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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 II

    Summary
    EudraCT number
    2011-003406-24
    Trial protocol
    SE   GR   DK   NL  
    Global end of trial date
    07 Jul 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
    M11-810
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01468233
    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
    Martin Okun MD, AbbVie, martin.okun@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
    07 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 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
    28 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 51
    Country: Number of subjects enrolled
    Canada: 29
    Country: Number of subjects enrolled
    Switzerland: 18
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    United States: 100
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Denmark: 17
    Country: Number of subjects enrolled
    France: 45
    Country: Number of subjects enrolled
    Greece: 45
    Worldwide total number of subjects
    326
    EEA total number of subjects
    126
    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)
    322
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled at 53 investigative sites in Australia, Canada, Denmark, Netherlands, Sweden, Switzerland, Turkey, Greece, France 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
    163
    163
    Completed
    151
    155
    Not completed
    12
    8
         Other, not specified
             1
             1
         Adverse event
             5
             3
         Consent withdrawn by subject
             3
             4
         Lost to follow-up
             3
             -
    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/Placebo
    Arm description
    Subjects randomized to receive placebo in Period 1 received placebo every week 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

    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 40 mg adalimumab 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/Placebo Adalimumab Every Week (EW)/Placebo Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
    Started
    151
    51
    53
    51
    Completed
    40
    23
    25
    28
    Not completed
    111
    28
    28
    23
         Other, not specified
             3
             -
             1
             -
         Adverse event
             3
             -
             2
             1
         Lack of efficacy
             9
             2
             -
             1
         Loss or absence of response (per protocol)
             84
             25
             22
             20
         Consent withdrawn by subject
             9
             1
             1
             1
         Lost to follow-up
             3
             -
             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
    163 163 326
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.1 ± 12.18 34.9 ± 9.96 -
    Gender categorical
    Units: Subjects
        Female
    113 108 221
        Male
    50 55 105

    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/Placebo
    Reporting group description
    Subjects randomized to receive placebo in Period 1 received placebo every week from Week 12 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 40 mg adalimumab 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
    163
    163
    87
    76
    85
    78
    Units: percentage of subjects
        number (not applicable)
    27.6
    58.9
    36.8
    17.1
    62.4
    55.1
    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 and for baseline antibiotic use.
    Comparison groups
    Placebo v Adalimumab Every Week (EW)
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted mean difference
    Point estimate
    31.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.7
         upper limit
    42.2
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    The p-value was calculated based on the Cochran-Mantel-Haenszel test adjusted for baseline antibiotic use (Y/N).
    Comparison groups
    Placebo - Baseline Hurley Stage II v Adalimumab Every Week (EW) - Baseline Hurley Stage II
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted mean difference
    Point estimate
    25.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.5
         upper limit
    40.5
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    The p-value was calculated based on the Cochran-Mantel-Haenszel test adjusted for baseline antibiotic use (Y/N).
    Comparison groups
    Placebo - Baseline Hurley Stage III v Adalimumab Every Week (EW) - Baseline Hurley Stage III
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted mean difference
    Point estimate
    38.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.8
         upper limit
    53.3

    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 nonresponders.
    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
    87
    85
    Units: percentage of subjects
        number (not applicable)
    32.2
    51.8
    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 Cochran-Mantel-Haenszel test adjusted for baseline antibiotics use (Y/N).
    Comparison groups
    Placebo - Baseline Hurley Stage II v Adalimumab Every Week (EW) - Baseline Hurley Stage II
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.01
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted mean difference
    Point estimate
    19.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.7
         upper limit
    34.2

    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
    111
    105
    Units: percentage of subjects
        number (not applicable)
    20.7
    45.7
    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 and antibiotics use (Y/N).
    Comparison groups
    Placebo - Baseline NRS at Worst ≥ 3 v Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted mean difference
    Point estimate
    25.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.7
         upper limit
    37.6

    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
    162
    163
    Units: units on a scale
        least squares mean (standard error)
    -9.5 ± 3.84
    -28.9 ± 3.85
    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 Hurley Stage and antibiotics use), baseline value, and treatment as covariates.
    Comparison groups
    Placebo v Adalimumab Every Week (EW)
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS mean difference
    Point estimate
    -19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.6
         upper limit
    -10.1

    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 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/Placebo (Period 2)
    Reporting group description
    Subjects randomized to receive placebo in Period 1 received placebo ew from Week 12 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 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 ew in Period 1 were re-randomized to receive 40 mg adalimumab 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 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/Placebo (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
    6 / 163 (3.68%)
    3 / 163 (1.84%)
    7 / 151 (4.64%)
    0 / 51 (0.00%)
    2 / 53 (3.77%)
    2 / 51 (3.92%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Social circumstances
    Sexual abuse
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 163 (0.61%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Depression
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Tendon rupture
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 163 (0.61%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Investigations
    International normalised ratio increased
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (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
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (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 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Lymphadenitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (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
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Presyncope
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 163 (0.61%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Renal colic
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 163 (0.61%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Viral infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Appendicitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Clostridium difficile infection
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (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
    Pneumonia
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Placebo (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
    77 / 163 (47.24%)
    66 / 163 (40.49%)
    48 / 151 (31.79%)
    27 / 51 (52.94%)
    25 / 53 (47.17%)
    21 / 51 (41.18%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 163 (0.61%)
    7 / 163 (4.29%)
    1 / 151 (0.66%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    10
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    21 / 163 (12.88%)
    21 / 163 (12.88%)
    4 / 151 (2.65%)
    4 / 51 (7.84%)
    3 / 53 (5.66%)
    5 / 51 (9.80%)
         occurrences all number
    29
    30
    5
    4
    5
    5
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    2 / 151 (1.32%)
    2 / 51 (3.92%)
    1 / 53 (1.89%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    3
    2
    1
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 163 (3.68%)
    0 / 163 (0.00%)
    2 / 151 (1.32%)
    1 / 51 (1.96%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    7
    0
    2
    1
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 163 (1.23%)
    5 / 163 (3.07%)
    0 / 151 (0.00%)
    1 / 51 (1.96%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    2
    6
    0
    1
    0
    1
    Injection site pain
         subjects affected / exposed
    5 / 163 (3.07%)
    6 / 163 (3.68%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    6
    6
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 163 (0.61%)
    2 / 151 (1.32%)
    1 / 51 (1.96%)
    2 / 53 (3.77%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    3
    1
    2
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 163 (2.45%)
    1 / 163 (0.61%)
    2 / 151 (1.32%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 163 (2.45%)
    9 / 163 (5.52%)
    2 / 151 (1.32%)
    1 / 51 (1.96%)
    4 / 53 (7.55%)
    1 / 51 (1.96%)
         occurrences all number
    4
    9
    2
    1
    4
    1
    Nausea
         subjects affected / exposed
    5 / 163 (3.07%)
    7 / 163 (4.29%)
    0 / 151 (0.00%)
    1 / 51 (1.96%)
    1 / 53 (1.89%)
    1 / 51 (1.96%)
         occurrences all number
    6
    7
    0
    1
    1
    1
    Toothache
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 163 (1.23%)
    3 / 151 (1.99%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    2
    3
    3
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 163 (1.23%)
    4 / 163 (2.45%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    2 / 53 (3.77%)
    0 / 51 (0.00%)
         occurrences all number
    2
    4
    0
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    19 / 163 (11.66%)
    7 / 163 (4.29%)
    13 / 151 (8.61%)
    10 / 51 (19.61%)
    8 / 53 (15.09%)
    3 / 51 (5.88%)
         occurrences all number
    21
    8
    15
    12
    9
    4
    Dermatitis contact
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 163 (0.00%)
    3 / 151 (1.99%)
    2 / 51 (3.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    3
    2
    0
    0
    Erythema
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 163 (0.61%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    2 / 53 (3.77%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 163 (1.84%)
    4 / 151 (2.65%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
    2 / 51 (3.92%)
         occurrences all number
    3
    3
    4
    0
    1
    2
    Muscle spasms
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 163 (1.23%)
    1 / 151 (0.66%)
    2 / 51 (3.92%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    2
    1
    2
    0
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    2 / 53 (3.77%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    1 / 51 (1.96%)
    2 / 53 (3.77%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 163 (0.00%)
    4 / 163 (2.45%)
    0 / 151 (0.00%)
    1 / 51 (1.96%)
    0 / 53 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    4
    0
    1
    0
    2
    Gastroenteritis
         subjects affected / exposed
    3 / 163 (1.84%)
    5 / 163 (3.07%)
    7 / 151 (4.64%)
    1 / 51 (1.96%)
    2 / 53 (3.77%)
    1 / 51 (1.96%)
         occurrences all number
    3
    6
    7
    1
    3
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    2 / 53 (3.77%)
    3 / 51 (5.88%)
         occurrences all number
    1
    0
    0
    0
    2
    3
    Influenza
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 163 (1.84%)
    3 / 151 (1.99%)
    2 / 51 (3.92%)
    0 / 53 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    3
    3
    3
    3
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 163 (5.52%)
    8 / 163 (4.91%)
    13 / 151 (8.61%)
    5 / 51 (9.80%)
    4 / 53 (7.55%)
    1 / 51 (1.96%)
         occurrences all number
    9
    9
    17
    7
    4
    1
    Urinary tract infection
         subjects affected / exposed
    5 / 163 (3.07%)
    1 / 163 (0.61%)
    3 / 151 (1.99%)
    1 / 51 (1.96%)
    1 / 53 (1.89%)
    0 / 51 (0.00%)
         occurrences all number
    5
    1
    3
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    4 / 163 (2.45%)
    2 / 163 (1.23%)
    2 / 151 (1.32%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    5
    2
    2
    6
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    10 / 163 (6.13%)
    9 / 163 (5.52%)
    5 / 151 (3.31%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
    3 / 51 (5.88%)
         occurrences all number
    11
    11
    6
    1
    6
    4
    Pharyngitis
         subjects affected / exposed
    0 / 163 (0.00%)
    3 / 163 (1.84%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    2 / 53 (3.77%)
    0 / 51 (0.00%)
         occurrences all number
    0
    3
    0
    0
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 163 (0.00%)
    0 / 151 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    0
    0
    0
    0
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2012
    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; 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.
    12 Apr 2012
    Added lesion count assessments at unscheduled visits after Week 12; added waist circumference measurements to assessments; 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.
    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; added blood samples for biologic marker analysis at Week 36 (or premature discontinuation); added change and percent change from baseline in CRP; 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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