomy. Extensive colonic resection with less than 25 cm of the colon left in situ." In addition, the protocol was amended to enable further recording of background demographic information for each patient.
    21 Jul 2015
    This amendment added details of a 26-week open-label extension with CT-P13 to the study.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28502609
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