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    Clinical Trial Results:
    A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease

    Summary
    EudraCT number
    2019-001087-30
    Trial protocol
    LV   CZ   SK   FR   PL   DE   GR   HU   ES   AT   BG   HR   IT   RO  
    Global end of trial date
    22 Aug 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Mar 2024
    First version publication date
    23 Mar 2024
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CT-P13_3.8
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03945019
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Celltrion Inc.
    Sponsor organisation address
    23 Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014
    Public contact
    Yun Ju Bae, Celltrion, Inc, 82 328504160, yunju.bae@celltrion.com
    Scientific contact
    Yun Ju Bae, Celltrion, Inc, 82 328504160, yunju.bae@celltrion.com
    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
    03 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of CT-P13 SC over Placebo SC based on clinical remission and endoscopic response at Week 54.
    Protection of trial subjects
    Hypersensitivity monitoring (including delayed hypersensitivity) was assessed by vital signs (including blood pressure, heart and respiratory rates, and body temperature) at the following time points at each visit specified in the schedule of events. - Prior to the beginning of study drug administration - Within 15 minutes after the end of study drug administration - 1 hour (+10 minutes) after the end of study drug administration If patients had signs and symptoms of hypersensitivity at home (such as but not limited to skin rash, hives, difficulty breathing, or swelling of face, lips, or mouth, or swelling of the hands, feet, or ankles), patients or caregivers were advised to call the study center or get immediate help. In addition, hypersensitivity was monitored by routine continuous clinical monitoring including patient-reported signs and symptoms. In case of hypersensitivity, emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilation, were available; in addition, any type of ECG could have been performed. For patients who experienced or developed life-threatening treatment-related anaphylactic reactions, study drug was stopped immediately, and the patient was withdrawn from the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Jul 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 97
    Country: Number of subjects enrolled
    Romania: 3
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Croatia: 17
    Country: Number of subjects enrolled
    Bulgaria: 11
    Country: Number of subjects enrolled
    Czechia: 13
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hungary: 12
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Latvia: 3
    Country: Number of subjects enrolled
    Belarus: 6
    Country: Number of subjects enrolled
    India: 6
    Country: Number of subjects enrolled
    Israel: 20
    Country: Number of subjects enrolled
    Japan: 6
    Country: Number of subjects enrolled
    Mexico: 15
    Country: Number of subjects enrolled
    Moldova, Republic of: 1
    Country: Number of subjects enrolled
    Peru: 4
    Country: Number of subjects enrolled
    Russian Federation: 70
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    South Africa: 7
    Country: Number of subjects enrolled
    Türkiye: 2
    Country: Number of subjects enrolled
    Ukraine: 45
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    396
    EEA total number of subjects
    194
    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)
    388
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 787 patients from 148 study centers in 26 countries were screened and 396 patients from 114 study centers in 26 countries were enrolled in this study.

    Pre-assignment
    Screening details
    Male or female aged 18 to 75 years old, inclusive, with moderately to severely active CD who had a CDAI score of 220 to 450 points at screening and had an inadequate response to conventional therapy were considered for enrollment in the study if they met all the inclusion criteria and none of the exclusion criteria.

    Period 1
    Period 1 title
    Induction phase
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    CT-P13 IV 5 mg/kg
    Arm description
    Patient treated with CT-P13 IV 5 mg/kg at Weeks 0, 2 and 6
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction dose of CT-P13 5 mg/kg via IV infusion at Weeks 0, 2 and 6

    Number of subjects in period 1
    CT-P13 IV 5 mg/kg
    Started
    396
    Completed
    343
    Not completed
    53
         Physician decision
    1
         Consent withdrawn by subject
    12
         Death
    1
         Adverse event
    11
         Progressive disease
    2
         Non-responder at Week 10
    22
         Lost to follow-up
    2
         Protocol deviation
    2
    Period 2
    Period 2 title
    Maintenance phase
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This study had a double blind maintenance phase, the treatment assignment for the maintenance phase was blinded to the investigators, patients, and predefined CELLTRION, Inc. and CRO blinded teams until the final CSR was generated. The blind could be broken only if specific emergency treatment would be dictated by knowing the study drug assignment was required for medical management.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P13 SC 120 mg
    Arm description
    Patient treated with CT-P13 SC 120 mg every 2 weeks from Week 10 through Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima SC, Zymfentra
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CT-P13 120 mg SC via pre-filled syringe

    Arm title
    Placebo
    Arm description
    Patient treated with placebo SC every 2 weeks from Week 10 through Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC via pre-filled syringe

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: All patients were randomized after completion of period 1. Patients in Period 2 are considered as baseline as objective of this study was to demonstrate superiority of CT-P13 SC over Placebo
    Number of subjects in period 2 [2]
    CT-P13 SC 120 mg Placebo
    Started
    231
    112
    Completed
    192
    86
    Not completed
    39
    26
         Physician decision
    7
    5
         Consent withdrawn by subject
    7
    8
         Death
    1
    -
         Pregnancy
    1
    -
         Adverse event
    8
    6
         Progressive disease
    13
    6
         Lost to follow-up
    1
    1
         Protocol deviation
    1
    -
    Notes
    [2] - 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: All patients were randomized after completion of period 1. Patients in Period 2 are considered as baseline as objective of this study was to demonstrate superiority of CT-P13 SC over Placebo
    Period 3
    Period 3 title
    Extension phase
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CT-P13 SC 120 mg
    Arm description
    In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS or auto-injector (AI) from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima SC, Zymfentra
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CT-P13 120 mg SC via pre-filled syringe or auto-injector

    Arm title
    Placebo
    Arm description
    In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS or auto-injector (AI) from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    CT-P13
    Investigational medicinal product code
    Other name
    Remsima SC, Zymfentra
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    CT-P13 120 mg SC via pre-filled syringe or auto-injector

    Number of subjects in period 3
    CT-P13 SC 120 mg Placebo
    Started
    192
    86
    Completed
    166
    75
    Not completed
    26
    11
         Physician decision
    1
    -
         Consent withdrawn by subject
    10
    4
         Other
    -
    1
         Adverse event
    6
    3
         Progressive disease
    5
    2
         Lost to follow-up
    4
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CT-P13 SC 120 mg
    Reporting group description
    Patient treated with CT-P13 SC 120 mg every 2 weeks from Week 10 through Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Patient treated with placebo SC every 2 weeks from Week 10 through Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group values
    CT-P13 SC 120 mg Placebo Total
    Number of subjects
    231 112 343
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    225 111 336
        From 65-84 years
    6 1 7
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.0 ± 12.53 32.3 ± 11.53 -
    Gender categorical
    Units: Subjects
        Female
    97 43 140
        Male
    134 69 203
    Race
    Units: Subjects
        American Indian or Alaska Native
    8 5 13
        Asian
    9 4 13
        Black or African American
    1 0 1
        White
    211 101 312
        Other
    2 2 4

    End points

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    End points reporting groups
    Reporting group title
    CT-P13 IV 5 mg/kg
    Reporting group description
    Patient treated with CT-P13 IV 5 mg/kg at Weeks 0, 2 and 6
    Reporting group title
    CT-P13 SC 120 mg
    Reporting group description
    Patient treated with CT-P13 SC 120 mg every 2 weeks from Week 10 through Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Patient treated with placebo SC every 2 weeks from Week 10 through Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.
    Reporting group title
    CT-P13 SC 120 mg
    Reporting group description
    In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS or auto-injector (AI) from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Reporting group title
    Placebo
    Reporting group description
    In the open-label extension phase, all patients who completed the maintenance phase up to Week 54 and may benefit from continued treatment, in the opinion of the investigator, received active treatment with CT-P13 SC 120 mg via PFS or auto-injector (AI) from Week 56. The patients who received the adjusted dose of CT-P13 SC 240 mg in the Maintenance Phase continued receiving the same doses of CT-P13 SC for the study treatment in the Extension Phase. Patients who initially responded but then lost response could increase the dose to CT-P13 SC 240mg (double injection [2 shots] of CT-P13 SC 120 mg) every 2 weeks.

    Primary: Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54

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    End point title
    Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
    End point description
    Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
    End point type
    Primary
    End point timeframe
    Week 54
    End point values
    CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    231
    112
    Units: Number of subjects
    144
    36
    Statistical analysis title
    Clinical Remission
    Comparison groups
    CT-P13 SC 120 mg v Placebo
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Primary: Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54

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    End point title
    Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
    End point description
    Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.
    End point type
    Primary
    End point timeframe
    Week 54
    End point values
    CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    231
    112
    Units: Number of subjects
    118
    20
    Statistical analysis title
    Endoscopic response
    Comparison groups
    CT-P13 SC 120 mg v Placebo
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Patients Achieving CDAI-100 Response at Week 54

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    End point title
    Percentage of Patients Achieving CDAI-100 Response at Week 54
    End point description
    Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    231
    112
    Units: Number of subjects
    152
    43
    No statistical analyses for this end point

    Secondary: Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54

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    End point title
    Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
    End point description
    Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    231
    112
    Units: Number of subjects
    131
    35
    No statistical analyses for this end point

    Secondary: Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54

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    End point title
    Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
    End point description
    Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of >1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    CT-P13 SC 120 mg Placebo
    Number of subjects analysed
    231
    112
    Units: Number of subjects
    80
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-Emergent Adverse Events for CT-P13 IV 5 mg/kg group during induction phase (Week 0 to 10), CT-P13 SC 120 mg and placebo groups during the maintenance phase (from Week 10 to Week 54) and extension phase (From Week 56 to Week 102) were reported.
    Adverse event reporting additional description
    Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC 120 mg and Placebo groups, the safety analyses were performed in the safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    CT-P13 IV 5 mg/kg - Induction
    Reporting group description
    Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.

    Reporting group title
    CT-P13 SC 120 mg - Maintenance
    Reporting group description
    Patients who administered CT-P13 SC 120 mg every 2 weeks from Week 10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.

    Reporting group title
    Placebo - Maintenance
    Reporting group description
    Patients who administered Placebo every 2 weeks from Week 10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.

    Reporting group title
    CT-P13 SC 120 mg - Extension
    Reporting group description
    Patients who administered CT-P13 SC 120 mg every 2 weeks from Week 56 to Week 102. Patients who received adjusted dose of CT-P13 SC 240mg are also included.

    Reporting group title
    Placebo - Extension
    Reporting group description
    Patients who administered Placebo every 2 weeks from Week 10 to Week 54, followed by CT-P13 SC 120 mg every 2 weeks from Week 56 to Week 102. For patients who received adjusted dose of CT-P13 SC 240mg are included.

    Serious adverse events
    CT-P13 IV 5 mg/kg - Induction CT-P13 SC 120 mg - Maintenance Placebo - Maintenance CT-P13 SC 120 mg - Extension Placebo - Extension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 396 (3.03%)
    15 / 238 (6.30%)
    8 / 105 (7.62%)
    16 / 238 (6.72%)
    4 / 105 (3.81%)
         number of deaths (all causes)
    1
    1
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer stage III
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammatory pseudotumour
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    2 / 396 (0.51%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurovascular conflict
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    6 / 396 (1.52%)
    3 / 238 (1.26%)
    1 / 105 (0.95%)
    1 / 238 (0.42%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery embolism
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Short-bowel syndrome
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne fulminans
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 396 (0.25%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bartholinitis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal tuberculosis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 396 (0.25%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 396 (0.51%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tick-borne viral encephalitis
         subjects affected / exposed
    0 / 396 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 396 (0.00%)
    1 / 238 (0.42%)
    0 / 105 (0.00%)
    0 / 238 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CT-P13 IV 5 mg/kg - Induction CT-P13 SC 120 mg - Maintenance Placebo - Maintenance CT-P13 SC 120 mg - Extension Placebo - Extension
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 396 (8.84%)
    51 / 238 (21.43%)
    27 / 105 (25.71%)
    38 / 238 (15.97%)
    15 / 105 (14.29%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 396 (4.55%)
    18 / 238 (7.56%)
    5 / 105 (4.76%)
    3 / 238 (1.26%)
    3 / 105 (2.86%)
         occurrences all number
    23
    31
    14
    5
    7
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    10 / 396 (2.53%)
    11 / 238 (4.62%)
    17 / 105 (16.19%)
    8 / 238 (3.36%)
    4 / 105 (3.81%)
         occurrences all number
    13
    12
    17
    9
    4
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 396 (2.53%)
    22 / 238 (9.24%)
    5 / 105 (4.76%)
    29 / 238 (12.18%)
    10 / 105 (9.52%)
         occurrences all number
    10
    22
    5
    30
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 May 2019
    • New sections for New York Heart Association Functional Classification and drug-induced liver injury monitoring added to the protocol • Cardiovascular, tuberculosis, PK, usability, safety assessment details were modified • General and TB exclusion criteria were updated to include detailed exclusion criteria of hepatitis C and TB • Changed some phrases in study design for clarification and specified which teams will be unblinded • Study design, figures and treatment period sections were updated to clarify which patients will go through the dose adjustment and which treatment the patients will receive during the extension phase • Treatment period section was updated to clarify how dose adjusted patients will be analyzed • Study design for induction and maintenance phase and figure were updated to explain when the additional PK sampling visits will occur as well as changed some phrases for clarification • Added a secondary endpoint to aid in establishing remission thresholds for AP and loose SF and other secondary endpoints were edited to clarify the definition of sustained clinical remission • Added a statement to include detailed role of DSMB in safety monitoring • Changed statistical analysis method per regulatory agency’s recommendation as well as added a statement in efficacy analysis section to clarify how dose adjusted patients will be analyzed • Added a statement to clarify which colonoscopy reading results will be used for a statistical testing as well as a statement to clarify how dose adjusted patients will be analyzed • Patient withdrawal and discontinuation details were revised • Training for self-Injection was modified to correspond with the current regulatory guidelines • Added a hypersensitivity monitoring point for patients who will self-inject the study drug • Physical examination details and definitions of AESIs were modified to correspond with the current regulatory guidelines
    26 Jul 2019
    • Section added for guidelines for individual patient withdrawal criteria • Added an appendix to specify objective individual stopping criteria based on the known safety profile and mechanism of action of the drug • Added statement in study overview and treatments administered sections and schedule of events table to clarify that the Week 56 visit will be only reserved for the patients who will self-inject CT-P13 SC via AI • Repetitive text removed from protocol section withdrawal of patients from the study • Withdrawal of patients from the study section was updated to remove repetitive text and to clarify detailed role of DSMB for safety monitoring • Contacts details of analytical facilities were updated • Text was revised to include detailed overall study stopping criteria and its associated roles of DSMB
    29 Oct 2019
    • Increased the number of centers for study conduct • Clinical studies updated with the most current data in the introduction section • Previous exposure to biologic agent and/or JAK inhibitors added as stratification for randomization and as an exclusion criterion • Week 56 visit was only reserved for the patients who self-inject CT-P13 SC via AI • Changed to shorter period since no significant effect on the efficacy results; this also facilitates patient enrollment for oral budesonide • New section and appendix added to clarify premature discontinuation of patients and to include guidelines for individual patient withdrawal criteria • Added a statement to include detailed roles of DSMB • Clarification added for dose adjustment • Clarification added that blood samples for PK and immunogenicity analysis are to be collected before study drug administration • Clarification added on tapering of corticosteroids and oral budesonide • Assessment schedule for Ctrough changed from Week 52 to Week 100 • Clarification added for PK sample collation for dose adjustment • Additional usability endpoint and assessment as “device integrity” for PFS and AI added • Additional hypersensitivity assessment timeframe added • Added definition and assessment details for ADE and serious ADE • Added additional Medical Affairs/Pharmacovigilance content details for SAE reporting • Added additional requirement to report the SAEs associated with device to the regulatory authorities • Reduced the timeframe from 1 hour to 15 minutes to collate the patient’s assessment of local site pain after the end of administration of study drug • Updated the schedule of events tables for induction, maintenance, and extension phases in accordance with the corresponding updates within the protocol
    27 Apr 2020
    • Sample size and key secondary effect size were modified based on adjusted statistical power considering sponsor’s risk assessment. Additionally, non-responder rate was modified referring to current Crohn’s disease studies of CT-P13
    03 Aug 2020
    • Deleted the table with analytical facility details since its information was duplicated in the ICF • Explanation added on how the number of enrolled patients could vary • General exclusion criteria updated in consideration of the risk assessment of each infection • General exclusion criteria for drug or alcohol abuse updated in consideration of the risk assessment • Clinical studies updated with the most current data in the introduction section • Clarification added for the reason for patient withdrawal • Clarification added for prohibited therapies • Clarification added on how laboratory results are to be collected • Text added to allow the usage of external colonoscopy video at screening • Text added to allow retest of clinical laboratory assessments at screening • Text added to clarify the purpose of additional blood sampling for PK PD modeling • Text added to clarify how immunoassay is to be conducted • As the feasibility of FC sampling and handling at all sites was confirmed some text for sampling and handling of FC at qualified or feasible sites removed • Study blinding section updated based on the internal sponsor standard operating procedure • Updated the schedule of events tables for induction, maintenance, and extension phases in accordance with the corresponding updates within the protocol

    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
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