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    Clinical Trial Results:
    STRIKE – Treating Patients with Early Axial Spondyloarthritis to Target – a 1 Year Randomized Controlled Study Taking an Intense Treatment Approach Versus Routine Treatment

    Summary
    EudraCT number
    2015-005398-18
    Trial protocol
    DE  
    Global end of trial date
    21 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Dec 2018
    First version publication date
    28 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    W15-679
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02897115
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Abbvie Deutschland GmbH & Co.KG
    Sponsor organisation address
    House, Vanwall Business Park, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, Abbvie, 011 800-633-9110,
    Scientific contact
    Henning Kleine, Abbvie, henning.kleine@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
    21 Dec 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare an intensified treat-to-target (T2T) treatment approach with standard of care (SOC) in reducing disease activity at Week 32 in patients with early axial spondyloarthritis (axSpA).
    Protection of trial subjects
    The study was conducted in accordance with the protocol, ICH guidelines, applicable regulations and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki. 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
    12 Sep 2016
    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
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study planned to enroll approximately 240 participants at 30 sites in Germany. Due to slow enrollment the study was terminated prematurely; At the time the decision to close the study was made 22 subjects were enrolled at 9 sites in Germany.

    Pre-assignment
    Screening details
    Twenty-six subjects were screened, 22 of whom were randomized. Four of the screened subjects were not randomized; one subject due to premature study termination by the sponsor, one subject withdrew consent during the screening period, and two subjects did not meet inclusion criteria.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treat-to-Target (T2T)
    Arm description
    Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Adamimumab
    Investigational medicinal product code
    ABT-D2E7
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab 40 mg administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.

    Arm title
    Standard of Care (SOC)
    Arm description
    Participants received treatment as prescribed by their physician according to the local standard of care.
    Arm type
    Standard of Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Treat-to-Target (T2T) Standard of Care (SOC)
    Started
    14
    8
    Completed
    3
    0
    Not completed
    11
    8
         Early termination of study by sponsor
    11
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treat-to-Target (T2T)
    Reporting group description
    Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.

    Reporting group title
    Standard of Care (SOC)
    Reporting group description
    Participants received treatment as prescribed by their physician according to the local standard of care.

    Reporting group values
    Treat-to-Target (T2T) Standard of Care (SOC) Total
    Number of subjects
    14 8 22
    Age categorical
    Units: Subjects
        Adults (18-65 years)
    14 8 22
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.0 ± 9.49 29.6 ± 7.96 -
    Gender categorical
    Units: Subjects
        Female
    8 4 12
        Male
    6 4 10

    End points

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    End points reporting groups
    Reporting group title
    Treat-to-Target (T2T)
    Reporting group description
    Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.

    Reporting group title
    Standard of Care (SOC)
    Reporting group description
    Participants received treatment as prescribed by their physician according to the local standard of care.

    Primary: Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32

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    End point title
    Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32 [1]
    End point description
    ASDAS inactive disease is defined as ASDAS < 1.3. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Primary
    End point timeframe
    Week 32
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study terminated early due to slow enrollment and no data were analyzed.
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage of participants
        number (not applicable)
    Notes
    [2] - The study terminated early due to slow enrollment and no data were analyzed.
    [3] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)

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    End point title
    Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)
    End point description
    The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [4] - The study terminated early due to slow enrollment and no data were analyzed.
    [5] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Work Productivity and Activity Impairment – Axial Spondyloarthritis (WPAI-axSpA)

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    End point title
    Change From Baseline in Work Productivity and Activity Impairment – Axial Spondyloarthritis (WPAI-axSpA)
    End point description
    The Work Productivity and Activity Impairment (WPAI) axSpA is an axSpA specific questionnaire consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [6] - The study terminated early due to slow enrollment and no data were analyzed.
    [7] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

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    End point title
    Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
    End point description
    The EQ-5D-3L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-3L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 3 levels of severity (1: indicating no problem, 2: indicating some/moderate problems, 3: indicating extreme problems). A single preference-weighted health utility index score was calculated by applying country-specific weights, with scores ranging from approximately 0 (death) to 1 (full health).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [8] - The study terminated early due to slow enrollment and no data were analyzed.
    [9] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index

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    End point title
    Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index
    End point description
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [10] - The study terminated early due to slow enrollment and no data were analyzed.
    [11] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ASDAS Low Disease Activity

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    End point title
    Percentage of Participants With ASDAS Low Disease Activity
    End point description
    ASDAS low disease activity is defined as an ASDAS < 2.1. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: percentage of participants
        number (not applicable)
    Notes
    [12] - The study terminated early due to slow enrollment and no data were analyzed.
    [13] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ASDAS Moderate Disease Activity

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    End point title
    Percentage of Participants With ASDAS Moderate Disease Activity
    End point description
    ASDAS moderate disease activity is defined as an ASDAS ≥ 1.3 to < 2.1. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: percentage of participants
        number (not applicable)
    Notes
    [14] - The study terminated early due to slow enrollment and no data were analyzed.
    [15] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ASDAS High Disease Activity

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    End point title
    Percentage of Participants With ASDAS High Disease Activity
    End point description
    ASDAS high disease activity is defined as an ASDAS ≥ 2.1 to < 3.5. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: percentage of participants
        number (not applicable)
    Notes
    [16] - The study terminated early due to slow enrollment and no data were analyzed.
    [17] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ASDAS Clinically Important Improvement

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    End point title
    Percentage of Participants Achieving ASDAS Clinically Important Improvement
    End point description
    ASDAS clinically important improvement is defined as a change from baseline ≤ -1.1. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: percentage of participants
        number (not applicable)
    Notes
    [18] - The study terminated early due to slow enrollment and no data were analyzed.
    [19] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ASDAS Major Improvement

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    End point title
    Percentage of Participants Achieving ASDAS Major Improvement
    End point description
    ASDAS Major Improvement is defined as a change from baseline ≤ -2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: percentage of participants
        number (not applicable)
    Notes
    [20] - The study terminated early due to slow enrollment and no data were analyzed.
    [21] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in ASDAS

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    End point title
    Change From Baseline in ASDAS
    End point description
    ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [22] - The study terminated early due to slow enrollment and no data were analyzed.
    [23] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

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    End point title
    Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
    End point description
    The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 (best) to 10 (worst).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [24] - The study terminated early due to slow enrollment and no data were analyzed.
    [25] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ASDAS Inactive Disease at Week 52

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    End point title
    Percentage of Participants With ASDAS Inactive Disease at Week 52
    End point description
    ASDAS inactive disease is defined as ASDAS < 1.3. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: percentage of participants
        number (not applicable)
    Notes
    [26] - The study terminated early due to slow enrollment and no data were analyzed.
    [27] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a BASDAI 50 Response

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    End point title
    Percentage of Participants Achieving a BASDAI 50 Response
    End point description
    The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [28]
    0 [29]
    Units: percentage of participants
        number (not applicable)
    Notes
    [28] - The study terminated early due to slow enrollment and no data were analyzed.
    [29] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ASDAS Very High Disease Activity

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    End point title
    Percentage of Participants With ASDAS Very High Disease Activity
    End point description
    ASDAS very high disease activity is defined as an ASDAS ≥ 3.5. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and > 3.5 for "very high disease activity."
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [30]
    0 [31]
    Units: percentage of participants
        number (not applicable)
    Notes
    [30] - The study terminated early due to slow enrollment and no data were analyzed.
    [31] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response

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    End point title
    Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
    End point description
    ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain: • Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe); • Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe); • Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); • Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [32]
    0 [33]
    Units: percentge of participants
        number (not applicable)
    Notes
    [32] - The study terminated early due to slow enrollment and no data were analyzed.
    [33] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an ASAS 40 Response

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    End point title
    Percentage of Participants Achieving an ASAS 40 Response
    End point description
    ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain: • Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe); • Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe); • Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); • Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [34]
    0 [35]
    Units: percentage of participants
        number (not applicable)
    Notes
    [34] - The study terminated early due to slow enrollment and no data were analyzed.
    [35] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ASAS Partial Remission

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    End point title
    Percentage of Participants Achieving ASAS Partial Remission
    End point description
    ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains: • Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe); • Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe); • Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); • Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [36]
    0 [37]
    Units: percentage of participants
        number (not applicable)
    Notes
    [36] - The study terminated early due to slow enrollment and no data were analyzed.
    [37] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient's Global Assessment of Pain

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    End point title
    Change From Baseline in Patient's Global Assessment of Pain
    End point description
    The Patient's Global Assessment of Pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [38]
    0 [39]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [38] - The study terminated early due to slow enrollment and no data were analyzed.
    [39] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Joint Count

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    End point title
    Change From Baseline in Tender Joint Count
    End point description
    An assessment of 68 joints was performed by physical examination of each joint. Joint pain/tenderness was classified as present (1), absent (0), replaced (9), or no assessment (NA).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [40]
    0 [41]
    Units: tnder joints
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [40] - The study terminated early due to slow enrollment and no data were analyzed.
    [41] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient's Global Assessment of Disease Activity

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    End point title
    Change From Baseline in Patient's Global Assessment of Disease Activity
    End point description
    The Patient's Global Assessment of Disease Activity was assessed using an NRS from 0 (no disease activity) to 10 (very severe disease activity).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [42]
    0 [43]
    Units: nits on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [42] - The study terminated early due to slow enrollment and no data were analyzed.
    [43] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity

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    End point title
    Change From Baseline in Physician's Global Assessment of Disease Activity
    End point description
    The Physician's Global Assessment of Disease Activity was assessed using an NRS from 0 (no disease activity) to 10 (severe disease activity).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [44]
    0 [45]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [44] - The study terminated early due to slow enrollment and no data were analyzed.
    [45] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Active Inflammation of the Sacroiliac Joints and Spine

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    End point title
    Change From Baseline in Active Inflammation of the Sacroiliac Joints and Spine
    End point description
    Active inflammation of the sacroiliac (SI) joints as well as the cervical, thoracic and lumbar regions of the spine was assessed using magnetic resonance imaging (MRI). Images were scored by a central reader according to the Berlin MRI Score on a grading scale from 0 to 3, where Grade 0 indicates no active inflammation and Grade 3 indicates > 66% inflammation of the sacroiliac joints or > 50% active inflammation in the spine.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [46]
    0 [47]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [46] - The study terminated early due to slow enrollment and no data were analyzed.
    [47] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Swollen Joint Count

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    End point title
    Change From Baseline in Swollen Joint Count
    End point description
    An assessment of 66 joints was performed by physical examination of each joint. Joint swelling was classified as present (1), absent (0), replaced (9), or no assessment (NA).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [48]
    0 [49]
    Units: swollen joints
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [48] - The study terminated early due to slow enrollment and no data were analyzed.
    [49] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: ange From Baseline in Dactylitis Count

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    End point title
    ange From Baseline in Dactylitis Count
    End point description
    Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as 0 for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [50]
    0 [51]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [50] - The study terminated early due to slow enrollment and no data were analyzed.
    [51] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in C-reactive Protein (CRP)

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    End point title
    Change From Baseline in C-reactive Protein (CRP)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [52]
    0 [53]
    Units: mg/L
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [52] - The study terminated early due to slow enrollment and no data were analyzed.
    [53] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)

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    End point title
    Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [54]
    0 [55]
    Units: mm/hr
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [54] - The study terminated early due to slow enrollment and no data were analyzed.
    [55] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Number of Participants With New Onset Anterior Uveitis

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    End point title
    Number of Participants With New Onset Anterior Uveitis
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [56]
    0 [57]
    Units: participants
    Notes
    [56] - The study terminated early due to slow enrollment and no data were analyzed.
    [57] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES)

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    End point title
    Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES)
    End point description
    The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at 13 entheses (sites where tendons or ligaments insert into the bone). All sites were scored as 0 (absent) or 1 (present). The MASES is the sum of all site scores (from 0 to 13).
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [58]
    0 [59]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [58] - The study terminated early due to slow enrollment and no data were analyzed.
    [59] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin)

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    End point title
    Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin)
    End point description
    The linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin) is a composite score based on 5 direct measurements of spinal mobility: lateral lumbar flexion, tragus‐to‐wall distance, lumbar flexion, intermalleolar distance, and cervical rotation angle. The total score ranges from 0 to 10, where higher scores indicate more limited mobility.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32, and week 52
    End point values
    Treat-to-Target (T2T) Standard of Care (SOC)
    Number of subjects analysed
    0 [60]
    0 [61]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [60] - The study terminated early due to slow enrollment and no data were analyzed.
    [61] - The study terminated early due to slow enrollment and no data were analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 weeks.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Standard of Care (SOC)
    Reporting group description
    Participants received treatment as prescribed by their physician according to the local standard of care.

    Reporting group title
    Treat-to-Target (T2T)
    Reporting group description
    Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2, participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.

    Serious adverse events
    Standard of Care (SOC) Treat-to-Target (T2T)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    CHOLECYSTITIS CHRONIC
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Standard of Care (SOC) Treat-to-Target (T2T)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    12 / 14 (85.71%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Psychiatric disorders
    MOOD ALTERED
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    DEPRESSION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    SLEEP DISORDER
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    MENSTRUATION IRREGULAR
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    OVARIAN CYST
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    VULVOVAGINAL INFLAMMATION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    LACERATION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    POST-TRAUMATIC NECK SYNDROME
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    LYMPHADENOPATHY
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    DYSAESTHESIA
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    MIGRAINE
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    HEADACHE
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    DYSPEPSIA
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    ANAL FISSURE
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 14 (21.43%)
         occurrences all number
    1
    4
    TOOTHACHE
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    GASTRITIS
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    NAUSEA
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    URTICARIA
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    PSORIASIS
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    AXIAL SPONDYLOARTHRITIS
         subjects affected / exposed
    3 / 8 (37.50%)
    2 / 14 (14.29%)
         occurrences all number
    3
    3
    BACK PAIN
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    3
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    NECK PAIN
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    3 / 8 (37.50%)
    4 / 14 (28.57%)
         occurrences all number
    3
    4
    GASTROENTERITIS
         subjects affected / exposed
    2 / 8 (25.00%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    CYSTITIS
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    BRONCHITIS
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    SINUSITIS
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    4
    RHINITIS
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    PULPITIS DENTAL
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    WOUND INFECTION
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2016
    Key changes include: • Updated Section 5.2.2, Exclusion criteria. Rationale: Amended the criteria upon Ethics Committee’s request, to reflect that vulnerable subjects are not eligible to participate in the study. • Updated Section 5.4.1, Discontinuation of Individual Subjects. Rationale: Upon Ethics Committee’s request, provided more detailed clarification on the reasons for premature study discontinuation of individual subjects by cross-referencing to Section 6.1.7. • Updated Section 5.4.2, Discontinuation of Entire Study. Rationale: Upon Ethics Committee’s request, provided more detailed clarification on the reasons for premature study termination. • Updated Section 6.1.7, Toxicity Management. Rationale: Amended Section text with information on management of selected laboratory abnormalities.
    30 Mar 2017
    The second protocol amendment was written to increase the number of sites to 30. Key changes included: • Updated Section 1.2, Synopsis. Rationale: Added change in BASMIlin to secondary objectives in Objectives and Criteria for Evaluation subsections to align with Section 5.3.1, Table 1 – Study Activities; increased the number of participating study sites to allow for faster enrollment; and aligned the Statistical Methods subsection with the respective wording concerning the safety analyses in Section 8.1.6 of the protocol. • Updated Section 5.1, Overall Study Design and Plan: Description, and Section 5.5.1, Treatments Administered. Rationale: Provided clarification regarding NSAIDs to be used in case of escalation to Escalation Step 2 due to intolerance to NSAID 2. • Updated Section 6.1, Medical Complaints. Rationale: Changed Section title from ‘Adverse Events’ to ‘Medical Complaints’ to align with new protocol template. • Updated Section 6.1.3, Relationship to Humira. Rationale: Updated definitions of reasonable versus no reasonable possibility to align with new protocol template.

    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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