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    Clinical Trial Results:
    Whole-body MRI, MRI of sacroiliac joints and spine and circulating biomarkers in patients with spondyloarthritis treated with adalimumab (ASIM)

    Summary
    EudraCT number
    		 2009-014348-12
    Trial protocol
    		 DK  
    Global end of trial date
    18 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2017
    First version publication date
    12 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ASIM (IMM 08-0061)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01029847
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Center for Rheumatology and Spine Diseases, Rigshospitalet
    Sponsor organisation address
    Valdemar Hansens Vej 17, Glostrup, Denmark, DK-2600
    Public contact
    Mikkel Østergaard, Center for Rheumatology and Spine Diseases, Rigshospitalet, mo@dadlnet.dk
    Scientific contact
    Mikkel Østergaard, Center for Rheumatology and Spine Diseases, Rigshospitalet, mo@dadlnet.dk
    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
    27 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of adalimumab on disease manifestations in axial and peripheral joints and entheses in patients with spondyloarthritis as assessed by whole-body MRI.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 50
    Number of subjects completed
    		 49

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Administrative error: 1
    Period 1
    Period 1 title
    Part 1 - baseline to week 6
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab group
    Arm description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg every other week

    Arm title
    		 Placebo group
    Arm description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of inactive fluid every other week

    Number of subjects in period 1 [1]
    		Adalimumab group Placebo group
    Started
    25
    24
    Completed
    22
    23
    Not completed
    3
    1
         Physician decision
    1
    -
         Adverse event, non-fatal
    1
    -
         Non-compliance
    1
    -
         Family overloaded
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The group allocation was not known for one patient due to an administrative error. This patient has been excluded from all analyses.
    Period 2
    Period 2 title
    Part 2 - week 6 to week 24
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab group
    Arm description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg every other week

    Arm title
    		 Placebo group
    Arm description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg every other week

    Number of subjects in period 2
    		Adalimumab group Placebo group
    Started
    22
    23
    Completed
    22
    20
    Not completed
    0
    3
         Adverse event, non-fatal
    -
    1
         Administrative error
    -
    1
         Lack of efficacy
    -
    1
    Period 3
    Period 3 title
    Part 3 - week 24 to week 48
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab group
    Arm description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg every other week

    Arm title
    		 Placebo group
    Arm description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg every other week

    Number of subjects in period 3
    		Adalimumab group Placebo group
    Started
    22
    20
    Completed
    20
    19
    Not completed
    2
    1
         Adverse event, non-fatal
    1
    1
         Non-compliance
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab group
    Reporting group description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.

    Reporting group values
    		 Adalimumab group Placebo group Total
    Number of subjects
    		 25 24 49
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.9 ( 10.8 ) 35.1 ( 7.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 14 24
        Male
    		 15 10 25
    Bath Ankylosing Spondylitits Disease Activity Index
    Units: Questionnaire based score from 0 to 10
        arithmetic mean (standard deviation)
    		 6.3 ( 1.2 ) 6.4 ( 1.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab group
    Reporting group description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Reporting group title
    Adalimumab group
    Reporting group description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.
    Reporting group title
    Adalimumab group
    Reporting group description
    		 Adalimumab from baseline to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.

    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo from baseline to week 6 followed by Adalimumab from week 6 to week 24. Clinical responders at week 24 continued subcutaneous injections of 40 mg adalimumab eow; clinical non-responders at week 24 were allowed to be treated with other drugs at the discretion of the investigator following local treatment guidelines.

    Primary: Improvement in Bath Ankylosing Spondylitis Disease Activity Index of 50% or an absolute improvement of 2.0 at week 24

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    End point title
    		 Improvement in Bath Ankylosing Spondylitis Disease Activity Index of 50% or an absolute improvement of 2.0 at week 24
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Adalimumab group Placebo group
    Number of subjects analysed
    25
    24
    Units: patients
    18
    14
    Statistical analysis title
    		 BASDAI 50% or 2.0 response at week 24
    Statistical analysis description
    Clinical responders as assessed by improvement in Bath Ankylosing Spondylitis Disease Activity Index of 50% or an absolute improvement of 2.0 at week 24.
    Comparison groups
    Adalimumab group v Placebo group
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.38
    Method
    		 Fisher exact
    Confidence interval

    Post-hoc: Difference between Adalimumab group and Placebo group in change in Bath Ankylosing Spondylitis Disease Activity Index from baseline to week 6

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    End point title
    		 Difference between Adalimumab group and Placebo group in change in Bath Ankylosing Spondylitis Disease Activity Index from baseline to week 6
    End point description
    End point type
    Post-hoc
    End point timeframe
    Week 6
    End point values
    		 Adalimumab group Placebo group
    Number of subjects analysed
    25
    24
    Units: Questionnaire based score from 0 to 10
        arithmetic mean (standard deviation)
    -2.1 ( 2.2 )
    -0.6 ( 1.8 )
    Statistical analysis title
    		 Change in BASDAI from baseline to week 6
    Statistical analysis description
    Difference between Adalimumab group and Placebo group in change in Bath Ankylosing Spondylitis Disease Activity Index from baseline to week 6.
    Comparison groups
    Adalimumab group v Placebo group
    Number of subjects included in analysis
    49
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.026
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events were collected from baseline and up to the final visit (Week 48).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Part 1 - Adalimumab group
    Reporting group description
    		 -

    Reporting group title
    Part 1 - Placebo group
    Reporting group description
    		 -

    Reporting group title
    Part 2 - Adalimumab
    Reporting group description
    		 -

    Reporting group title
    Part 3 - Adalimumab
    Reporting group description
    		 -

    Reporting group title
    Part 3 - Other treatment (not adalimumab)
    Reporting group description
    		 -

    Reporting group title
    Adalimumab - entire study period (Part 1, Part 2 and Part 3)
    Reporting group description
    		 -

    Serious adverse events
    		 Part 1 - Adalimumab group Part 1 - Placebo group Part 2 - Adalimumab Part 3 - Adalimumab Part 3 - Other treatment (not adalimumab) Adalimumab - entire study period (Part 1, Part 2 and Part 3)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    1 / 34 (2.94%)
    0 / 6 (0.00%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    1 / 34 (2.94%)
    0 / 6 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part 1 - Adalimumab group Part 1 - Placebo group Part 2 - Adalimumab Part 3 - Adalimumab Part 3 - Other treatment (not adalimumab) Adalimumab - entire study period (Part 1, Part 2 and Part 3)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 24 (12.50%)
    20 / 45 (44.44%)
    16 / 34 (47.06%)
    1 / 6 (16.67%)
    27 / 48 (56.25%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    2 / 34 (5.88%)
    0 / 6 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    2 / 34 (5.88%)
    0 / 6 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    2 / 34 (5.88%)
    0 / 6 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Nausea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    3 / 45 (6.67%)
    0 / 34 (0.00%)
    1 / 6 (16.67%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    3
    0
    1
    3
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    0 / 34 (0.00%)
    1 / 6 (16.67%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 45 (0.00%)
    2 / 34 (5.88%)
    0 / 6 (0.00%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 45 (2.22%)
    3 / 34 (8.82%)
    0 / 6 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    0
    0
    1
    3
    0
    4

    More information

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

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

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