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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

    Summary
    EudraCT number
    		 2015-000289-67
    Trial protocol
    		 BE   HU   DE   CZ  
    Global end of trial date
    26 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Oct 2018
    First version publication date
    12 Oct 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1275AKS3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02407223
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    26 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess the efficacy of ustekinumab in adult subjects with active nr-AxSpA, measured by the reduction in signs and symptoms of nr-AxSpA.
    Protection of trial subjects
    Safety was evaluated based on adverse events (AEs), clinical laboratory tests, vital sign measurements, physical examinations, ECGs (screening only), concomitant medication review, injection-site reactions, allergic reactions, infections, and tuberculosis (TB) evaluations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Australia: 22
    Country: Number of subjects enrolled
    Belgium: 27
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Mexico: 24
    Country: Number of subjects enrolled
    Poland: 45
    Country: Number of subjects enrolled
    Russian Federation: 62
    Country: Number of subjects enrolled
    Taiwan: 23
    Country: Number of subjects enrolled
    Ukraine: 57
    Worldwide total number of subjects
    356
    EEA total number of subjects
    150
    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)
    356
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 356 subjects were randomized and received treatment (116 subjects to placebo, 118 subjects to ustekinumab 45 milligram [mg], and 122 subjects to 90 mg).

    Period 1
    Period 1 title
    Overall Study (overall period)
    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
    		 Placebo
    Arm description
    		 Subjects received placebo SC at Week(W) 0, 4, 16 and 20. At W16, subjects in placebo group who qualified for early escape (EE) criteria (with <10 percent (%) improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) were re-randomized to receive ustekinumab 45mg or 90mg at W 16, 20,28 followed by q12w dosing through W52. Subjects received placebo SC at W24 to maintain the blind. At W24, all remaining subjects in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at W24, 28 followed by q12w therapy through W52. At W52, subjects who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] [ESR]<1.3) at W40,52 underwent re-randomization to either ustekinumab or placebo. Subjects who did not achieve inactive disease either W40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for W88 and last study visit for W100.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo SC injection at Weeks 0, 4, 16 and 20.

    Investigational medicinal product name
    Ustekinumab 45 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 16, subjects in placebo group who qualified for EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Weeks 16, 20 and 28 followed by q12w dosing through Week 52. At Week 24, all remaining subjects in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits.

    Investigational medicinal product name
    Ustekinumab 90 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 16, subjects in placebo group who qualified for EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Weeks 16, 20 and 28 followed by q12w dosing through Week 52. At Week 24, all remaining subjects in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits.

    Arm title
    		 Ustekinumab 45mg
    Arm description
    		 Subjects received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR less than [<]1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for W88 and last study visit for W100.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab 45mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind.

    Arm title
    		 Ustekinumab 90mg
    Arm description
    		 Subjects received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for W88 and last study visit for W100.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab 90mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind.

    Number of subjects in period 1
    		Placebo Ustekinumab 45mg Ustekinumab 90mg
    Started
    116
    118
    122
    Early Escape at Week 16
    22
    0
    0
    Cross over at Week 24
    60
    0
    0
    Qualified Re-randomization at Week 52
    0
    3
    2
    Completed
    0
    0
    0
    Not completed
    116
    118
    122
         Consent withdrawn by subject
    2
    4
    4
         Adverse event
    1
    -
    1
         Study terminated by sponsor
    77
    80
    86
         Unspecified
    29
    27
    25
         Lost to follow-up
    1
    -
    2
         Subject refused further study treatment
    -
    1
    -
         Lack of efficacy
    6
    6
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo SC at Week(W) 0, 4, 16 and 20. At W16, subjects in placebo group who qualified for early escape (EE) criteria (with <10 percent (%) improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) were re-randomized to receive ustekinumab 45mg or 90mg at W 16, 20,28 followed by q12w dosing through W52. Subjects received placebo SC at W24 to maintain the blind. At W24, all remaining subjects in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at W24, 28 followed by q12w therapy through W52. At W52, subjects who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] [ESR]<1.3) at W40,52 underwent re-randomization to either ustekinumab or placebo. Subjects who did not achieve inactive disease either W40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for W88 and last study visit for W100.

    Reporting group title
    Ustekinumab 45mg
    Reporting group description
    		 Subjects received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR less than [<]1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for W88 and last study visit for W100.

    Reporting group title
    Ustekinumab 90mg
    Reporting group description
    		 Subjects received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for W88 and last study visit for W100.

    Reporting group values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg Total
    Number of subjects
    		 116 118 122 356
    Title for AgeCategorical
    Units: subjects
        <30
    		 40 45 39 124
        >=30
    		 76 73 83 232
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ± 8.75 33.9 ± 8.39 34.9 ± 9.06 -
    Title for Gender
    Units: subjects
        Female
    		 52 65 59 176
        Male
    		 64 53 63 180

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo SC at Week(W) 0, 4, 16 and 20. At W16, subjects in placebo group who qualified for early escape (EE) criteria (with <10 percent (%) improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) were re-randomized to receive ustekinumab 45mg or 90mg at W 16, 20,28 followed by q12w dosing through W52. Subjects received placebo SC at W24 to maintain the blind. At W24, all remaining subjects in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at W24, 28 followed by q12w therapy through W52. At W52, subjects who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] [ESR]<1.3) at W40,52 underwent re-randomization to either ustekinumab or placebo. Subjects who did not achieve inactive disease either W40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for W88 and last study visit for W100.

    Reporting group title
    Ustekinumab 45mg
    Reporting group description
    		 Subjects received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR less than [<]1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for W88 and last study visit for W100.

    Reporting group title
    Ustekinumab 90mg
    Reporting group description
    		 Subjects received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for W88 and last study visit for W100.

    Primary: Percentage of Subjects Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24

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    End point title
    		 Percentage of Subjects Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
    End point description
    ASAS20:>=20% improvement and absolute improvement from baseline of 1 on 0-10 cm scale in at least 3 of following: PGA disease activity(0-10 cm; 0=very well,10=very poor), total back pain(0-10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment given as mean [0-10cm; 0=easy, 10=impossible]) of 10 questions, 8 relates to functional anatomy and 2 to ability to cope with everyday life), Inflammation(0-10cm;0=none,10=very severe); absence of deterioration(>=20% and worsening of at least 1 on 0-10 cm scale) in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders[NR] at and after treatment failure), EE rules (consider NR at Week 20 and 24), NRI(missing responses at post baseline visit imputed as NRI). MFAS-subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment received.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
        number (not applicable)
    47.6
    55.4
    49.4
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Ustekinumab 45mg
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.232
    Method
    		 CMH chi-square test
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 23.1
    Statistical analysis title
    		 Stastical analysis 2
    Comparison groups
    Placebo v Ustekinumab 90mg
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.876
    Method
    		 CMH chi-square test
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 17

    Secondary: Percentage of Subjects Who Achieved an ASAS 40 Response at Week 24

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    End point title
    		 Percentage of Subjects Who Achieved an ASAS 40 Response at Week 24
    End point description
    ASAS40: >=40% improvement and absolute improvement from baseline of at least 2 on 0-10 cm scale in at least 3 of following: PGA of disease activity (0-10 cm; 0=very well,10=very poor),total back pain (0-10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment given as mean (0-10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 to subjects ability to cope with everyday life), Inflammation (0-10 cm;0=none,10=very severe); no worsening at all in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders [NR] at and after treatment failure), EE rules (consider NR at Week 20 and 24), NRI (missing responses at post baseline visit imputed as NR). MFAS- subjects who were randomized (those who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
        number (not applicable)
    25.6
    33.7
    28.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24

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    End point title
    		 Percentage of Subjects Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
    End point description
    BASDAI consists of 6 questions: fatigue, spinal pain, arthralgia/swelling, enthesitis and morning stiffness (2 questions: duration and severity). Each question to answer 10cm visual analog scale (VAS), with 0=none, and 10=very severe. To give each of 5 symptoms equal weight, mean of 2 questions about morning stiffness were added to total of the remaining 4 scores and final BASDAI score (ranging 0-10) is average of overall total score. Higher score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure (consider non-responders [NR] at and after treatment failure),EE rules (consider NR at Week 20 and 24), NR imputation (missing responses at post baseline visit imputed as NR). MFAS- subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
        number (not applicable)
    23.2
    32.5
    25.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24

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    End point title
    		 Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
    End point description
    BASFI- composed with 10 questions (each question is answered with a VAS 0-10 cm) to assess disease severity, including first 8 questions regarding to functional anatomy related activities and the 2 questions related to daily activities of AS subjects. Each question is a 10 cm VAS with a value between 0 (easy) and 10 (impossible). Final BASFI score is mean of 10 scores. BASFI score is average of 10 responses and has a possible minimum value of 0 and maximum value of 10. Higher score indicates more severe functional limitations of the subject due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). MFAS- subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received. 'N' signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    61
    72
    63
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.11 ± 2.371
    -2.28 ± 2.625
    -1.90 ± 2.731
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive protein (CRP) Inactive Disease (<1.3) at Week 24

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    End point title
    		 Percentage of Subjects who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive protein (CRP) Inactive Disease (<1.3) at Week 24
    End point description
    ASDAS: CRP (mg/L) with 4 items (on 0-10 cm VAS or 0-10 numerical rating scale [NRS]) having total back pain, duration of morning stiffness, peripheral pain/swelling and PGA. ASDAS scores- ASDAS(CRP)=(0.121*total back pain)+(0.110*subject global)+(0.073*peripheral pain/swelling)+(0.058*duration of morning stiffness)+ (0.579*Ln(CRP+1)). Disease activity, TBP and peripheral pain/swelling on NRS (0 [normal] to 10 [very severe] and DMS on NRS (0-10, 0=none, 10-duration of =>2 hours). Inactive disease- an ASDAS score <1.3. ASDAS (CRP). It is based on imputed data using treatment failure(consider non-responders [NR] at and after treatment failure), EE rules(consider NR at W 20 and 24), NR imputation(missing responses at post baseline imputed as NR). MFAS-subjects who randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received atleast 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    85
    85
    Units: Percentage of subjects
        number (not applicable)
    7.3
    14.5
    12.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24

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    End point title
    		 Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
    End point description
    Change from baseline in hsCRP levels was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Missing values were imputed using early escape rule (measurement value at Week 20 and Week 24 was set as missing). MFAS-subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received. Here 'n'-number of subjects who were analyzed at each specified timepoints, for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16, 20 and 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Milligrams per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Change at Week 4(n=82,83,84)
    -0.08 ± 1.567
    -0.10 ± 2.574
    -0.39 ± 1.601
        Change at Week 8(n=82,82,82)
    -0.23 ± 1.490
    -0.53 ± 2.084
    -0.57 ± 2.209
        Change at Week 12(n=80,81,81)
    -0.23 ± 1.661
    -0.71 ± 2.392
    -0.61 ± 2.534
        Change at Week 16(n=79,82,80)
    -0.49 ± 1.725
    -0.63 ± 2.21
    -0.61 ± 2.539
        Change at Week 20(n=61,80,80)
    -0.36 ± 1.951
    -0.78 ± 2.353
    -0.76 ± 2.383
        Change at Week 24(n=62,79,79)
    -0.42 ± 2.145
    -0.63 ± 2.402
    -0.78 ± 2.413
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With ASAS 20 Components at Week 24

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    End point title
    		 Percentage of Subjects With ASAS 20 Components at Week 24
    End point description
    ASAS 20 defined as >= 20% improvement from baseline in 4 individual components of ASAS20: Patient’s global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to subjects ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe). MFAS- subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received. 'N' signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    78
    80
    80
    Units: Percentage of subjects
    number (not applicable)
        >=20% improvement from baseline in PGA score
    64.1
    61.3
    58.8
        >=20% improvement from baseline in total back pain
    62.8
    60.0
    60.0
        >=20% improvement from baseline in BASFI
    53.8
    57.5
    56.3
        >=20% improvement from baseline in inflammation
    64.1
    66.3
    65.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20

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    End point title
    		 Percentage of Subjects Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
    End point description
    ASAS40: >=40% improvement and absolute improvement from baseline of at least 2 on 0-10 cm scale in at least 3 of following: PGA of disease activity (0-10 cm; 0=very well,10=very poor),total back pain (0-10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment given as mean (0-10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 to subjects ability to cope with everyday life), Inflammation (0-10 cm;0=none,10=very severe); no worsening at all in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders [NR] at and after treatment failure), EE rules (consider NR at Week 20 and 24), NRI (missing responses at post baseline visit imputed as NR). MFAS- subjects who were randomized (those who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Week 4 ,8 ,12 ,16 and 20
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    3.7
    8.4
    11.8
        Week 8
    18.3
    19.3
    18.8
        Week 12
    17.1
    27.7
    24.7
        Week 16
    19.5
    27.7
    24.7
        Week 20
    24.4
    38.6
    32.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20

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    End point title
    		 Percentage of Subjects Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
    End point description
    ASAS20:>=20% improvement and absolute improvement from baseline of 1 on 0-10 cm scale in at least 3 of following: PGA disease activity(0-10 cm; 0=very well,10=very poor), total back pain(0-10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment given as mean [0-10cm; 0=easy, 10=impossible]) of 10 questions, 8 relates to functional anatomy and 2 to ability to cope with everyday life), Inflammation(0-10cm;0=none,10=very severe); absence of deterioration(>=20% and worsening of at least 1 on 0-10 cm scale) in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders[NR] at and after treatment failure), EE rules (consider NR at Week 20 and 24), NRI(missing responses at post baseline visit imputed as NRI). MFAS-subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment received.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16 and 20
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    23.2
    26.5
    32.9
        Week 8
    31.7
    41.0
    36.5
        Week 12
    34.1
    48.2
    41.2
        Week 16
    40.2
    49.4
    35.3
        Week 20
    45.1
    59.0
    44.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20

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    End point title
    		 Percentage of Subjects Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
    End point description
    BASDAI consists of 6 questions: fatigue, spinal pain, arthralgia/swelling, enthesitis and morning stiffness (2 questions: duration and severity). Each question to answer 10cm visual analog scale (VAS), with 0=none, and 10=very severe. To give each of 5 symptoms equal weight, mean of 2 questions about morning stiffness were added to total of the remaining 4 scores and final BASDAI score (ranging 0-10) is average of overall total score. Higher score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure (consider non-responders [NR] at and after treatment failure),EE rules (consider NR at Week 20 and 24), NR imputation (missing responses at post baseline visit imputed as NR). MFAS- subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, and 20
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    4.9
    8.4
    8.2
        Week 8
    9.8
    15.7
    17.6
        Week 12
    18.3
    16.9
    28.2
        Week 16
    19.5
    21.7
    24.7
        Week 20
    15.9
    28.9
    32.9
        Week 24
    23.2
    33.7
    25.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20

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    End point title
    		 Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20
    End point description
    BASFI is composed of 10 questions (each answered on VAS 0-10 cm) to assess disease severity, first 8 questions regarding to functional anatomy related activities and other 2 questions related to daily activities. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). Final BASFI score is mean of 10 scores. BASFI score is average of 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the subject due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). MFAS-subjects who were randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment received. 'n' defined as number of subjects who were analyzed at each specified timepoints, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 16 and 20
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 4
    -0.60 ± 1.582
    -1.15 ± 1.748
    -0.79 ± 1.600
        Change at Week 8
    -0.82 ± 1.997
    -1.54 ± 2.117
    -1.05 ± 2.095
        Change at Week 12
    -1.00 ± 2.064
    -1.69 ± 2.079
    -1.35 ± 2.458
        Change at Week 16
    -1.05 ± 2.162
    -1.75 ± 2.312
    -1.17 ± 2.747
        Change at Week 20
    -1.70 ± 2.339
    -2.11 ± 2.394
    -1.64 ± 2.794
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20

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    End point title
    		 Percentage of Subjects with ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20
    End point description
    ASDAS: CRP (mg/L) with 4 items (on 0-10cm VAS or 0-10 numerical rating scale [NRS]) having total back pain, duration of morning stiffness, peripheral pain/swelling and PGA. ASDAS scores- ASDAS(CRP)=(0.121*total back pain)+(0.110*subject global)+(0.073*peripheral pain/swelling)+(0.058*duration of morning stiffness)+ (0.579*Ln(CRP+1). Disease activity, TBP and peripheral pain/swelling on NRS (0 [normal] to 10 [very severe] and DMS on NRS (0-10, 0=none, 10-duration of =>2 hours). Inactive disease- an ASDAS score <1.3. ASDAS (CRP). It is based on imputed data using treatment failure(consider non-responders [NR] at and after treatment failure), EE rules(consider NR at Week 20 and 24), NR imputation(missing responses at post baseline imputed as NR). MFAS-subjects who randomized (those subjects who would have been able to complete Week 24 at time of study discontinuation) and received atleast 1 dose of study drug. Subjects were analyzed per assigned treatment regardless of actual treatment.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, and 20
    End point values
    		 Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    82
    83
    85
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    2.4
    3.6
    1.2
        Week 8
    6.1
    7.2
    9.4
        Week 12
    4.1
    4.8
    10.6
        Week 16
    6.1
    7.2
    11.8
        Week 20
    3.7
    13.3
    15.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately up to 2.2 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo Only
    Reporting group description
    		 Subjects received placebo SC at Week 0, 4, 16 and 20. At Week 16, subjects in placebo group who qualified for EE criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) were re-randomized to receive ustekinumab 45mg or 90mg at Weeks 16, 20 and 28 followed by q12w dosing through Week 52. Subjects received placebo SC at W24 to maintain the blind. At Week 24, all remaining subjects in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, all subjects who achieved inactive disease (ASDAS [ESR]<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits.

    Reporting group title
    Placebo to Ustekinumab 45mg
    Reporting group description
    		 Subjects randomized to placebo SC at Week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 45 mg SC; adverse events are counted from crossover onward. All subjects regardless qualified for re-randomization at Week 52 or not were counted.

    Reporting group title
    Placebo to Ustekinumab 90mg
    Reporting group description
    		 Subjects randomized to placebo SC at week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 90 mg SC; adverse events are counted from crossover onward. All subjects regardless qualified for re-randomization at Week 52 or not were counted.

    Reporting group title
    Ustekinumab 45mg Only
    Reporting group description
    		 Subjects received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind. At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All subjects regardless qualified for re-randomization at Week 52 or not were counted.

    Reporting group title
    Ustekinumab 90mg Only
    Reporting group description
    		 Subjects received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, subjects received placebo subcutaneously to maintain the blind.At Week 52, all subjects who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Subjects who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All subjects regardless qualified for re-randomization at Week 52 or not were counted.

    Serious adverse events
    		 Placebo Only Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 90mg Only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 116 (1.72%)
    0 / 42 (0.00%)
    2 / 40 (5.00%)
    2 / 118 (1.69%)
    6 / 122 (4.92%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Uveitis
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal Hernia
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Haemorrhagic Ovarian Cyst
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic Attack
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 118 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Axial Spondyloarthritis
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 118 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Chronic Sinusitis
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 116 (0.00%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Only Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 90mg Only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 116 (16.38%)
    4 / 42 (9.52%)
    12 / 40 (30.00%)
    27 / 118 (22.88%)
    27 / 122 (22.13%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    3 / 116 (2.59%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    5 / 118 (4.24%)
    4 / 122 (3.28%)
         occurrences all number
    4
    1
    2
    6
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 42 (0.00%)
    2 / 40 (5.00%)
    3 / 118 (2.54%)
    4 / 122 (3.28%)
         occurrences all number
    1
    0
    2
    6
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 116 (1.72%)
    0 / 42 (0.00%)
    4 / 40 (10.00%)
    1 / 118 (0.85%)
    2 / 122 (1.64%)
         occurrences all number
    3
    0
    4
    1
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    2 / 118 (1.69%)
    2 / 122 (1.64%)
         occurrences all number
    2
    1
    2
    2
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 116 (1.72%)
    0 / 42 (0.00%)
    2 / 40 (5.00%)
    1 / 118 (0.85%)
    3 / 122 (2.46%)
         occurrences all number
    2
    0
    3
    1
    4
    Back Pain
         subjects affected / exposed
    2 / 116 (1.72%)
    1 / 42 (2.38%)
    3 / 40 (7.50%)
    2 / 118 (1.69%)
    3 / 122 (2.46%)
         occurrences all number
    2
    1
    4
    2
    4
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    1 / 116 (0.86%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    0 / 118 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 116 (4.31%)
    2 / 42 (4.76%)
    2 / 40 (5.00%)
    5 / 118 (4.24%)
    8 / 122 (6.56%)
         occurrences all number
    6
    2
    2
    5
    8
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    6 / 116 (5.17%)
    1 / 42 (2.38%)
    1 / 40 (2.50%)
    11 / 118 (9.32%)
    9 / 122 (7.38%)
         occurrences all number
    6
    1
    1
    12
    10

    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? Yes
    Date
    Interruption
    Restart date
    22 May 2017
    This study was discontinued due to lack of efficacy of either 45 mg or 90 mg dose of ustekinumab observed in the CNTO1275AKS3001 study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was discontinued before it was fully enrolled, therefore, the interpretation of the efficacy data is limited.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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