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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 Anti-TNFα Refractory Subjects With Active Radiographic Axial Spondyloarthritis

    Summary
    EudraCT number
    2015-000288-16
    Trial protocol
    HU   DE   ES   CZ   BE   PL   BG   GB   PT  
    Global end of trial date
    31 Aug 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Sep 2018
    First version publication date
    15 Sep 2018
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1275AKS3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02438787
    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
    31 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 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 antitumor necrosis factor alpha (TNFα) refractory subjects with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.
    Protection of trial subjects
    Safety was evaluated based on adverse events (AEs), clinical laboratory tests, vital sign measurements, physical examinations, electrocardiograms (ECGs, screening only), concomitant medication review, injection-site reactions, allergic reactions, infections, and tuberculosis (TB) evaluations. This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Aug 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
    Spain: 11
    Country: Number of subjects enrolled
    Taiwan: 29
    Country: Number of subjects enrolled
    Ukraine: 66
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Argentina: 7
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Brazil: 10
    Country: Number of subjects enrolled
    Bulgaria: 13
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    Mexico: 22
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Russian Federation: 69
    Worldwide total number of subjects
    315
    EEA total number of subjects
    88
    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)
    306
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 315 subjects were randomized and treated (104 subjects to placebo, 106 subjects to ustekinumab 45 milligram (mg), and 105 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
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week (W) 16, subjects who met early escape (EE) criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) were administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all subjects (with the exception of subjects who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
    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, and 16.

    Investigational medicinal product name
    Golimumab
    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 golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52.

    Investigational medicinal product name
    Ustekinumab 45 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
    Subjects (with the exception of subjects who qualified for EE) were re-randomized and received ustekinumab 45 mg at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52.

    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
    Subjects (with the exception of subjects who qualified for EE) were re-randomized and received ustekinumab 90 mg at Weeks 24 and 28 q12w dosing, with the last administration of study agent at Week 52.

    Arm title
    Ustekinumab 45mg
    Arm description
    Subjects received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, subjects were to receive placebo SC injection to maintain the blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    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 injection at Weeks 0, 4, and 16, followed by q12w dosing, with the last administration of study agent at Week 52.

    Investigational medicinal product name
    Golimumab
    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 golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.

    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 to maintain the blind at Week 24.

    Arm title
    Ustekinumab 90mg
    Arm description
    Subjects received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, Subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, subjects received placebo SC injection to maintain the blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Ustekinumab
    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 SC injection at Weeks 0, 4 followed by q12w dosing, with the last administration of study agent at Week 52.

    Investigational medicinal product name
    Golimumab
    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 golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo SC injection to maintain the blind at Week 24.

    Number of subjects in period 1
    Placebo Ustekinumab 45mg Ustekinumab 90mg
    Started
    104
    106
    105
    Early escape at week 16
    21 [1]
    21 [2]
    20 [3]
    Cross over at week 24
    43
    0 [4]
    0 [5]
    Completed
    23
    23
    22
    Not completed
    81
    83
    83
         Protocol deviation
    -
    -
    1
         Adverse event
    1
    -
    2
         Study discontinued by sponsor
    64
    72
    69
         Lack of efficacy
    1
    2
    -
         Site terminated by sponsor
    -
    -
    1
         Unspecified
    -
    1
    -
         Consent withdrawn by subject
    15
    7
    10
         Lost to follow-up
    -
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who did not met EE criteria at W16 were crossed over to Ustekinumab 45 and 90 mg at W24.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who did not met EE criteria at W16 were crossed over to Ustekinumab 45 and 90 mg at W24.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who did not met EE criteria at W16 were crossed over to Ustekinumab 45 and 90 mg at W24.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who did not met EE criteria at W16 were crossed over to Ustekinumab 45 and 90 mg at W24.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects who did not met EE criteria at W16 were crossed over to Ustekinumab 45 and 90 mg at W24.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week (W) 16, subjects who met early escape (EE) criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) were administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all subjects (with the exception of subjects who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.

    Reporting group title
    Ustekinumab 45mg
    Reporting group description
    Subjects received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, subjects were to receive placebo SC injection to maintain the blind.

    Reporting group title
    Ustekinumab 90mg
    Reporting group description
    Subjects received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, Subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, subjects received placebo SC injection to maintain the blind.

    Reporting group values
    Placebo Ustekinumab 45mg Ustekinumab 90mg Total
    Number of subjects
    104 106 105 315
    Title for AgeCategorical
    Units: subjects
        <65
    101 103 102 306
        >=65
    3 3 3 9
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    40.8 ± 11.72 41.4 ± 11.33 41.5 ± 11.02 -
    Title for Gender
    Units: subjects
        Female
    24 18 13 55
        Male
    80 88 92 260

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week (W) 16, subjects who met early escape (EE) criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) were administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all subjects (with the exception of subjects who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.

    Reporting group title
    Ustekinumab 45mg
    Reporting group description
    Subjects received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, subjects were to receive placebo SC injection to maintain the blind.

    Reporting group title
    Ustekinumab 90mg
    Reporting group description
    Subjects received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, Subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, subjects received placebo SC injection to maintain the blind.

    Primary: Percentage of Subjects who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24

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    End point title
    Percentage of Subjects who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
    End point description
    ASAS 40:Improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of 4 domains: Patient's global assessment(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 to 10 cm; 0=easy,10=impossible) of 10 questions,8 of relate to participant's functional anatomy,2 relate to participant's ability to cope with life), Inflammation(0 to 10cm;0=none,10=very severe);no worsening at all from baseline in remaining domain. Response is based on imputed data using treatment failure(TF)(consider non-responders at and after TF),EE rule(consider non-responder at W20,24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder). FAS: subjects randomized and received at least one dose of study agent. Subjects analyzed based on randomized treatment group assigned, regardless of treatment received.
    End point type
    Primary
    End point timeframe
    Week (W) 24
    End point values
    Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    73
    73
    67
    Units: Percentage of subjects
        number (not applicable)
    12.3
    19.2
    26.9
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Ustekinumab 45mg v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    6.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.9
         upper limit
    18.6
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v Ustekinumab 90mg
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Percentage difference
    Point estimate
    14.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.5
         upper limit
    27.6

    Secondary: Percentage of Subjects who Achieved an ASAS 20 Response at Week 24

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    End point title
    Percentage of Subjects who Achieved an ASAS 20 Response at Week 24
    End point description
    ASAS 20: Improvement from baseline of >= 20% from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (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 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with life), Inflammation(0 to 10cm;0=none,10=very severe);absence of deterioration (>= 20% and worsening of at least 1 on 0 to 10cm scale) from baseline in remaining domain. Response based on imputed data using TF(consider non-responders at and after TF),EE rule(consider non-responder at W 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder). MFAS population was used. Subjects analyzed based on randomized treatment group assigned, regardless of treatment received.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    73
    73
    67
    Units: Percentage of subjects
        number (not applicable)
    27.4
    31.5
    37.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved at Least a 50 Percent (%) 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 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
    End point description
    BASDAI used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm VAS, with 0 being none,10 being very severe and for last question related to MS duration: 0(0 hours[h]),10(2 or more hours). Order to give 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores, final BASDAI score(0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using TF (consider non-responders at and after TF),EE rules(consider non-responder at W20.24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder). Modified-FAS population was used. Subjects analyzed based on randomized treatment group assigned, regardless of treatment received.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    73
    73
    67
    Units: Percentage of subjects
        number (not applicable)
    11.0
    15.1
    28.4
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24
    End point description
    BASFI is composed with 10 questions(question is answered with visual analogue scale 0-10 cm assess disease severity, first 8 questions regarding to functional anatomy related activities and 2 questions related to daily activities of AS. Each question is a10cm VAS value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of 10 scores.BASFI score is average of 10 responses, min. value of 0 and max. value 10. Higher BASFI score shows more severe functional limitations due to AS. Missing data were imputed using early escape (consider non-responder at Wk 20,24). Modified-FAS population was used. Subjects analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' signifies number of Subjects 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
    44
    44
    42
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.29 ± 2.219
    -1.74 ± 2.724
    -2.17 ± 2.438
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) (CRP) (<1.3) Inactive Disease at Week 24
    End point description
    ASDAS includes CRP mg/L;4 self-reported items:total back pain(TBP), duration of morning stiffness(DMS),peripheral pain (PP),patient global assessment (PGA).ASDAS scores (=0.121*TBP)+(0.110*PGA)+(0.073*PP)+(0.058*DMS)+(0.579*Ln(CRP+1).Disease activity,TBP,PP on numeric rating scale (0(normal)-10 (very severe) ,DMS (0 to 10, with 0 being none and 10 representing duration of =>2 hrs). Inactive disease defined as an ASDAS score <1.3. Missing data is imputed using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder). Modified-FAS population was used. Subjects analyzed based on randomized treatment group they were assigned to regardless of treatment received.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Ustekinumab 45mg Ustekinumab 90mg
    Number of subjects analysed
    73
    73
    67
    Units: Percentage of subjects
        number (not applicable)
    0
    2.7
    3.0
    No statistical analyses for this end point

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

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    End point title
    Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Through Week 24
    End point description
    Change from baseline in hsCRP was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). Modified-FAS population was used. Subjects analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of subjects analyzed for the 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
    73
    73
    67
    Units: Milligrams per deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Change at week 4 (n=71,69,67)
    0.12 ± 2.211
    -0.35 ± 2.171
    -0.12 ± 1.604
        Change at week 8 (n=69,68,65)
    -0.18 ± 2.526
    -0.54 ± 2.213
    -0.24 ± 2.555
        Change at week 12 (n=68,68,64)
    -0.02 ± 2.836
    -0.36 ± 2.495
    0.05 ± 2.842
        Change at week 16 (n=66,67,64)
    -0.06 ± 2.676
    -0.21 ± 2.333
    0.12 ± 2.720
        Change at week 20 (n=42,45,44)
    0.23 ± 2.266
    -0.11 ± 1.611
    -0.40 ± 2.198
        Change at week 24 (n=43,44,43)
    -0.36 ± 2.067
    -0.14 ± 2.041
    -0.26 ± 1.850
    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 include CRP mg/L;4 self-reported items:total back pain(TBP), duration of morning stiffness(DMS), peripheral pain (PP),patient global assessment (PGA).ASDAS scores (=0.121*TBP)+(0.110*PGA)+(0.073*PP)+(0.058*DMS)+(0.579*Ln(CRP+1).Disease activity,TBP,PP on numeric rating scale (0(normal)-10 (very severe) ,DMS (0 to 10, with 0 being none and 10 representing duration of =>2 hrs). Inactive disease defined as an ASDAS score <1.3. Missing data is imputed using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder). Modified-FAS population was used. Subjects analyzed based on randomized treatment group they were assigned to regardless of 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
    73
    73
    67
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    0
    0
    0
        Week 8
    0
    2.7
    0
        Week 12
    0
    1.4
    3.0
        Week 16
    0
    1.4
    3.0
        Week 20
    1.4
    1.4
    1.5
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
    End point description
    ASAS 40:Improvement from baseline of >=40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of 4 domains: Patient's global assessment(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 to 10 cm; 0=easy,10=impossible) of 10 questions,8 of relate to participant's functional anatomy,2 relate to participant's ability to cope with life), Inflammation(0 to 10cm;0=none,10=very severe);no worsening at all from baseline in remaining domain. Response is based on imputed data using treatment failure(TF)(consider non-responders at and after TF),EE rule(consider non-responder at W20,24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder). FAS: subjects randomized and received at least one dose of study agent. Subjects analyzed based on randomized treatment group assigned, regardless of 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
    73
    73
    67
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    6.8
    8.2
    11.9
        Week 8
    11.0
    12.3
    16.4
        Week 12
    6.8
    15.1
    19.4
        Week 16
    9.6
    15.1
    20.9
        Week 20
    12.3
    21.9
    25.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20

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    End point title
    Percentage of Participants who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
    End point description
    ASAS 20: Improvement from baseline of >= 20% from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (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 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with life), Inflammation(0 to 10cm;0=none,10=very severe);absence of deterioration (>= 20% and worsening of at least 1 on 0 to 10cm scale) from baseline in remaining domain. Response based on imputed data using TF(consider non-responders at and after TF),EE rule(consider non-responder at W 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder). MFAS population was used. Subjects analyzed based on randomized treatment group assigned, regardless of 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
    73
    73
    67
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    19.2
    26.0
    31.3
        Week 8
    20.5
    34.2
    29.9
        Week 12
    24.7
    30.1
    32.8
        Week 16
    23.3
    21.9
    35.8
        Week 20
    28.8
    35.6
    41.8
    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 used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm VAS, with 0 being none,10 being very severe and for last question related to MS duration: 0(0 hours[h]),10(2 or more hours). Order to give 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores, final BASDAI score(0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using TF (consider non-responders at and after TF),EE rules(consider non-responder at W20.24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder). Modified-FAS population was used. Subjects analyzed based on randomized treatment group assigned, regardless of 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
    73
    73
    67
    Units: Percentage of subjects
    number (not applicable)
        Week 4
    5.5
    6.8
    11.9
        Week 8
    8.2
    11.0
    13.4
        Week 12
    4.1
    15.1
    11.9
        Week 16
    11.0
    15.1
    16.4
        Week 20
    8.2
    16.4
    19.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20

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    End point title
    Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
    End point description
    BASFI composed with 10questions(question answered with visual analogue scale 0-10 cm assess disease severity, first 8 questions regarding to functional anatomy related activities and 2questions related to daily activities of AS. Each question is10cm VAS value between 0(easy) and10 (impossible). The final BASFI score is mean of 10 scores.BASFI score is average of 10 responses, min. value of 0 and max. value100. Higher BASFI score shows more severe functional limitations due to AS. Missing data were imputed using early escape (consider non-responder at Wk 20,24). Modified-FAS population was used. Subjects analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of subjects analyzed for this endpoint at specific timepoints.
    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
    73
    73
    67
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 4 (n=71,69,66)
    -0.58 ± 1.571
    -0.69 ± 1.662
    -0.73 ± 1.915
        Change at Week 8 (n=69,68,64)
    -0.66 ± 2.099
    -0.86 ± 2.010
    -1.02 ± 2.010
        Change at Week 12 (n=68,68,63)
    -0.73 ± 2.406
    -0.70 ± 2.380
    -0.77 ± 2.459
        Change at Week 16 (n=66,67,63)
    -0.58 ± 2.053
    -0.54 ± 2.491
    -0.80 ± 2.574
        Change at Week 20 (n=41,45,43)
    -1.45 ± 2.353
    -1.73 ± 2.564
    -2.16 ± 2.140
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 64
    Adverse event reporting additional description
    The safety analysis set included all subjects who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo SC injection at Weeks 0, 4, and 16. At Week 16, subjects who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all subjects (with the exception of subjects who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing. Included all subjects, but adverse events for subjects who early escaped at Week 16 or crossed over at Week 24 are only counted up to Week 16 or Week 24 respectively.

    Reporting group title
    Placebo to Golimumab
    Reporting group description
    Subjects randomized to placebo SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.

    Reporting group title
    Placebo to Ustekinumab 45mg
    Reporting group description
    Subjects randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.

    Reporting group title
    Placebo to Ustekinumab 90mg
    Reporting group description
    Subjects randomized to placebo SC and then re randomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.

    Reporting group title
    Ustekinumab 45mg Only
    Reporting group description
    Subjects received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing. Adverse events for subjects who early escaped at Week 16 are only counted up to Week 16.

    Reporting group title
    Ustekinumab 45mg to Golimumab
    Reporting group description
    Subjects randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.

    Reporting group title
    Ustekinumab 90mg Only
    Reporting group description
    Subjects received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing. Adverse events for subjects who early escaped at Week 16 are only counted up to Week 16.

    Reporting group title
    Ustekinumab 90mg to Golimumab
    Reporting group description
    Subjects randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.

    Serious adverse events
    Placebo Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90mg Only Ustekinumab 90mg to Golimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    3 / 106 (2.83%)
    1 / 21 (4.76%)
    6 / 105 (5.71%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Myocardial Ischaemia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Iritis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine Polyp
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    1 / 21 (4.76%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Amyloidosis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Axial Spondyloarthritis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    2 / 105 (1.90%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90mg Only Ustekinumab 90mg to Golimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 104 (18.27%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    1 / 22 (4.55%)
    19 / 106 (17.92%)
    7 / 21 (33.33%)
    18 / 105 (17.14%)
    10 / 20 (50.00%)
    Injury, poisoning and procedural complications
    Ligament Sprain
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    6 / 104 (5.77%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    2 / 106 (1.89%)
    2 / 21 (9.52%)
    4 / 105 (3.81%)
    2 / 20 (10.00%)
         occurrences all number
    9
    0
    0
    1
    2
    2
    4
    2
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    5 / 104 (4.81%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 22 (4.55%)
    2 / 106 (1.89%)
    2 / 21 (9.52%)
    3 / 105 (2.86%)
    1 / 20 (5.00%)
         occurrences all number
    7
    0
    0
    1
    2
    2
    3
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    4 / 106 (3.77%)
    1 / 21 (4.76%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    0
    5
    1
    1
    1
    Eye disorders
    Vitreous Haemorrhage
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Injection Site Bruising
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 104 (4.81%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    5
    0
    0
    0
    1
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Skin Disorder
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Spondylitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    1 / 106 (0.94%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    2 / 106 (1.89%)
    0 / 21 (0.00%)
    0 / 105 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    2 / 104 (1.92%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    3 / 106 (2.83%)
    0 / 21 (0.00%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    0
    0
    3
    0
    1
    1
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    0 / 106 (0.00%)
    1 / 21 (4.76%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    Viral Infection
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    2 / 106 (1.89%)
    1 / 21 (4.76%)
    1 / 105 (0.95%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    0
    0
    2
    1
    1
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 104 (3.85%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 22 (0.00%)
    4 / 106 (3.77%)
    2 / 21 (9.52%)
    8 / 105 (7.62%)
    1 / 20 (5.00%)
         occurrences all number
    4
    0
    0
    0
    4
    2
    10
    1

    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
    17 May 2017
    The study was discontinued before it was fully enrolled due to lack of efficacy of either dose of ustekinumab 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.
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