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    Clinical Trial Results:
    A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Peripheral Spondyloarthritis

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2009-014567-39
    Trial protocol
    DE   FR   BE   IE   HU   ES   CZ   GR  
    Global end of trial date
    12 May 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    18 Jul 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    potential category issues

    Trial information

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    Trial identification
    Sponsor protocol code
    M10-883
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01064856
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Abbvie Deutschland GmbH & Co.KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    In-Ho Song, AbbVie, in-ho.song@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in subjects with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.
    Protection of trial subjects
    All subjects entering the study had to sign an informed consent that was explained to them and questions encouraged.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Mar 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 32
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    United States: 19
    Country: Number of subjects enrolled
    Belgium: 21
    Country: Number of subjects enrolled
    Czech Republic: 35
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Greece: 7
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Ireland: 2
    Worldwide total number of subjects
    165
    EEA total number of subjects
    105
    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)
    162
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study included a 30-day screening period.

    Period 1
    Period 1 title
    Double-blind (DB) Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Carer, Subject
    Blinding implementation details
    All subjects were centrally randomized using an Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS). All personnel with direct oversight of the conduct and management of the trial (except the Drug Supply Management Team) investigator, study site personnel, and subject remained blinded to each subject's treatment throughout the 12-week DB period. The IVRS/IWRS provided access to blinded subject treatment information in the case of medical emergency.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double-blind Placebo
    Arm description
    Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
    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
    Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

    Arm title
    Double-blind Adalimumab
    Arm description
    Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period.
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira®, ABT-D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

    Number of subjects in period 1
    Double-blind Placebo Double-blind Adalimumab
    Started
    81
    84
    Completed
    81
    82
    Not completed
    0
    2
         Adverse event
             -
             1
         Consent withdrawn by subject
             -
             1
    Period 2
    Period 2 title
    Open-label (OL) Period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double-blind Placebo / Open-label Adalimumab
    Arm description
    Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
    Arm type
    Placebo

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira®, ABT-D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

    Arm title
    Double-blind Adalimumab / Open-label Adalimumab
    Arm description
    Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira®, ABT-D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

    Number of subjects in period 2
    Double-blind Placebo / Open-label Adalimumab Double-blind Adalimumab / Open-label Adalimumab
    Started
    81
    82
    Completed
    61
    56
    Not completed
    20
    26
         Adverse event
             6
             12
         Not specified
             7
             7
         Consent withdrawn by subject
             6
             5
         Lost to follow-up
             1
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-blind Placebo
    Reporting group description
    Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.

    Reporting group title
    Double-blind Adalimumab
    Reporting group description
    Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period.

    Reporting group values
    Double-blind Placebo Double-blind Adalimumab Total
    Number of subjects
    81 84 165
    Age categorical
    Units: Subjects
        < 40 years
    50 35 85
        40 to 65 years
    29 48 77
        > 65 years
    2 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.5 ± 12.77 42.5 ± 10.79 -
    Gender categorical
    Units: Subjects
        Female
    42 48 90
        Male
    39 36 75
    Tender Joint Count (78 Joints)
    Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (no tenderness) to 78 (worst possible score/severe tenderness).
    Units: units on a scale
        arithmetic mean (standard deviation)
    13.62 ± 16.101 12.95 ± 12.79 -
    Swollen Joint Count (76 Joints)
    Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (no swelling) to 76 (worst possible score/severe swelling).
    Units: units on a scale
        arithmetic mean (standard deviation)
    7.31 ± 7.996 6.12 ± 5.581 -
    Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
    Assessment of enthesitis was performed in 7 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
    Units: units on a scale
        arithmetic mean (standard deviation)
    3.59 ± 3.398 3.13 ± 3.603 -
    Leeds Enthesitis Index
    Assessment of enthesitis was performed in 6 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (no tenderness) to 6 (worst possible score; severe tenderness).
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.42 ± 1.611 1.49 ± 1.661 -
    Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
    Assessment of enthesitis was performed in 16 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (no tenderness) to 16 (worst possible score; severe tenderness).
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.05 ± 3.785 3.83 ± 4.038 -
    Total Enthesitis Count
    Total enthesitis count in the sum of all unique, individual entheses location included in the Leeds, SPARCC, and MASES entheses indices. Scores range from 0 (no enthesitis) to 29 (most severe enthesitis).
    Units: units on a scale
        arithmetic mean (standard deviation)
    7.33 ± 6.69 6.73 ± 6.958 -
    Patient Global Assessment (PTGA) of Disease Activity
    PTGA of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms.
    Units: mm
        arithmetic mean (standard deviation)
    66.43 ± 15.864 65.24 ± 15.225 -
    PTGA – Pain
    PTGA – Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain.
    Units: units on a scale
        arithmetic mean (standard deviation)
    65.6 ± 15.897 64.3 ± 14.036 -
    Physician Global Assessment (PGA) of Disease Activity
    A VAS was to be used for the PGA of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity.
    Units: units on a scale
        arithmetic mean (standard deviation)
    57.02 ± 14.987 60.29 ± 15.537 -
    Ankylosing Spondylitis Disease Activity Score (ASDAS)
    The ASDAS is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). One subject in the Placebo arm did not have a baseline ASDAS assessment.
    Units: units on a scale
        arithmetic mean (standard deviation)
    3.06 ± 0.804 2.92 ± 0.844 -
    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    The BASDAI consisted of a VAS scale used to answer 6 questions pertaining to symptoms experienced by the subject for the past week. Each question on the BASDAI was reported in cm (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The BASDAI has a maximum value of 10.
    Units: units on a scale
        arithmetic mean (standard deviation)
    5.57 ± 1.587 5.68 ± 1.749 -
    Dactylitis Count
    Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the subjects' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no dactylitis) to 20 (worst possible score; severe dactylitis). One subject in the Adalimumab arm did not have a baseline dactylitis count.
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.65 ± 1.257 0.35 ± 0.943 -
    Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS)
    The SF-36™V2 is a 36-item generic health-related quality of life measure to assess the subject's view of their health consisting of 2 components: physical and mental. Scores range from 0 to 100. Higher scores indicate a better health state.
    Units: units on a scale
        arithmetic mean (standard deviation)
    34.48 ± 7.629 34.56 ± 7.936 -

    End points

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    End points reporting groups
    Reporting group title
    Double-blind Placebo
    Reporting group description
    Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.

    Reporting group title
    Double-blind Adalimumab
    Reporting group description
    Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period.
    Reporting group title
    Double-blind Placebo / Open-label Adalimumab
    Reporting group description
    Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.

    Reporting group title
    Double-blind Adalimumab / Open-label Adalimumab
    Reporting group description
    Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.

    Primary: Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12

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    End point title
    Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12
    End point description
    Percentage of subjects achieving the following composite response at Week 12: ≥ 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; ≥ 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA – Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and ≥ 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: percentage of subjects
    number (not applicable)
        Responder
    19.8
    39.3
        Non-responder
    80.2
    60.7
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo v Double-blind Adalimumab
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006 [1]
    Method
    Pearson's chi-square
    Confidence interval
    Notes
    [1] - Based on Pearson's chi-square test.

    Secondary: Change from Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12

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    End point title
    Change from Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12
    End point description
    A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -18.2 ± 22.93
    -32.2 ± 22.52
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo v Double-blind Adalimumab
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    ANCOVA
    Confidence interval
    Notes
    [2] - Based on an ANCOVA model adjusting for baseline with treatment as a factor.

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
    End point description
    The BASDAI was to be completed at the designated study visits. The subject was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the subject for the past week. Each question on the BASDAI was reported in cm (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The BASDAI has a maximum value of 10 and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1 ± 2.19
    -2.1 ± 2.32
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo v Double-blind Adalimumab
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.003 [3]
    Method
    ANCOVA
    Confidence interval
    Notes
    [3] - Based on an ANCOVA model adjusting for baseline with treatment as a factor.

    Secondary: Change from Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12

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    End point title
    Change from Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12
    End point description
    The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.2 ± 0.47
    -0.3 ± 0.44
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double-blind Placebo v Double-blind Adalimumab
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.051 [4]
    Method
    ANCOVA
    Confidence interval
    Notes
    [4] - Based on an ANCOVA model adjusting for baseline with treatment as a factor.

    Secondary: Change from Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12

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    End point title
    Change from Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12
    End point description
    The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the subject's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    79 [5]
    83 [6]
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.4 ± 6.65
    6.7 ± 7.85
    Notes
    [5] - subjects with non-missing values
    [6] - subjects with non-missing values
    No statistical analyses for this end point

    Secondary: Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12

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    End point title
    Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12
    End point description
    Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Subjects with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.8 ± 2.38
    -1.2 ± 2.67
    No statistical analyses for this end point

    Secondary: Change from Baseline in Leeds Enthesitis Index at Week 12

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    End point title
    Change from Baseline in Leeds Enthesitis Index at Week 12
    End point description
    Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (no tenderness) to 6 (worst possible score; severe tenderness). Subjects with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.1 ± 1.19
    -0.8 ± 1.28
    No statistical analyses for this end point

    Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12

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    End point title
    Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12
    End point description
    Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (no tenderness) to 16 (worst possible score; severe tenderness). Subjects with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.7 ± 2.21
    -1.7 ± 2.43
    No statistical analyses for this end point

    Secondary: Change from Baseline in Dactylitis at Week 12

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    End point title
    Change from Baseline in Dactylitis at Week 12
    End point description
    Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the subjects' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no dactylitis) to 20 (worst possible score; severe dactylitis). Subjects with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    83 [7]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.3 ± 0.93
    -0.2 ± 1.05
    Notes
    [7] - subjects with non-missing values for both Baseline and the post-baseline
    No statistical analyses for this end point

    Secondary: Change from Baseline in Tender Joint Count 78 (TJC78) and Swollen Joint Count 76 (SJC76) at Week 12

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    End point title
    Change from Baseline in Tender Joint Count 78 (TJC78) and Swollen Joint Count 76 (SJC76) at Week 12
    End point description
    Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC78 score of 0 (no swelling) to 78 (worst possible score). Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC76 of 0 (no swelling) to 76 (worst possible score). Subjects with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    81
    84
    Units: units on a scale
    arithmetic mean (standard deviation)
        TJC78
    -1.8 ± 8.41
    -5.9 ± 8.67
        SJC76
    -3.1 ± 5.64
    -3.6 ± 4.27
    No statistical analyses for this end point

    Secondary: Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12

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    End point title
    Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
    End point description
    The ASDAS is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Subjects with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.
    End point type
    Secondary
    End point timeframe
    Baseline (last measurement prior to first DB dose), Week 12
    End point values
    Double-blind Placebo Double-blind Adalimumab
    Number of subjects analysed
    80 [8]
    84
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.5 ± 0.9
    -1 ± 1.07
    Notes
    [8] - subjects with non-missing values for both Baseline and post-baseline visit
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (day of first study drug administration) through Week 156 plus 70 days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Double-blind Placebo
    Reporting group description
    Placebo SC injection eow up to Week 12 in the double-blind period.

    Reporting group title
    Double-blind Adalimumab
    Reporting group description
    Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period.

    Reporting group title
    Any Adalimumab
    Reporting group description
    All randomized subjects who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).

    Serious adverse events
    Double-blind Placebo Double-blind Adalimumab Any Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 84 (1.19%)
    24 / 165 (14.55%)
         number of deaths (all causes)
    0
    0
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Fibula fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Investigations
    Mycobacterium tuberculosis complex test positive
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phaeochromocytoma
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Brain stem haemorrage
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasculitis cerebral
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 84 (0.00%)
    0 / 165 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    3 / 165 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    1 / 165 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Double-blind Placebo Double-blind Adalimumab Any Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 81 (40.74%)
    30 / 84 (35.71%)
    139 / 165 (84.24%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 84 (2.38%)
    12 / 165 (7.27%)
         occurrences all number
    0
    2
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 84 (1.19%)
    14 / 165 (8.48%)
         occurrences all number
    1
    1
    17
    Influenza like illness
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    7 / 165 (4.24%)
         occurrences all number
    0
    0
    7
    Injection site reaction
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    8 / 165 (4.85%)
         occurrences all number
    0
    1
    9
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    6 / 165 (3.64%)
         occurrences all number
    0
    0
    6
    Fall
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    8 / 165 (4.85%)
         occurrences all number
    0
    0
    9
    Ligament sprain
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    6 / 165 (3.64%)
         occurrences all number
    0
    0
    6
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 84 (0.00%)
    8 / 165 (4.85%)
         occurrences all number
    2
    0
    9
    Liver function test abnormal
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    6 / 165 (3.64%)
         occurrences all number
    0
    0
    6
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 81 (1.23%)
    4 / 84 (4.76%)
    12 / 165 (7.27%)
         occurrences all number
    1
    5
    15
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 84 (2.38%)
    12 / 165 (7.27%)
         occurrences all number
    2
    2
    15
    Oropharyngeal pain
         subjects affected / exposed
    3 / 81 (3.70%)
    3 / 84 (3.57%)
    15 / 165 (9.09%)
         occurrences all number
    3
    3
    17
    Sinus congestion
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 84 (1.19%)
    5 / 165 (3.03%)
         occurrences all number
    1
    1
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 81 (3.70%)
    4 / 84 (4.76%)
    17 / 165 (10.30%)
         occurrences all number
    3
    8
    27
    Paraesthesia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    6 / 165 (3.64%)
         occurrences all number
    0
    1
    7
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 84 (1.19%)
    5 / 165 (3.03%)
         occurrences all number
    1
    1
    5
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    6 / 165 (3.64%)
         occurrences all number
    0
    1
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 81 (4.94%)
    1 / 84 (1.19%)
    15 / 165 (9.09%)
         occurrences all number
    4
    1
    15
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 84 (0.00%)
    5 / 165 (3.03%)
         occurrences all number
    1
    0
    5
    Nausea
         subjects affected / exposed
    3 / 81 (3.70%)
    2 / 84 (2.38%)
    10 / 165 (6.06%)
         occurrences all number
    4
    4
    14
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    6 / 165 (3.64%)
         occurrences all number
    0
    1
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    11 / 165 (6.67%)
         occurrences all number
    0
    1
    11
    Back pain
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    7 / 165 (4.24%)
         occurrences all number
    0
    1
    9
    Muscle spasms
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 84 (2.38%)
    9 / 165 (5.45%)
         occurrences all number
    0
    3
    13
    Neck pain
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    7 / 165 (4.24%)
         occurrences all number
    0
    0
    10
    Spondyloarthropathy
         subjects affected / exposed
    4 / 81 (4.94%)
    6 / 84 (7.14%)
    42 / 165 (25.45%)
         occurrences all number
    4
    6
    73
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 84 (1.19%)
    23 / 165 (13.94%)
         occurrences all number
    2
    1
    29
    Conjunctivitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    6 / 165 (3.64%)
         occurrences all number
    0
    1
    8
    Cystitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    7 / 165 (4.24%)
         occurrences all number
    0
    1
    9
    Gastroenteritis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    10 / 165 (6.06%)
         occurrences all number
    0
    1
    15
    Gastroenteritis viral
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    5 / 165 (3.03%)
         occurrences all number
    0
    1
    5
    Influenza
         subjects affected / exposed
    1 / 81 (1.23%)
    3 / 84 (3.57%)
    8 / 165 (4.85%)
         occurrences all number
    1
    3
    8
    Nasopharyngitis
         subjects affected / exposed
    11 / 81 (13.58%)
    4 / 84 (4.76%)
    51 / 165 (30.91%)
         occurrences all number
    11
    4
    75
    Oral herpes
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    5 / 165 (3.03%)
         occurrences all number
    0
    1
    6
    Pharyngitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 84 (0.00%)
    12 / 165 (7.27%)
         occurrences all number
    0
    0
    13
    Rhinitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    13 / 165 (7.88%)
         occurrences all number
    0
    1
    17
    Sinusitis
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 84 (1.19%)
    15 / 165 (9.09%)
         occurrences all number
    1
    1
    26
    Tonsillitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 84 (1.19%)
    8 / 165 (4.85%)
         occurrences all number
    0
    1
    11
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 81 (4.94%)
    4 / 84 (4.76%)
    30 / 165 (18.18%)
         occurrences all number
    4
    4
    69
    Urinary tract infection
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 84 (0.00%)
    7 / 165 (4.24%)
         occurrences all number
    2
    0
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Nov 2009
    ● Updated Table 1 Efficacy and Safety Measurements and Flow Chart to add high-sensitivity C-reactive protein to table for consistency within the protocol. Revised footnote "e" to increase the acceptable time frame for anteroposterior pelvic x-ray, from 90 days to 180 days. ● Updated Study Procedures to increase window for prior AP pelvic x-ray from 3 months (90 days) to 6 months (180 days). ● Updated Table 2 Clinical Laboratory Tests to clarify the time points of when tests were to be performed. Moved human chorionic gonadotropin to proper laboratory category. ● Updated Protocol Appendix B, List of Protocol Signatories. ● Corrected minor typographical errors.
    10 Dec 2009
    ● Updated exclusion criteria to add criterion to clarify maximum dose, stability, and washout requirements for corticosteroids. ● Updated exclusion criteria to add criterion to exclude subjects with diagnosis and current symptoms of fibromyalgia.
    21 Apr 2010
    ● Updated the title page to correct European Union Sponsor address. ● Updated Selection of Study Population to add "non-AS" to selection of study population for consistency. ● Updated inclusion criteria to modify criterion to specify severity of disease as agreed upon with the Food and Drug Administration (FDA). ● Updated exclusion criteria to revise criterion to remove age restriction for early onset arthritis. ● Updated Table 1 Efficacy and Safety Measurement and Flow Chart to remove duplicate table note and corrected references within Table 1. Added Week 52 urinalysis and updated corresponding table note. ● Updated Study Procedures to clarify acceptable alternative methods for the purified protein derivative skin test for tuberculosis screening and to add the local requirements for the Czech Republic. ● Updated Health Outcomes Questionnaires to add tenderness and swelling assessment for dactylitis. ● Updated Discussion of Study Design and Choice of Control Groups to add the words "non-AS" and "active" to clarify subject population. ● Updated Suitability of Subject Population to add "non-AS" to selection of study population for consistency. ● Added applicable reference to Protocol Appendix I. PGA of Disease Activity: VAS. ● Revised Protocol Appendix Q. Subject Dosing Sheets – Adalimumab and instruction text as per updated standard protocol text. ● Added Protocol Appendix V. Dactylitis Assessment to include clarification on how to capture presence of swelling and tenderness for dactylitis. ● Updated Table 2 Clinical Laboratory Tests to add leukocytes and nitrites to remain consistent with the text.
    22 Nov 2010
    ● Updated Study Procedures to add text to footnote on Table 2. Clinical Laboratory Tests regarding an additional confirmatory human leukocyte antigen-B27 test if the initial test result was reported as equivocal.
    22 Mar 2012
    ● Extended the study for 1 additional year (from 104 to 156 weeks). ● Updated Overall Study Design and Plan as well as the Table 1 Study Activities table to reflect 144 weeks of open-label treatment. ● Updated Table 1 Study Activities for TB testing to include acceptability of QuantiFERON-TB Gold test and yearly testing of subjects that were PPD negative at Screening. ● Editorial edits to comply with the current protocol template and Humira standards.
    27 Jun 2013
    ● Update sections of the protocol to incorporate AbbVie's participation in an FDA-requested tumor necrosis factor (TNF) inhibitor class wide exploration of the rare appearance of malignancy in patients who are 30 years of age or younger at the time of diagnosis. ● Incorporate Administrative Change 2 into this protocol to update the Sponsor Name Change throughout the document. ● Editorial changes to reflect the current protocol template and safety standards.

    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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