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    Clinical Trial Results:
    A Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of PF 00547659 in Subjects With Crohn’s Disease (OPERA)

    Summary
    EudraCT number
    		 2010-023437-30
    Trial protocol
    		 SK   BE   SE   AT   DE   PT   NO   NL   ES   PL   BG  
    Global end of trial date
    09 Oct 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A7281006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01276509
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Call Center, ClinicalTrial.gov, 1 667181021, ClinicalTrials.gov.inquiries@pfizer.com
    Scientific contact
    Call Center, ClinicalTrial.gov, 1 667181021, ClinicalTrials.gov_Inquiries@pfizer.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
    09 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the number of subjects that experienced a decrease in Crohn’s Disease Activity Index (CDAI) of at least 70 points by the Week 8 or Week 12 assessment.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Netherlands: 29
    Country: Number of subjects enrolled
    Norway: 5
    Country: Number of subjects enrolled
    Serbia: 14
    Country: Number of subjects enrolled
    Slovakia: 9
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    United States: 82
    Country: Number of subjects enrolled
    Poland: 15
    Worldwide total number of subjects
    262
    EEA total number of subjects
    135
    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)
    259
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted at 103 centers in Austria (1), Bulgaria (2), Belgium (3), Canada (3), France (8), Germany (8), Japan (7), Korea (7), Netherlands (3), Norway (3), Poland (4), Serbia (4), Slovakia (4), South Africa (3), Spain (6), and the US (37). Male and/or female subjects between the ages of 18 and 75 years were included in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-00547659 22.5 mg
    Arm description
    		 PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.

    Arm title
    		 PF-00547659 75 mg
    Arm description
    		 PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks.

    Arm title
    		 PF-00547659 225 mg
    Arm description
    		 PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo delivered SC, 3 doses separated by 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo delivered SC, 3 doses separated by 4 weeks.

    Number of subjects in period 1
    		PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo
    Started
    66
    65
    68
    63
    Completed
    53
    53
    63
    58
    Not completed
    13
    12
    5
    5
         Consent withdrawn by subject
    1
    2
    -
    -
         Adverse event, non-fatal
    9
    8
    4
    3
         Pregnancy
    1
    -
    -
    -
         Unspecified
    -
    1
    -
    -
         Lack of efficacy
    2
    1
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-00547659 22.5 mg
    Reporting group description
    		 PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 75 mg
    Reporting group description
    		 PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 225 mg
    Reporting group description
    		 PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo delivered SC, 3 doses separated by 4 weeks.

    Reporting group values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo Total
    Number of subjects
    		 66 65 68 63 262
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 64 65 68 62 259
        From 65-84 years
    		 2 0 0 1 3
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.3 ( 13 ) 34.4 ( 10.7 ) 35.9 ( 11 ) 34.4 ( 11.1 ) -
    Gender, Male/Female
    Units: Participants
        FEMALE
    		 48 35 43 30 156
        MALE
    		 18 30 25 33 106

    End points

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    End points reporting groups
    Reporting group title
    PF-00547659 22.5 mg
    Reporting group description
    		 PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 75 mg
    Reporting group description
    		 PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 225 mg
    Reporting group description
    		 PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo delivered SC, 3 doses separated by 4 weeks.

    Primary: Percentage of Subjects With Crohn's Disease Activity Index (CDAI) Response Rate

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    End point title
    		 Percentage of Subjects With Crohn's Disease Activity Index (CDAI) Response Rate
    End point description
    Crohn's Disease Activity Index (CDAI) 70 response rate at week 8 or week 12 (between the investigational product group and the placebo group). The full analysis set included all randomized subjects who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Week 8 and week 12
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo
    Number of subjects analysed
    66
    65
    68
    63
    Units: Percentage of Subjects
    number (not applicable)
        Week 8 (n =50, 55, 62, 56)
    52.7
    60.1
    62.7
    47.7
        Week 12 (n = 51, 49, 61, 54)
    62
    64.7
    57.5
    58.6
    Statistical analysis title
    		 Difference from placebo at Week 8
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 22.5 mg v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3393
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.149
         upper limit
    		 0.249
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.121
    Statistical analysis title
    		 Difference from placebo at Week 8
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 75 mg v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1433
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.124
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.068
         upper limit
    		 0.316
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.117
    Statistical analysis title
    		 Difference from placebo at Week 8
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 225 mg v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0922
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.036
         upper limit
    		 0.335
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.113
    Statistical analysis title
    		 Difference from placebo at Week 12
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 22.5 mg v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3864
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.034
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.158
         upper limit
    		 0.225
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.117
    Statistical analysis title
    		 Difference from placebo at Week 12
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 75 mg v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3005
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.061
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.131
         upper limit
    		 0.253
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.117
    Statistical analysis title
    		 Difference from placebo at Week 12
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 225 mg v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5385
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.011
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.198
         upper limit
    		 0.176
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.114

    Secondary: Safety and Tolerability of PF‑00547659 Dose Levels versus Placebo

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    End point title
    		 Safety and Tolerability of PF‑00547659 Dose Levels versus Placebo
    End point description
    Number of subjects with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported by all causalities and treatment related. The safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 12
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo
    Number of subjects analysed
    66
    65
    68
    63
    Units: Subjects
        Number of AEs (all causalities)
    175
    192
    190
    141
        Number of AEs (treatment related)
    40
    55
    64
    40
        Subjects with AEs (all causalities)
    57
    51
    54
    54
        Subjects with AEs (treatment related)
    20
    24
    29
    22
        Withdrawal due to AEs (all causalities)
    9
    8
    4
    3
        Withdrawal due to AEs (treatment related)
    5
    2
    0
    1
        Subjects with SAEs (all causalities)
    11
    9
    11
    5
        Subjects with SAEs (treatment related)
    4
    4
    2
    2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with a Crohn's Disease Activity Index (CDAI) Remission

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    End point title
    		 Percentage of Subjects with a Crohn's Disease Activity Index (CDAI) Remission
    End point description
    Percentage of subjects with a CDAI remission (defined as a CDAI reduction to <150 points). The full analysis set included all randomized subjects who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Weeks 8 and week 12
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo
    Number of subjects analysed
    66
    65
    68
    63
    Units: Percentage of subjects
    number (not applicable)
        Week 8 (n = 50, 56, 62, 57)
    29.1
    23.8
    26.9
    16.7
        Week 12 (n= 51, 49, 61, 55)
    26.8
    28.5
    29.6
    23
    Statistical analysis title
    		 Difference from placebo at week 8
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 22.5 mg v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1234
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.124
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.052
         upper limit
    		 0.299
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.107
    Statistical analysis title
    		 Difference from placebo at week 8
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 75 mg v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2378
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.071
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.092
         upper limit
    		 0.234
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.099
    Statistical analysis title
    		 Difference from placebo at week 8
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 225 mg v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1529
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.102
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.062
         upper limit
    		 0.266
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Difference from placebo at week 12
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 22.5 mg v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3661
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.038
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.146
         upper limit
    		 0.222
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.112
    Statistical analysis title
    		 Difference from placebo at week 12
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 75 mg v Placebo
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3169
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.055
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.136
         upper limit
    		 0.246
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.116
    Statistical analysis title
    		 Difference from placebo at week 12
    Statistical analysis description
    The full analysis set included all randomized subjects who received at least one dose of study medication.
    Comparison groups
    PF-00547659 225 mg v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2755
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.066
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.116
         upper limit
    		 0.248
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.111

    Secondary: Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time

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    End point title
    		 Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
    End point description
    Percentage of subjects with Crohn's Disease Activity Index (CDAI)-70 response were reported. The full analysis set included all randomized subjects who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 6, 8, 10 and 12
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo
    Number of subjects analysed
    66
    65
    68
    63
    Units: Percentage of subjects
    number (confidence interval 90%)
        Week 2 (n = 64, 60, 63, 60)
    35.1 (22.8 to 49.6)
    22.4 (12.9 to 36)
    33.8 (21.6 to 48.5)
    35.5 (22.9 to 50.5)
        Week 4 (n = 58, 60, 65, 58)
    38 (24.9 to 53.2)
    39.5 (26.3 to 54.4)
    36.2 (23.7 to 51)
    38.3 (25.1 to 53.5)
        Week 6 (n =56, 54, 64, 58)
    45.3 (31.1 to 60.3)
    53.4 (38.2 to 67.9)
    47.5 (33.3 to 62.1)
    48 (33.5 to 62.9)
        Week 8 (n =50, 55, 62, 56)
    52.7 (37.2 to 67.7)
    60.1 (44.9 to 73.6)
    62.7 (47.9 to 75.4)
    47.7 (33.1 to 62.7)
        Week 10 (n =50, 48, 60, 52)
    67.4 (52 to 79.7)
    58.2 (42.3 to 72.6)
    61.6 (46.8 to 74.6)
    53 (37.6 to 67.8)
        Week 12 (n = 51, 49, 61, 54)
    62 (46.5 to 75.3)
    64.7 (48.9 to 77.8)
    57.5 (42.6 to 71.2)
    58.6 (43.3 to 72.4)
    No statistical analyses for this end point

    Secondary: Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer

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    End point title
    		 Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
    End point description
    Percentage of subjects with Crohn's Disease Activity Index (CDAI)-100 response were reported. The full analysis set included all randomized subjects who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 6, 8, 10 and 12
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Placebo
    Number of subjects analysed
    66
    65
    68
    63
    Units: Percentage of subjects
    number (confidence interval 90%)
        Week 2 (n = 64, 60, 63, 60)
    19.3 (10.6 to 32.6)
    18.4 (9.9 to 31.7)
    20 (11 to 33.6)
    18.5 (9.9 to 31.9)
        Week 4 (n = 58, 60 ,65, 58)
    29.2 (17.5 to 44.6)
    32.3 (20 to 47.5)
    28.2 (17 to 43)
    29.5 (17.7 to 44.9)
        Week 6 (n =56, 54, 64, 58)
    40.6 (26.6 to 56.4)
    42.6 (28.2 to 58.5)
    40.4 (26.8 to 55.8)
    39.3 (25.5 to 55)
        Week 8 (n = 50, 55, 62, 56)
    50.5 (34.8 to 66.2)
    48.3 (33.3 to 63.7)
    57 (41.8 to 71)
    41.4 (27.2 to 57.3)
        Week 10 (n = 50, 48, 62, 52)
    53.2 (37.3 to 68.5)
    47.4 (31.8 to 63.5)
    50.9 (35.9 to 65.7)
    43.6 (28.7 to 59.7)
        Week 12 (n = 51, 49, 61, 54)
    56 (40.1 to 70.7)
    47.7 (32.2 to 63.7)
    53.8 (38.7 to 68.4)
    44.4 (29.6 to 60.2)
    No statistical analyses for this end point

    Secondary: Immunogenicity Assessment of Anti-drug Antibodies (ADAs)

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    End point title
    		 Immunogenicity Assessment of Anti-drug Antibodies (ADAs) [1]
    End point description
    Confirmed cumulative incidence of anti drug antibodies development to PF-00547659. The safety analysis set included all subjects who received at least 1 dose of PF-00547659. Subjects in placebo arm were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36
    Notes
    [1] - 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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    66
    65
    68
    Units: Number of event
        Day 1 (n =46, 52, 53)
    3
    5
    1
        Week 4 (n = 55, 52, 55)
    2
    4
    2
        Week 8 (n = 44, 47, 56)
    1
    1
    1
        Week 12 (n = 47, 51, 51)
    3
    5
    1
        Week 20 (n = 4, 3, 1)
    0
    0
    0
        Week 28 (n = 8, 1, 1)
    1
    0
    0
        Week 36 (n = 6, 2, 1)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: The Pharmacokinetics (PK) of Total PF-00547659 - Area under the Concentration Time Profile from Time Zero Extrapolated to Infinite Time (AUCinf)

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    End point title
    		 The Pharmacokinetics (PK) of Total PF-00547659 - Area under the Concentration Time Profile from Time Zero Extrapolated to Infinite Time (AUCinf) [2]
    End point description
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time. All subjects who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
    Notes
    [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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    6
    8
    6
    Units: µg•hr/mL
        geometric mean (geometric coefficient of variation)
    615300 ( 63 )
    4464000 ( 28 )
    13760000 ( 49 )
    No statistical analyses for this end point

    Secondary: The Pharmacokinetics (PK) of Total PF-00547659 - Area under the Concentration Time Profile from Time Zero to Time Tau (AUCtau)

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    End point title
    		 The Pharmacokinetics (PK) of Total PF-00547659 - Area under the Concentration Time Profile from Time Zero to Time Tau (AUCtau) [3]
    End point description
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks). All subjects who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
    Notes
    [3] - 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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    7
    10
    12
    Units: µg•hr/mL
        geometric mean (geometric coefficient of variation)
    549500 ( 53 )
    4214000 ( 31 )
    10850000 ( 45 )
    No statistical analyses for this end point

    Secondary: The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)

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    End point title
    		 The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) [4]
    End point description
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration. All subjects who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
    Notes
    [4] - 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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    7
    10
    13
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    1756 ( 45 )
    10800 ( 22 )
    24100 ( 47 )
    No statistical analyses for this end point

    Secondary: The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)

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    End point title
    		 The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax) [5]
    End point description
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax. All subjects who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
    Notes
    [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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    7
    10
    13
    Units: Hours
        median (full range (min-max))
    140 (43.9 to 333)
    143 (44.9 to 171)
    165 (51.7 to 214)
    No statistical analyses for this end point

    Secondary: The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)

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    End point title
    		 The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf) [6]
    End point description
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life. All subjects who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
    Notes
    [6] - 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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    6
    8
    6
    Units: Day
        arithmetic mean (standard deviation)
    4.977 ( 2.8435 )
    8.77 ( 2.3571 )
    12.22 ( 3.8306 )
    No statistical analyses for this end point

    Secondary: The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)

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    End point title
    		 The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F) [7]
    End point description
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance. All subjects who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
    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: The 4th arm is placebo control. Hence, PK evaluations were not done.
    End point values
    		 PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    6
    8
    6
    Units: mL/hr
        geometric mean (geometric coefficient of variation)
    36.54 ( 63 )
    16.79 ( 28 )
    16.38 ( 49 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening to Week 36
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 225 mg
    Reporting group description
    		 PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 75 mg
    Reporting group description
    		 PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks.

    Reporting group title
    PF-00547659 22.5 mg
    Reporting group description
    		 PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.

    Serious adverse events
    		 Placebo PF-00547659 225 mg PF-00547659 75 mg PF-00547659 22.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 63 (9.52%)
    11 / 68 (16.18%)
    11 / 65 (16.92%)
    12 / 66 (18.18%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar infarction
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    4 / 63 (6.35%)
    4 / 68 (5.88%)
    6 / 65 (9.23%)
    5 / 66 (7.58%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 5
    1 / 6
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula of small intestine
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal stenosis
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 63 (0.00%)
    2 / 68 (2.94%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    1 / 65 (1.54%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo PF-00547659 225 mg PF-00547659 75 mg PF-00547659 22.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 63 (55.56%)
    42 / 68 (61.76%)
    32 / 65 (49.23%)
    36 / 66 (54.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 63 (9.52%)
    8 / 68 (11.76%)
    3 / 65 (4.62%)
    6 / 66 (9.09%)
         occurrences all number
    8
    9
    4
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 68 (2.94%)
    4 / 65 (6.15%)
    5 / 66 (7.58%)
         occurrences all number
    3
    2
    4
    7
    Injection site erythema
         subjects affected / exposed
    3 / 63 (4.76%)
    2 / 68 (2.94%)
    4 / 65 (6.15%)
    1 / 66 (1.52%)
         occurrences all number
    4
    3
    8
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 63 (0.00%)
    5 / 68 (7.35%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences all number
    0
    5
    2
    0
    Pyrexia
         subjects affected / exposed
    7 / 63 (11.11%)
    8 / 68 (11.76%)
    6 / 65 (9.23%)
    5 / 66 (7.58%)
         occurrences all number
    8
    9
    8
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 63 (4.76%)
    4 / 68 (5.88%)
    1 / 65 (1.54%)
    7 / 66 (10.61%)
         occurrences all number
    3
    5
    2
    8
    Crohn's disease
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 68 (1.47%)
    7 / 65 (10.77%)
    5 / 66 (7.58%)
         occurrences all number
    6
    1
    8
    5
    Diarrhoea
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
    4 / 65 (6.15%)
    1 / 66 (1.52%)
         occurrences all number
    3
    1
    4
    1
    Nausea
         subjects affected / exposed
    7 / 63 (11.11%)
    5 / 68 (7.35%)
    4 / 65 (6.15%)
    7 / 66 (10.61%)
         occurrences all number
    7
    5
    5
    7
    Proctalgia
         subjects affected / exposed
    0 / 63 (0.00%)
    1 / 68 (1.47%)
    4 / 65 (6.15%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    4
    3
    Vomiting
         subjects affected / exposed
    4 / 63 (6.35%)
    3 / 68 (4.41%)
    3 / 65 (4.62%)
    4 / 66 (6.06%)
         occurrences all number
    4
    3
    3
    5
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 68 (5.88%)
    2 / 65 (3.08%)
    3 / 66 (4.55%)
         occurrences all number
    2
    4
    3
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 63 (4.76%)
    5 / 68 (7.35%)
    6 / 65 (9.23%)
    5 / 66 (7.58%)
         occurrences all number
    3
    5
    6
    5
    Back pain
         subjects affected / exposed
    2 / 63 (3.17%)
    4 / 68 (5.88%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 63 (1.59%)
    1 / 68 (1.47%)
    2 / 65 (3.08%)
    4 / 66 (6.06%)
         occurrences all number
    1
    1
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    5 / 63 (7.94%)
    5 / 68 (7.35%)
    4 / 65 (6.15%)
    3 / 66 (4.55%)
         occurrences all number
    5
    6
    4
    3
    Urinary tract infection
         subjects affected / exposed
    5 / 63 (7.94%)
    3 / 68 (4.41%)
    1 / 65 (1.54%)
    2 / 66 (3.03%)
         occurrences all number
    6
    4
    1
    2
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 68 (0.00%)
    0 / 65 (0.00%)
    3 / 66 (4.55%)
         occurrences all number
    0
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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