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    Clinical Trial Results:
    A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease

    Summary
    EudraCT number
    		 2011-002981-19
    Trial protocol
    		 BE   HU   PL  
    Global end of trial date
    29 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2016
    First version publication date
    24 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IM129-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01466374
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation, Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.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
    29 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to assess the efficacy of BMS-936557 for induction of clinical remission (as defined by an absolute Crohn’s Disease Activity Index [CDAI] score <150) as determined by the presence of a relationship between exposure (observed steady-state Cmin) and clinical remission at Week 11.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Dec 2011
    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
    Belgium: 10
    Country: Number of subjects enrolled
    France: 36
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Puerto Rico: 1
    Country: Number of subjects enrolled
    South Africa: 9
    Country: Number of subjects enrolled
    United States: 69
    Worldwide total number of subjects
    195
    EEA total number of subjects
    113
    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)
    189
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 195 subjects were enrolled at 28 sites in 8 countries.

    Pre-assignment
    Screening details
    		 Out of 195 subjects enrolled, 121 were randomised. Of the 74 subjects not randomised, 57 did not meet study criteria, 13 withdrew consent, and 4 experienced an adverse event prior to randomisation.

    Period 1
    Period 1 title
    Induction Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received BMS-936557 matching placebo, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 matching placebo via intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Arm title
    		 BMS-936557 10 mg/kg
    Arm description
    		 Subjects received BMS-936557 10 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-936557
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 10 mg/kg via intravenous infusion over 90 minutes once a week for the first week and every other week thereafter up to 11 weeks.

    Arm title
    		 BMS-936557 20 mg/kg
    Arm description
    		 Subjects received BMS-936557 20 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-936557
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 20 mg/kg via intravenous infusion over 90 minutes once a week for the first week and every other week thereafter up to 11 weeks.

    Number of subjects in period 1 [1]
    		Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Started
    40
    40
    41
    Completed
    39
    32
    35
    Not completed
    1
    8
    6
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    -
    5
    5
         Lack of efficacy
    -
    2
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial as out of 195 subjects who were enrolled only 121 were randomised. 57 subjects no longer met study criteria, 13 subjects withdrew consent, and 4 subjects experienced an adverse event prior to randomisation.
    Period 2
    Period 2 title
    Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo to Placebo
    Arm description
    		 Subjects who received placebo matching with BMS-936557 in the induction period received placebo matching with BMS-936557 intravenous infusion over 90 minutes, every other week for up to 48 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 matching placebo via intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Arm title
    		 BMS-936557 to Placebo
    Arm description
    		 Subjects who received any dose of BMS-936557 in the induction period received BMS-936557 matching placebo via intravenous infusion over 90 minutes, every other week for up to 48 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 matching placebo via intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Arm title
    		 BMS-936557 7.5 mg/kg
    Arm description
    		 Subjects who received any dose of BMS-936557 in the induction period and achieved a clinical response (CR-100) received BMS-936557 7.5 mg/kg, intravenous infusion over 90 minutes, every other week for up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-936557
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 7.5 mg/kg via intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Arm title
    		 BMS-936557 15 mg/kg
    Arm description
    		 Subjects who received any dose of BMS-936557 in the induction period and achieved a clinical response (CR-100) received BMS-936557 15 mg/kg, intravenous infusion over 90 minutes, every other week for up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-936557
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received BMS-936557 15 mg/kg via intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Number of subjects in period 2 [2]
    		Placebo to Placebo BMS-936557 to Placebo BMS-936557 7.5 mg/kg BMS-936557 15 mg/kg
    Started
    13
    11
    12
    11
    Completed
    5
    2
    3
    7
    Not completed
    8
    9
    9
    4
         Consent withdrawn by subject
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    1
    2
    2
         Subject request to discontinue study treatment
    -
    -
    -
    1
         Lost to follow-up
    -
    -
    -
    1
         Lack of efficacy
    5
    5
    3
    -
         Administrative reason by sponsor
    2
    3
    4
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 106 subjects who completed the induction period, 57 subjects continued directly into the open label period and only 47 subjects entered the maintenance phase.
    Period 3
    Period 3 title
    Open-Label Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BMS-936557
    Arm description
    		 Subjects received BMS-936557 15 mg/kg, intravenous infusion over 90 minutes, every other week. Subjects who did not demonstrate clinical response by Open label day 85 (OL-85) were discontinued from the study. Subjects who continued in the study and demonstrated prolonged clinical remission (>3 months) had the option of decreasing the dose to 10 mg/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-936557
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were administered with BMS-936557 15 mg/kg via intravenous infusion over 90 minutes, every other week.

    Number of subjects in period 3 [3]
    		BMS-936557
    Started
    15
    Completed
    10
    Not completed
    74
         Consent withdrawn by subject
    6
         Adverse event, non-fatal
    9
         Subject request to discontinue study treatment
    2
         Pregnancy
    1
         Lost to follow-up
    1
         Poor/non-compliance
    1
         Lack of efficacy
    23
         Administrative reason by sponsor
    31
    Joined
    69
         Subjects continuing directly from induction period
    57
         Discontinued and moving from maintenance period
    12
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 106 subjects who completed the induction period, 57 subjects continued directly into the open label period, 47 subjects entered the maintenance phase, and 2 subjects elected not to continue into the maintenance phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received BMS-936557 matching placebo, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    BMS-936557 10 mg/kg
    Reporting group description
    		 Subjects received BMS-936557 10 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    BMS-936557 20 mg/kg
    Reporting group description
    		 Subjects received BMS-936557 20 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg Total
    Number of subjects
    		 40 40 41 121
    Age categorical
    Units: Subjects
        <65 years
    		 39 39 39 117
        >=65 years
    		 1 1 2 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.3 ( 13.12 ) 35.8 ( 12.96 ) 35.4 ( 13.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 17 21 60
        Male
    		 18 23 20 61

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received BMS-936557 matching placebo, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    BMS-936557 10 mg/kg
    Reporting group description
    		 Subjects received BMS-936557 10 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    BMS-936557 20 mg/kg
    Reporting group description
    		 Subjects received BMS-936557 20 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.
    Reporting group title
    Placebo to Placebo
    Reporting group description
    		 Subjects who received placebo matching with BMS-936557 in the induction period received placebo matching with BMS-936557 intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    BMS-936557 to Placebo
    Reporting group description
    		 Subjects who received any dose of BMS-936557 in the induction period received BMS-936557 matching placebo via intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    BMS-936557 7.5 mg/kg
    Reporting group description
    		 Subjects who received any dose of BMS-936557 in the induction period and achieved a clinical response (CR-100) received BMS-936557 7.5 mg/kg, intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    BMS-936557 15 mg/kg
    Reporting group description
    		 Subjects who received any dose of BMS-936557 in the induction period and achieved a clinical response (CR-100) received BMS-936557 15 mg/kg, intravenous infusion over 90 minutes, every other week for up to 48 weeks.
    Reporting group title
    BMS-936557
    Reporting group description
    		 Subjects received BMS-936557 15 mg/kg, intravenous infusion over 90 minutes, every other week. Subjects who did not demonstrate clinical response by Open label day 85 (OL-85) were discontinued from the study. Subjects who continued in the study and demonstrated prolonged clinical remission (>3 months) had the option of decreasing the dose to 10 mg/kg.

    Primary: Percentage of Subjects in Clinical Remission at Week 11 (IP-78)

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    End point title
    		 Percentage of Subjects in Clinical Remission at Week 11 (IP-78)
    End point description
    Clinical Remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score <150. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extra intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from subject’s diary kept while on study. CDAI scores range from 0 to ~600 points. All subjects who prematurely discontinued for any reason were considered as non-responders/remitters. The analysis was performed in Intent-to-Treat population defined as all the subjects who were randomised and received the study treatment.
    End point type
    Primary
    End point timeframe
    Week 11
    End point values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Number of subjects analysed
    40
    40
    41
    Units: Percentage of subjects
        number (confidence interval 90%)
    20 (9.6 to 30.4)
    22.5 (11.6 to 33.4)
    29.3 (17.6 to 41)
    Statistical analysis title
    		 Treatment difference from Placebo - BMS 10 mg/kg
    Comparison groups
    BMS-936557 10 mg/kg v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.855
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment difference
    Point estimate
    0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.5
         upper limit
    		 15.9
    Statistical analysis title
    		 Treatment difference from Placebo - BMS 20 mg/kg
    Comparison groups
    Placebo v BMS-936557 20 mg/kg
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment difference
    Point estimate
    7.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -8.7
         upper limit
    		 23.8

    Secondary: Percentage of Subjects With Clinical Response at Week 7 (IP-50) and Week 11 (IP-78)

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    End point title
    		 Percentage of Subjects With Clinical Response at Week 7 (IP-50) and Week 11 (IP-78)
    End point description
    Clinical response was defined by a reduction in Crohn's Disease Activity Index (CDAI) >=100 points or absolute CDAI <150 points. The analysis was performed in Intent-to-Treat population defined as all the subjects who were randomised and received the study drug.
    End point type
    Secondary
    End point timeframe
    Week 7 and Week 11
    End point values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Number of subjects analysed
    40
    40
    41
    Units: Percentage of subjects
    number (confidence interval 90%)
        IP-50
    47.5 (34.5 to 60.5)
    45 (32.1 to 57.9)
    53.7 (40.8 to 66.5)
        IP-78
    35 (22.6 to 47.4)
    47.5 (34.5 to 60.5)
    41.5 (28.8 to 54.1)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

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    End point title
    		 Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
    End point description
    IBDQ consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel – symptoms related to primary bowel disturbance, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. The analysis was performed in all the subjects who were randomised and received the study drug. Here, ‘Number of subjects analysed’ signifies subjects evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 11
    End point values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Number of subjects analysed
    37
    37
    40
    Units: units on a scale
        arithmetic mean (standard deviation)
    14.6 ( 33.33 )
    22.5 ( 37.49 )
    32.9 ( 30.69 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs), Related AEs, Discontinuation Due to AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, and Who Died in the Induction Period

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    End point title
    		 Number of Subjects With Adverse Events (AEs), Related AEs, Discontinuation Due to AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, and Who Died in the Induction Period
    End point description
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. The analysis was performed in all the subjects who received the study drug.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 56 days after the last dose of study drug or until the start of a new study period, whichever occured earlier.
    End point values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Number of subjects analysed
    40
    40
    41
    Units: Subjects
        AEs
    31
    26
    24
        Related AEs
    7
    12
    16
        Discontinuation Due to AEs
    0
    5
    5
        SAEs
    2
    3
    4
        Related SAEs
    0
    1
    3
        Discontinuation Due to SAEs
    0
    3
    3
        Death
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Marked Laboratory Abnormalities During Induction Period

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    End point title
    		 Number of Subjects With Marked Laboratory Abnormalities During Induction Period
    End point description
    Hemoglobin Low: <baseline value (PRE) –30 and <Lower limit of normal (LLN); Leukocytes Low: if LLN <=PRE <=limit of normal (ULN) and value <0.75*LLN, or if PRE <LLN and Value <0.8*PRE, or If PRE >ULN and value <LLN; Leukocytes High: If LLN <=PRE <=ULN and value >1.25*ULN, or if PRE <LLN and value >ULN, or if PRE >ULN and value >1.2*PRE. Lymphocytes low (absolute): if value <0.75 and <LLN; Lymphocytes high (absolute): if value >7.5 and >ULN; Neutrophils low (absolute): if value <1.0 and <LLN; Creatinine high: if value >1.5*PRE and >ULN; Albumin low: if LLN <=PRE <=ULN and value <0.9*LLN. The analysis was performed in all the subjects who received the study drug.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 56 days after the last dose of study drug or until the start of a new study period, whichever occured earlier.
    End point values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Number of subjects analysed
    40
    40
    41
    Units: Subjects
        Hemoglobin Low
    0
    0
    1
        Leukocytes Low
    1
    0
    0
        Leukocytes High
    3
    3
    4
        Lymphocytes Low (absolute)
    8
    8
    5
        Neutrophils Low (absolute)
    1
    0
    0
        Creatinine High
    0
    1
    1
        Albumin Low
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Changes in Vital Signs During Induction Period

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    End point title
    		 Number of Subjects With Clinically Significant Changes in Vital Signs During Induction Period
    End point description
    Vital signs included body temperature, heart rate, and blood pressure which were to be taken pre-infusion (no more than 30 minutes pre-infusion), end of infusion, and end of observation. The analysis was performed in all the subjects who received the study drug.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 56 days after the last dose of study drug or until the start of a new study period, whichever occured earlier.
    End point values
    		 Placebo BMS-936557 10 mg/kg BMS-936557 20 mg/kg
    Number of subjects analysed
    40
    40
    41
    Units: Subjects
        Body temperature
    0
    0
    0
        Heart rate
    0
    0
    0
        Blood pressure
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-Treatment period (First dose of study drug up to 56 days after the last dose of study drug)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    IP: Placebo
    Reporting group description
    		 Subjects received BMS-936557 matching placebo, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    IP: BMS 10 mg/kg
    Reporting group description
    		 Subjects received BMS-936557 10 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    IP: BMS 20 mg/kg
    Reporting group description
    		 Subjects received BMS-936557 20 mg/kg, intravenous infusion over 90 minutes, once a week for the first week and every other week thereafter up to 11 weeks.

    Reporting group title
    MP: PLA->PLA
    Reporting group description
    		 Subjects who received placebo matching with BMS-936557 in the induction period received placebo matching with BMS-936557 intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    MP: BMS->PLA
    Reporting group description
    		 Subjects who received any dose of BMS-936557 in the induction period received BMS-936557 matching placebo via intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    MP: BMS 7.5 mg/kg
    Reporting group description
    		 Subjects who received any dose of BMS-936557 in the induction period and achieved a clinical response (CR-100) received BMS-936557 7.5 mg/kg, intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    MP: BMS 15 mg/kg
    Reporting group description
    		 Subjects who received any dose of BMS-936557 in the induction period and achieved a clinical response (CR-100) received BMS-936557 15 mg/kg, intravenous infusion over 90 minutes, every other week for up to 48 weeks.

    Reporting group title
    OL: BMS-936557
    Reporting group description
    		 Subjects received BMS-936557 15 mg/kg, intravenous infusion over 90 minutes, every other week. Subjects who did not demonstrate clinical response by Open label day 85 (OL-85) were discontinued from the study. Subjects who continued in the study and demonstrated prolonged clinical remission (>3 months) had the option of decreasing the dose to 10 mg/kg.

    Serious adverse events
    		 IP: Placebo IP: BMS 10 mg/kg IP: BMS 20 mg/kg MP: PLA->PLA MP: BMS->PLA MP: BMS 7.5 mg/kg MP: BMS 15 mg/kg OL: BMS-936557
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    4 / 41 (9.76%)
    1 / 13 (7.69%)
    2 / 11 (18.18%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    13 / 84 (15.48%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroma
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    7 / 84 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    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
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spondyloarthropathy
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IP: Placebo IP: BMS 10 mg/kg IP: BMS 20 mg/kg MP: PLA->PLA MP: BMS->PLA MP: BMS 7.5 mg/kg MP: BMS 15 mg/kg OL: BMS-936557
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 40 (57.50%)
    18 / 40 (45.00%)
    18 / 41 (43.90%)
    7 / 13 (53.85%)
    9 / 11 (81.82%)
    11 / 12 (91.67%)
    9 / 11 (81.82%)
    50 / 84 (59.52%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    4
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    2
    Influenza like illness
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    4
    1
    0
    0
    1
    1
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    6 / 84 (7.14%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    10
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 41 (4.88%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    4 / 84 (4.76%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    1
    6
    Reproductive system and breast disorders
    Penis disorder
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 41 (2.44%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    0
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 41 (7.32%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    3 / 84 (3.57%)
         occurrences all number
    0
    1
    4
    0
    0
    0
    1
    3
    Laceration
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 40 (7.50%)
    3 / 40 (7.50%)
    2 / 41 (4.88%)
    2 / 13 (15.38%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    4 / 84 (4.76%)
         occurrences all number
    4
    5
    2
    2
    1
    2
    0
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    2
    Vertigo
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    1
    Eye disorders
    Episcleritis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    5 / 84 (5.95%)
         occurrences all number
    1
    1
    0
    0
    0
    2
    0
    5
    Abdominal pain upper
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    3 / 41 (7.32%)
    2 / 13 (15.38%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    2
    1
    3
    2
    1
    0
    0
    2
    Abdominal rigidity
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    1
    1
    Anal fistula
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    3
    Dental caries
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    2
    Dyspepsia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    6 / 84 (7.14%)
         occurrences all number
    1
    0
    4
    0
    2
    0
    0
    6
    Flatulence
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 84 (1.19%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    1
    Nausea
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    7 / 84 (8.33%)
         occurrences all number
    4
    0
    1
    1
    0
    0
    1
    7
    Rectal haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    5 / 84 (5.95%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    2
    3
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Erythema
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    3 / 41 (7.32%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    4 / 84 (4.76%)
         occurrences all number
    1
    3
    1
    0
    0
    0
    0
    5
    Skin lesion
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    5
    0
    0
    1
    1
    0
    2
    Bone pain
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Sacroiliitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    2
    Tendon disorder
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Erysipelas
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 13 (15.38%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    1
    Furuncle
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 13 (15.38%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    2
    Influenza
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    6
    Nasopharyngitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    4 / 84 (4.76%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    4
    Oral herpes
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    2
    Pharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 84 (3.57%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    3
    Rash pustular
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Skin infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 41 (4.88%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
    2 / 12 (16.67%)
    4 / 11 (36.36%)
    8 / 84 (9.52%)
         occurrences all number
    1
    1
    3
    0
    2
    3
    8
    11
    Urinary tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    2
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Iron deficiency
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2011
    The main purpose of this amendment was to permit collection and storage of blood samples for use in future exploratory pharmacogenetic research.
    16 Nov 2011
    The purpose of this amendment was to correct references given in the screening period section, update inclusion criteria and target population, delete and correct the inclusion criteria regarding women of childbearing potential; update exclusion criteria, update the method of assigning subjects; and to revise fourth secondary efficacy endpoint.
    19 Mar 2013
    The main purpose of this amendment was to add severe or serious acute infusion reaction as a reason for discontinuation of treatment and to revise the study drug infusion time.
    29 May 2013
    The main purpose of this amendment was to add interim analysis when approximately 2/3 of subjects are randomised and modification of the induction phase-8 dosing window from -2 to -1 day.
    15 Nov 2013
    The main purpose of this amendment was to increase percentage of biologic experienced subjects to be allowed in the study from 50% to a maximum of approximately 70%, excluding subjects who previously had inadequate response and/or intolerance to 3 more approved biologic agents, add a second year of open label in all sections as appropriate.

    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 study was terminated as sponsor decided not to pursue further clinical development of BMS-936557 due to an insufficient demonstration of efficacy across studies in inflammatory bowel disease (Crohn’s disease and ulcerative colitis).
    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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