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    Clinical Trial Results:
    A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa - PIONEER I

    Summary
    EudraCT number
    		 2011-003400-20
    Trial protocol
    		 DE   CZ   HU  
    Global end of trial date
    16 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    01 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M11-313
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01468207
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    David Williams MD, AbbVie, david.a.williams@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000366-PIP04-12
    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
    16 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 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
    Australia: 19
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    United States: 155
    Country: Number of subjects enrolled
    Czech Republic: 31
    Country: Number of subjects enrolled
    Germany: 55
    Country: Number of subjects enrolled
    Hungary: 13
    Worldwide total number of subjects
    307
    EEA total number of subjects
    99
    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)
    304
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 48 investigative sites in Australia, Canada, Czech Republic, Germany, Hungary, and the United States.

    Pre-assignment
    Screening details
    		 Subjects ≥ 18 years of age with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.

    Period 1
    Period 1 title
    Treatment Period 1
    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
    		 Placebo for 12 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
    Placebo pre-filled syringe, administered by subcutaneous injection

    Arm title
    		 Adalimumab Every Week (EW)
    Arm description
    		 Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Number of subjects in period 1
    		Placebo Adalimumab Every Week (EW)
    Started
    154
    153
    Received study drug
    152
    153
    Completed
    145
    145
    Not completed
    9
    8
         Consent withdrawn by subject
    5
    4
         Other, not specified
    -
    2
         Adverse event
    1
    -
         Lost to follow-up
    2
    1
         Protocol deviation
    1
    1
    Period 2
    Period 2 title
    Treatment Period 2
    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/Adalimumab Every Week (EW)
    Arm description
    		 Subjects randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    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
    Placebo pre-filled syringe, administered by subcutaneous injection

    Arm title
    		 Adalimumab Every Week (EW)/Placebo
    Arm description
    		 Subjects randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 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
    Placebo pre-filled syringe, administered by subcutaneous injection

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Arm title
    		 Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)
    Arm description
    		 Subjects randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Arm title
    		 Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
    Arm description
    		 Subjects randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Number of subjects in period 2
    		Placebo/Adalimumab Every Week (EW) Adalimumab Every Week (EW)/Placebo Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
    Started
    145
    49
    48
    48
    Completed
    93
    22
    27
    28
    Not completed
    52
    27
    21
    20
         Consent withdrawn by subject
    5
    -
    -
    2
         Other, not specified
    5
    1
    1
    2
         Adverse event
    6
    1
    2
    1
         Loss or absence of response (per protocol)
    30
    23
    18
    13
         Lost to follow-up
    5
    1
    -
    -
         Lack of efficacy
    1
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for 12 weeks.

    Reporting group title
    Adalimumab Every Week (EW)
    Reporting group description
    		 Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).

    Reporting group values
    		 Placebo Adalimumab Every Week (EW) Total
    Number of subjects
    		 154 153 307
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.8 ( 11.33 ) 36.2 ( 10.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 105 91 196
        Male
    		 49 62 111

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for 12 weeks.

    Reporting group title
    Adalimumab Every Week (EW)
    Reporting group description
    		 Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
    Reporting group title
    Placebo/Adalimumab Every Week (EW)
    Reporting group description
    		 Subjects randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).

    Reporting group title
    Adalimumab Every Week (EW)/Placebo
    Reporting group description
    		 Subjects randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Reporting group title
    Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)
    Reporting group description
    		 Subjects randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).

    Reporting group title
    Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
    Reporting group description
    		 Subjects randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Subject analysis set title
    Placebo - Baseline Hurley Stage II
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.

    Subject analysis set title
    Placebo - Baseline Hurley Stage III
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.

    Subject analysis set title
    Adalimumab Every Week (EW) - Baseline Hurley Stage II
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).

    Subject analysis set title
    Adalimumab Every Week (ew) - Baseline Hurley Stage III
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).

    Subject analysis set title
    Placebo - Baseline NRS at Worst ≥ 3
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.

    Subject analysis set title
    Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).

    Primary: Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

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    End point title
    		 Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
    End point description
    Hidradenitis Suppurativa Clinical Response (HiSCR) was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all subjects and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A subject with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A subject with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Subjects with missing data were considered non-responders.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) up to Week 12
    End point values
    		 Placebo Adalimumab Every Week (EW) Placebo - Baseline Hurley Stage II Placebo - Baseline Hurley Stage III Adalimumab Every Week (EW) - Baseline Hurley Stage II Adalimumab Every Week (ew) - Baseline Hurley Stage III
    Number of subjects analysed
    154
    153
    84
    70
    83
    70
    Units: percentage of subjects
        number (not applicable)
    26
    41.8
    29.8
    21.4
    44.6
    38.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The p-value was calculated from the Cochran-Mantel-Haenszel test adjusted for baseline Hurley Stage.
    Comparison groups
    Placebo v Adalimumab Every Week (EW)
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted mean difference
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.3
         upper limit
    		 26.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The p-value was calculated based on chi-square test.
    Comparison groups
    Placebo - Baseline Hurley Stage II v Adalimumab Every Week (EW) - Baseline Hurley Stage II
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.048
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 29.3
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The p-value was calculated based on chi-square test.
    Comparison groups
    Adalimumab Every Week (ew) - Baseline Hurley Stage III v Placebo - Baseline Hurley Stage III
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.027
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 32.1

    Secondary: Percentage of Subjects with Baseline Hurley Stage II who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12

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    End point title
    		 Percentage of Subjects with Baseline Hurley Stage II who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
    End point description
    The percentage of subjects with AN counts lowered to 0, 1, or 2 at Week 12 among subjects with Hurley Stage II at Baseline. Non-responder imputation (NRI): Subjects with missing data were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) up to Week 12
    End point values
    		 Placebo - Baseline Hurley Stage II Adalimumab Every Week (EW) - Baseline Hurley Stage II
    Number of subjects analysed
    84
    83
    Units: percentage of subjects
        number (not applicable)
    28.6
    28.9
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses. The p-value for the AN 0/1/2 counts end point was calculated from the Chi Squared test.
    Comparison groups
    Placebo - Baseline Hurley Stage II v Adalimumab Every Week (EW) - Baseline Hurley Stage II
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.961
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.4
         upper limit
    		 14.1

    Secondary: Percentage of Subjects Achieving At Least 30% Reduction and At Least 1 Unit Reduction from Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Subjects with Baseline Skin Pain NRS ≥ 3

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    End point title
    		 Percentage of Subjects Achieving At Least 30% Reduction and At Least 1 Unit Reduction from Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Subjects with Baseline Skin Pain NRS ≥ 3
    End point description
    The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by subjects before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of subjects who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among subjects with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. Non-responder imputation (NRI): Subjects with missing data were considered non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) up to Week 12
    End point values
    		 Placebo - Baseline NRS at Worst ≥ 3 Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
    Number of subjects analysed
    109
    122
    Units: percentage of subjects
        number (not applicable)
    24.8
    27.9
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses. The p-value for the NRS30 end point was calculated from the Cochran-Mantel-Haenszel test adjusted for baseline Hurley Stage.
    Comparison groups
    Placebo - Baseline NRS at Worst ≥ 3 v Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.628
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted mean difference
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 14.2

    Secondary: Change from Baseline to Week 12 in Modified Sartorius Score

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    End point title
    		 Change from Baseline to Week 12 in Modified Sartorius Score
    End point description
    The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Placebo Adalimumab Every Week (EW)
    Number of subjects analysed
    151
    153
    Units: units on a scale
        least squares mean (standard error)
    -15.7 ( 4 )
    -24.4 ( 3.97 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.The p-value for the modified Sartorius score end point was calculated from ANCOVA with stratum, baseline, and treatment as covariates.
    Comparison groups
    Placebo v Adalimumab Every Week (EW)
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.124
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.7
         upper limit
    		 2.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from first dose of study drug until 70 days following last dose of study drug (46 weeks); SAEs were collected from the time that informed consent was obtained (up to 50 weeks).
    Adverse event reporting additional description
    AEs with onset in Period 1 were collected from first dose of study drug until prior to the first dose in Period 2, or up to 70 days following last dose of study drug if the subject discontinued during Period 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo (Period 1)
    Reporting group description
    		 Placebo for 12 weeks

    Reporting group title
    Adalimumab EW (Period 1)
    Reporting group description
    		 Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).

    Reporting group title
    Placebo/Adalimumab EW (Period 2)
    Reporting group description
    		 Subjects randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks).

    Reporting group title
    Adalimumab EW/Placebo (Period 2)
    Reporting group description
    		 Subjects randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Reporting group title
    Adalimumab EW/ Adalimumab EOW (Period 2)
    Reporting group description
    		 Subjects randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).

    Reporting group title
    Adalimumab EW/Adalimumab EW (Period 2)
    Reporting group description
    		 Subjects randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

    Serious adverse events
    		 Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Adalimumab EW (Period 2) Adalimumab EW/Placebo (Period 2) Adalimumab EW/ Adalimumab EOW (Period 2) Adalimumab EW/Adalimumab EW (Period 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 152 (3.29%)
    3 / 153 (1.96%)
    5 / 145 (3.45%)
    2 / 49 (4.08%)
    3 / 48 (6.25%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Investigations
    Hepatitis A antibody positive
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Liver function test abnormal
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Effusion
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    3 / 152 (1.97%)
    1 / 153 (0.65%)
    2 / 145 (1.38%)
    2 / 49 (4.08%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc calcification
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Tendonitis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Adalimumab EW (Period 2) Adalimumab EW/Placebo (Period 2) Adalimumab EW/ Adalimumab EOW (Period 2) Adalimumab EW/Adalimumab EW (Period 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 152 (53.29%)
    64 / 153 (41.83%)
    68 / 145 (46.90%)
    30 / 49 (61.22%)
    24 / 48 (50.00%)
    28 / 48 (58.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 152 (1.97%)
    1 / 153 (0.65%)
    2 / 145 (1.38%)
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    2
    2
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 152 (2.63%)
    3 / 153 (1.96%)
    2 / 145 (1.38%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    6
    3
    2
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    3 / 152 (1.97%)
    1 / 153 (0.65%)
    2 / 145 (1.38%)
    0 / 49 (0.00%)
    3 / 48 (6.25%)
    2 / 48 (4.17%)
         occurrences all number
    4
    1
    2
    0
    3
    2
    Chills
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Injection site bruising
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    6 / 145 (4.14%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    16
    0
    0
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    3 / 145 (2.07%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    13
    0
    0
    1
    Local swelling
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Xerosis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 152 (2.63%)
    2 / 153 (1.31%)
    3 / 145 (2.07%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    4
    3
    3
    1
    0
    0
    Asthma
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    3 / 152 (1.97%)
    2 / 153 (1.31%)
    2 / 145 (1.38%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
         occurrences all number
    3
    2
    3
    0
    1
    2
    Respiratory tract congestion
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 152 (0.00%)
    3 / 153 (1.96%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    3
    2
    1
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
         occurrences all number
    1
    1
    1
    0
    1
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    2 / 145 (1.38%)
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    3 / 152 (1.97%)
    3 / 153 (1.96%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    3
    3
    2
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 152 (0.00%)
    2 / 153 (1.31%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Weight increased
         subjects affected / exposed
    3 / 152 (1.97%)
    3 / 153 (1.96%)
    2 / 145 (1.38%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    3
    3
    2
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 153 (0.00%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Skin injury
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 152 (9.87%)
    14 / 153 (9.15%)
    9 / 145 (6.21%)
    4 / 49 (8.16%)
    3 / 48 (6.25%)
    2 / 48 (4.17%)
         occurrences all number
    18
    19
    14
    9
    3
    7
    Dizziness
         subjects affected / exposed
    2 / 152 (1.32%)
    4 / 153 (2.61%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
         occurrences all number
    2
    4
    1
    1
    2
    0
    Lethargy
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Nerve compression
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Sinus headache
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    1
    1
    1
    1
    0
    2
    Leukocytosis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    Neutrophilia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eyelid oedema
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 152 (2.63%)
    3 / 153 (1.96%)
    6 / 145 (4.14%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    4
    3
    6
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 152 (1.97%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    3
    1
    2
    2
    0
    0
    Constipation
         subjects affected / exposed
    2 / 152 (1.32%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    1
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 152 (1.32%)
    3 / 153 (1.96%)
    3 / 145 (2.07%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    3
    3
    1
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Lip swelling
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 152 (1.32%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    1
    1
    1
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    2
    0
    3
    0
    Hidradenitis
         subjects affected / exposed
    17 / 152 (11.18%)
    13 / 153 (8.50%)
    14 / 145 (9.66%)
    8 / 49 (16.33%)
    7 / 48 (14.58%)
    2 / 48 (4.17%)
         occurrences all number
    23
    15
    14
    8
    7
    2
    Acne cystic
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Dermal cyst
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 153 (0.00%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    Dermatitis papillaris capillitii
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    Eczema
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Intertrigo
         subjects affected / exposed
    2 / 152 (1.32%)
    1 / 153 (0.65%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    2
    1
    1
    2
    0
    2
    Keloid scar
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 152 (0.00%)
    3 / 153 (1.96%)
    1 / 145 (0.69%)
    3 / 49 (6.12%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
         occurrences all number
    0
    3
    1
    3
    1
    1
    Back pain
         subjects affected / exposed
    4 / 152 (2.63%)
    3 / 153 (1.96%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    4
    3
    1
    1
    0
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 152 (0.66%)
    2 / 153 (1.31%)
    3 / 145 (2.07%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    16 / 152 (10.53%)
    9 / 153 (5.88%)
    11 / 145 (7.59%)
    9 / 49 (18.37%)
    1 / 48 (2.08%)
    3 / 48 (6.25%)
         occurrences all number
    16
    9
    12
    15
    2
    3
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 152 (2.63%)
    5 / 153 (3.27%)
    5 / 145 (3.45%)
    2 / 49 (4.08%)
    3 / 48 (6.25%)
    4 / 48 (8.33%)
         occurrences all number
    4
    5
    6
    2
    4
    4
    Urinary tract infection
         subjects affected / exposed
    3 / 152 (1.97%)
    5 / 153 (3.27%)
    4 / 145 (2.76%)
    1 / 49 (2.04%)
    2 / 48 (4.17%)
    2 / 48 (4.17%)
         occurrences all number
    3
    5
    4
    1
    3
    3
    Body tinea
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 153 (0.00%)
    3 / 145 (2.07%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    3
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    2 / 152 (1.32%)
    2 / 153 (1.31%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    Cytolytic vaginosis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    2 / 145 (1.38%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
         occurrences all number
    1
    0
    2
    0
    2
    2
    Impetigo
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    3 / 152 (1.97%)
    2 / 153 (1.31%)
    3 / 145 (2.07%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    3
    2
    4
    0
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    0
    1
    1
    0
    Measles
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    2
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 152 (0.66%)
    3 / 153 (1.96%)
    4 / 145 (2.76%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    1
    3
    4
    1
    0
    2
    Skin candida
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 153 (0.65%)
    2 / 145 (1.38%)
    1 / 49 (2.04%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    2
    1
    1
    0
    Tracheitis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 153 (0.00%)
    0 / 145 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    1 / 145 (0.69%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2012
    Added lesion count assessments at unscheduled visits after Week 12; added waist circumference measurements to assessments; clarified TB testing at screening; revised anti-TB therapy to a minimum of 4 weeks completed prior to starting TNF inhibitors; provided a process of HIV antibody testing where required by country regulatory authorities; added collection of NRS pain and analgesic use using an electronic device; added representative lesion assessments at premature discontinuation visit if the visit occurred prior to Week 12; for the analysis of proportion of subjects achieving at least 30% reduction at least 1 unity reduction from baseline NRS30 - at worst at Week 12, increase baseline requirement from baseline NRS ≥1 to ≥3; classified methods of handling potential confounding effect on pain assessment when medications for HS or pain were used.
    07 Aug 2013
    Added safety monitoring language per AbbVie participation in US FDA-requested TNF inhibitor class wide exploration of the rare appearance of malignancy in patients 30 years of age or younger; provided more details to the risks and benefits of participation; added recently approved biologic therapies as prohibited therapies; clarified that antibiotic rescue therapy dosing regimen must remain stable during the study; added change and percent change from baseline in CRP; added blood samples for biologic marker analysis at Week 36 (or premature discontinuation); replaced pregnancy forms and the pregnancy registry with EDC system entry for pregnancy determination.

    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
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