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    Clinical Trial Results:
    A Phase 4, Multicenter, Open-label Study of Serum Infliximab Concentrations and Efficacy and Safety of Dose Escalation in Pediatric Patients With Inflammatory Bowel Disease

    Summary
    EudraCT number
    		 2015-001653-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Aug 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 May 2020
    First version publication date
    26 Jan 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    C0168IBD4020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02566889
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Scientific Affairs
    Sponsor organisation address
    1000 U.S. Route 202 South, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Scientific Affairs, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Scientific Affairs, ClinicalTrialsEU@its.jnj.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of study was to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric subjects with IBD who would benefit (regain clinical response) from dose escalation above the currently approved dose (5 mg/kg every 8 weeks [q8wk])
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations were based upon the type, incidence, and severity of treatment-emergent adverse events (TEAEs) and adverse events (AEs) of special interest reported throughout the study, and on changes in vital sign measurements, clinical laboratory test results, physical examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jan 2016
    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
    Canada: 4
    Country: Number of subjects enrolled
    United States: 49
    Worldwide total number of subjects
    53
    EEA total number of subjects
    0
    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)
    7
    Adolescents (12-17 years)
    46
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 75 subjects were screened out of which 53 subjects were enrolled in the study and a total of 35 subjects completed the study. Reference arm was planned only for safety analysis in subjects being treated with labeled dosing of infliximab.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Reference Group
    Arm description
    		 Subjects received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received infliximab 5 mg/kg infusion q8wk.

    Arm title
    		 Dose Escalation Group
    Arm description
    		 Subjects received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received infliximab 10 mg/kg infusion q8wk.

    Number of subjects in period 1
    		Reference Group Dose Escalation Group
    Started
    45
    8
    Cross-over to Dose escalation Group
    1 [1]
    0 [2]
    Completed
    32
    3
    Not completed
    13
    5
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    4
    2
         Other
    6
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects reported in the baseline period are 53 and the worldwide number of enrolled subjects in the trial is also 53.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only 1 subject was crossed over from Reference group to Dose escalation group instead of all subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Reference Group
    Reporting group description
    		 Subjects received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.

    Reporting group title
    Dose Escalation Group
    Reporting group description
    		 Subjects received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported in the baseline period are 53 and the worldwide number of enrolled subjects in the trial is also 53.
    Reporting group values
    		 Reference Group Dose Escalation Group Total
    Number of subjects
    		 45 8 53
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 5 2 7
        Adolescents (12-17 years)
    		 40 6 46
        Adults (18-64 years)
    		 0 0 0
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.1 ( 1.9 ) 12.9 ( 2.7 ) -
    Title for Gender
    Units: subjects
        Female
    		 16 4 20
        Male
    		 29 4 33

    End points

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    End points reporting groups
    Reporting group title
    Reference Group
    Reporting group description
    		 Subjects received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.

    Reporting group title
    Dose Escalation Group
    Reporting group description
    		 Subjects received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.

    Primary: Clinical Response at Week 16 After Dose Escalation (DE) as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn’s disease (CD) Subjects

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    End point title
    		 Clinical Response at Week 16 After Dose Escalation (DE) as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn’s disease (CD) Subjects [1] [2]
    End point description
    Clinical response: Crohn's disease (CD) subjects with decrease from baseline in PCDAI of greater than or equal to (>=) 15 points with total score of less than or equal to (<=) 30 points. PCDAI included 3 history items (abdominal pain, number of liquid stools, general wellbeing), 5 physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and 3 laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a 3-point scale (0, 5, or 10) except for hematocrit and erythrocyte sedimentation rate which are scored as 0, 2.5 or 5. PCDAI scores can range from 0 to 125 with higher scores indicating more active disease. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since the study was terminated early, no statistical analysis were performed for any primary or secondary endpoints.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [3]
    Units: Subjects
    Notes
    [3] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Primary: Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Subjects

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    End point title
    		 Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Subjects [4] [5]
    End point description
    Clinical Response as per Mayo score was defined as decrease from baseline in partial Mayo score of >= 2 points and >= 30 percent (%) and decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of less than or equal to (<=) 1 point (for UC subjects). A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since the study was terminated early, no statistical analysis were performed for any primary or secondary endpoints.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [6]
    Units: Subjects
    Notes
    [6] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Sustained Clinical Response Through 56 Weeks After Dose Escalation

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    End point title
    		 Sustained Clinical Response Through 56 Weeks After Dose Escalation [7]
    End point description
    Sustained clinical response at Week 56 was defined as achieving clinical response per the primary endpoint definitions at Week 16 and maintaining clinical response at 1 year after dose escalation (Week 56). Clinical response was defined as a decrease from baseline in PCDAI of >= 15 points with total score of =< 30 points (for CD subjects) and a decrease from baseline in partial Mayo score of >=2 points and >=30% and a decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of =< point (for UC subjects). Data for this endpoint was planned to be analyzed for Dose escalation (DE) group only.
    End point type
    Secondary
    End point timeframe
    Up to Week 56
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [8]
    Units: Subjects
        number (not applicable)
    Notes
    [8] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Abdominal Pain and Loose/Watery Stool Frequency Sub-scores of the PCDAI at Week 16 and Week 56 in CD Subjects

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    End point title
    		 Change From Baseline in Abdominal Pain and Loose/Watery Stool Frequency Sub-scores of the PCDAI at Week 16 and Week 56 in CD Subjects [9]
    End point description
    Abdominal and loose/watery stool frequency was evaluated by using the relevant sub-scores of the PCDAI. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 56
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [10]
    Units: Score on a scale
        number (not applicable)
    Notes
    [10] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Abdominal Pain Using the Wong-Baker FACES scale at Week 16 and Week 56 in CD Subjects

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    End point title
    		 Change from Baseline in Abdominal Pain Using the Wong-Baker FACES scale at Week 16 and Week 56 in CD Subjects [11]
    End point description
    Change from baseline in abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in CD subjects was reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The subject must choose the face that best describes how they are feeling. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 56
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [12]
    Units: Score on a scale
        number (not applicable)
    Notes
    [12] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in CD Subjects

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    End point title
    		 Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in CD Subjects [13]
    End point description
    Change from baseline in Absolute stool frequency at Week 16 and Week 56 in CD subjects were reported. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and PGA), rated as 0 (normal) to 3 (severe). Total score was calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3-5=mild; 6-10=moderate; and 11-12=severe; higher scores indicate worsening of the disease. An absolute stool frequency subscore of =<1 point was indicative of mild disease. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 56
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [14]
    Units: Score on a scale
        number (not applicable)
    Notes
    [14] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Subjects

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    End point title
    		 Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Subjects [15]
    End point description
    Change from baseline in Stool frequency sub-score of the partial Mayo score at Week 16 and Week 56 in UC subjects were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute stool frequency subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 and Week 56
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [16]
    Units: Score on a scale
        number (not applicable)
    Notes
    [16] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 And Week 56 in UC Subjects

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    End point title
    		 Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 And Week 56 in UC Subjects [17]
    End point description
    Change from baseline in rectal bleeding sub-scores of the partial Mayo score at Week 16 and Week 56 in UC subjects were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute rectal bleeding subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 And Week 56
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [18]
    Units: Score on a scale
        number (not applicable)
    Notes
    [18] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Subjects

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    End point title
    		 Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Subjects [19]
    End point description
    Change from baseline in Abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in UC subjects were reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The subject must choose the face that best describes how they are feeling. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 And Week 56
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [20]
    Units: Score on a scale
        number (not applicable)
    Notes
    [20] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Subjects

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    End point title
    		 Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Subjects [21]
    End point description
    Change from baseline in Absolute stool frequency at Week 16 and Week 56 in UC subjects were reported. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding [RB], endoscopy findings, and physician's global assessment [PGA]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. An absolute rectal bleeding subscore of <=1 point was indicative of mild disease. Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 And Week 56
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [22]
    Units: Score on a scale
        number (not applicable)
    Notes
    [22] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Correlates of Wong-Baker FACES Scale with Clinical Remission and Response at Week 16

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    End point title
    		 Correlates of Wong-Baker FACES Scale with Clinical Remission and Response at Week 16 [23]
    End point description
    Correlates of Wong-Baker FACES Scale with Clinical Remission and Response at Week 16 was assessed. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [24]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [24] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Secondary: Association Between Abdominal Pain PCDAI Sub-Score And the Wong-Baker Faces Scale For CD Subjects

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    End point title
    		 Association Between Abdominal Pain PCDAI Sub-Score And the Wong-Baker Faces Scale For CD Subjects [25]
    End point description
    Association between abdominal pain PCDAI subscore and Wong-Baker FACES scale for CD subjects was reported. PCDAI is a validated clinical tool used to assess disease severity in pediatric CD subjects. PCDAI collects data on following disease-related variables: Total number of liquid stools, abdominal pain, general well-being (scored by subject or subject’s legal representative); Extra-intestinal manifestations; Physical examinations of abdominal mass and, perirectal disease; Weight change and height change or, height velocity; and Hematocrit, erythrocyte sedimentation rate, and albumin. PCDAI score is calculated as sum of individual component scores and ranges from 0-100 points. Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over age of 3. Scale shows a series of faces ranging from a happy face at 0 "No hurt" to a crying face at 10 "Hurts worst". Data for this endpoint was planned to be analyzed for DE group only.
    End point type
    Secondary
    End point timeframe
    Week 16 and 56
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All endpoints were planned to analyze the Dose Escalation arm only and the Reference arm was planned for safety analysis in subjects being treated with labeled dosing of infliximab. Hence, endpoint is not reporting statistical analysis for all the arms.
    End point values
    		 Dose Escalation Group
    Number of subjects analysed
    0 [26]
    Units: Score on scale
        number (not applicable)
    Notes
    [26] - As study terminated early with fewer subjects than planned, hence data is not summarized.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 64
    Adverse event reporting additional description
    Safety analysis population included all subjects who received at least 1 infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in subjects being treated with infliximab. 1 subject who had crossed-over from reference group to DE group was counted in both arms and safety is presented accordingly.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Reference Group
    Reporting group description
    		 Subjects received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.

    Reporting group title
    Dose Escalation Group
    Reporting group description
    		 Subjects received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.

    Serious adverse events
    		 Reference Group Dose Escalation Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis Streptococcal
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Reference Group Dose Escalation Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 45 (80.00%)
    8 / 9 (88.89%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin Papilloma
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Orthostatic Hypertension
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Chest Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to Arthropod Bite
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Food Allergy
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Ovarian Cyst
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma Exercise Induced
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    Dyspnoea
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    Nasal Congestion
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Oropharyngeal Pain
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 9 (11.11%)
         occurrences all number
    3
    1
    Respiratory Tract Congestion
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Tonsillolith
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    C-Reactive Protein Increased
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Faecal Calprotectin Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Heart Rate Irregular
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Transaminases Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Vitamin D Decreased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Animal Bite
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Burns Second Degree
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Joint Dislocation
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Joint Injury
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    Ligament Sprain
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Limb Injury
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Lip Injury
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Soft Tissue Injury
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness Postural
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    6 / 45 (13.33%)
    1 / 9 (11.11%)
         occurrences all number
    9
    1
    Hemianopia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Eye disorders
    Dry Eye
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 45 (4.44%)
    2 / 9 (22.22%)
         occurrences all number
    5
    4
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Anorectal Disorder
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Colitis Ulcerative
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    5 / 45 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    9
    0
    Epigastric Discomfort
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Faeces Soft
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Lip Swelling
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Mouth Haemorrhage
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Stomatitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Tongue Erythema
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Tooth Disorder
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Tooth Impacted
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Acne Cystic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Blister
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Dry Skin
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Skin Warm
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 45 (8.89%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    Back Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Costochondritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Neck Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Pain in Extremity
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    Synovial Cyst
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Torticollis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Adenovirus Infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Eczema Infected
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Epstein-Barr Virus Infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Eye Infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 9 (11.11%)
         occurrences all number
    1
    2
    Gingivitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Herpes Zoster
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 45 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    6
    0
    Otitis Media
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis Streptococcal
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 9 (0.00%)
         occurrences all number
    3
    0
    Staphylococcal Impetigo
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 45 (6.67%)
    0 / 9 (0.00%)
         occurrences all number
    5
    0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    Viral Infection
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 45 (8.89%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    Vitamin D Deficiency
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2016
    The overall reasons for the amendment are to revise entry criteria regarding prior maintenance doses of infliximab and time of loss of response, and to correct or clarify inadvertent errors.
    07 Dec 2016
    The overall reasons for the amendment are to: Modify the inclusion criteria (for PCDAI and partial Mayo score) to ensure adequate disease severity; Define loss of response; Obtain history of infliximab treatment at initiation, time of response and loss of response, including number of infliximab doses, for the Dose Escalation group; Define “initial response”; Add 2 secondary endpoints (and the corresponding analyses), to evaluate any association between clinical remission/response; Revise wording for several entry criteria, for clarity; Correct or clarify inadvertent errors
    20 Feb 2018
    The overall reasons for the amendment are to: Clarify several entry criteria; Extend the screening period; Add details for corticosteroid tapering; Include complete instructions to ensure safety procedures related to any potential cases of hepatotoxicity; and Update text describing informed consent procedures.

    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.
    The reference arm was planned to monitor the safety characteristics for subjects being treated with labeled dosing of infliximab, hence the endpoint results were not reported for the reference group. 
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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