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    Clinical Trial Results:
    Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy COSMOS

    Summary
    EudraCT number
    		 2018-003214-41
    Trial protocol
    		 BE   FR   GB   ES   PL   PT   HU   BG   GR   IT  
    Global end of trial date
    11 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Nov 2021
    First version publication date
    17 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959PSA3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03796858
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development, LLC
    Sponsor organisation address
    920, US Highway, Route 202, South Raritan, United States, 08869
    Public contact
    Janssen Research and Development, LLC, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research and Development, LLC, Clinical Registry Group, 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
    11 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate guselkumab efficacy versus placebo in subjects with active Psoriatic Arthritis (PsA) and an inadequate response to anti-tumor necrosis factor alpha (anti-TNF alpha) therapy by assessing the reduction in signs and symptoms of joint and skin disease.
    Protection of trial subjects
    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. The safety evaluations included monitoring of adverse events, serious adverse events (SAEs), injection site and allergic reactions, clinical laboratory parameters (hematology and chemistry; urine pregnancy test), electronic Columbia-Suicide Severity Rating Scale (eC-SSRS), physical examinations, vital signs and electrocardiogram (ECG; Week 0 only).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Russian Federation: 95
    Country: Number of subjects enrolled
    Ukraine: 74
    Worldwide total number of subjects
    285
    EEA total number of subjects
    101
    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)
    258
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 285 subjects were randomized to receive study intervention;189 subjects were randomized to the guselkumab treatment group and 96 subjects were randomized to the placebo treatment group.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Guselkumab 100 mg q8w
    Arm description
    		 Subjects received GUS (guselkumab) 100 milligrams (mg) subcutaneously (SC) at Weeks 0 and 4, then every 8 weeks 12, 20, 28, 36, through Week (Wk) 44 with placebo SC administered at Week 24. At Week 16, subjects who met the early escape (EE) criteria received placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Guselkumab
    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 guselkumab 100 mg SC at pre-specified timepoints.

    Arm title
    		 Group 2: Placebo
    Arm description
    		 Subjects received placebo subcutaneously (SC) at Weeks 0, 4, 12, and 20 and crossed over at Week 24 to guselkumab SC 100 mg administered at Weeks 24, 28, 36, and 44. At Week 16, subjects who met the EE criteria received guselkumab at Week 16 and 20, then guselkumab q8w.
    Arm type
    		 Experimental

    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 at pre-specified timepoints.

    Number of subjects in period 1
    		Group 1: Guselkumab 100 mg q8w Group 2: Placebo
    Started
    189
    96
    EE at Week 16
    39 [1]
    45 [2]
    Crossover at Week 24
    0 [3]
    51 [4]
    Continuing GUS at Week 24-56
    174
    0 [5]
    Completed
    167
    83
    Not completed
    22
    13
         Consent withdrawn by subject
    5
    3
         Adverse event, non-fatal
    7
    3
         Unspecified
    3
    1
         Lost to follow-up
    1
    1
         Initiated prohibited medications
    1
    2
         Lack of efficacy
    5
    3
    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: There were only specified number of subjects in each arm of each milestone.
    [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: There were only specified number of subjects in each arm of each milestone.
    [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: There were only specified number of subjects in each arm of each milestone.
    [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: There were only specified number of subjects in each arm of each milestone.
    [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: There were only specified number of subjects in each arm of each milestone.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Guselkumab 100 mg q8w
    Reporting group description
    		 Subjects received GUS (guselkumab) 100 milligrams (mg) subcutaneously (SC) at Weeks 0 and 4, then every 8 weeks 12, 20, 28, 36, through Week (Wk) 44 with placebo SC administered at Week 24. At Week 16, subjects who met the early escape (EE) criteria received placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Subjects received placebo subcutaneously (SC) at Weeks 0, 4, 12, and 20 and crossed over at Week 24 to guselkumab SC 100 mg administered at Weeks 24, 28, 36, and 44. At Week 16, subjects who met the EE criteria received guselkumab at Week 16 and 20, then guselkumab q8w.

    Reporting group values
    		 Group 1: Guselkumab 100 mg q8w Group 2: Placebo Total
    Number of subjects
    		 189 96 285
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 169 89 258
        From 65 to 84 years
    		 20 7 27
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.1 ( 12.31 ) 49.1 ( 12.14 ) -
    Title for Gender
    Units: subjects
        Female
    		 103 44 147
        Male
    		 86 52 138

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Guselkumab 100 mg q8w
    Reporting group description
    		 Subjects received GUS (guselkumab) 100 milligrams (mg) subcutaneously (SC) at Weeks 0 and 4, then every 8 weeks 12, 20, 28, 36, through Week (Wk) 44 with placebo SC administered at Week 24. At Week 16, subjects who met the early escape (EE) criteria received placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).

    Reporting group title
    Group 2: Placebo
    Reporting group description
    		 Subjects received placebo subcutaneously (SC) at Weeks 0, 4, 12, and 20 and crossed over at Week 24 to guselkumab SC 100 mg administered at Weeks 24, 28, 36, and 44. At Week 16, subjects who met the EE criteria received guselkumab at Week 16 and 20, then guselkumab q8w.

    Primary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

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    End point title
    		 Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
    End point description
    ACR 20 response is defined as greater than or equal to (>=)20 percent (%) improvement from baseline in tender joint count (68 joints) and swollen joint count (66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain Visual Analog Scale (VAS) 0-100 millimeter(mm) scale, 0=no pain to 100=worst possible pain, Subject’s global assessment of disease activity (VAS)(scale, 0=Excellent to 100=poor), Physician’s global assessment of disease activity (VAS) (scale, 0=no arthritis activity to 100=extremely active arthritis),Subject’s assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale, 0=no difficulty to 3=inability to do task in that area), Serum C-reactive protein (CRP). Full Analysis Set 1 (FAS1) included all randomized subjects who received at least 1 dose (complete or partial) of study intervention. Subjects set to non-responders if they met treatment failure (TF) or had data missing.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Group 1: Guselkumab 100 mg q8w Group 2: Placebo
    Number of subjects analysed
    189
    96
    Units: percentage of subjects
        number (not applicable)
    44.4
    19.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Group 1: Guselkumab 100 mg q8w v Group 2: Placebo
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 % difference
    Point estimate
    24.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.1
         upper limit
    		 35.2

    Secondary: Change from Baseline in HAQ-DI Score at Week 24

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    End point title
    		 Change from Baseline in HAQ-DI Score at Week 24
    End point description
    The HAQ-DI measures the functional status of subjects scored on a scale of 0 to 3, with lower scores indicating better physical functioning. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. FAS1 included all randomized subjects who received at least 1 dose (complete or partial) of study intervention. Subjects set to non-responders if they met TF or had missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Group 1: Guselkumab 100 mg q8w Group 2: Placebo
    Number of subjects analysed
    189
    96
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -0.178 (-0.269 to -0.086)
    -0.009 (-0.120 to 0.102)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Group 1: Guselkumab 100 mg q8w v Group 2: Placebo
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Mixed model for repeated measures
    Parameter type
    		 LS mean Difference
    Point estimate
    -0.169
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.279
         upper limit
    		 -0.059

    Secondary: Percentage of Subjects who Achieved an ACR 50 Response at Week 24

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    End point title
    		 Percentage of Subjects who Achieved an ACR 50 Response at Week 24
    End point description
    ACR 50 response is defined as >=50% improvement from baseline in tender joint count (68 joints) and swollen joint count (66 joints) and in 3 of following 5 assessments: Subject’s assessment of pain (VAS) 0-100mm scale, 0=no pain to 100=worst possible pain, Subject’s global assessment of disease activity (VAS) (scale, 0=Excellent to 100=poor), Physician’s global assessment of disease activity (VAS) (scale, 0=no arthritis activity to 100=extremely active arthritis), Subject’s assessment of physical function as measured by HAQ-DI (scale, 0=no difficulty to 3=inability to do task in that area), CRP. FAS1 included all randomized subjects who received at least 1 dose (complete or partial) of study intervention. Subjects set to non-responders if they met TF or had missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Group 1: Guselkumab 100 mg q8w Group 2: Placebo
    Number of subjects analysed
    189
    96
    Units: percentage of subjects
        number (not applicable)
    19.6
    5.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Group 1: Guselkumab 100 mg q8w v Group 2: Placebo
    Number of subjects included in analysis
    285
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 % difference
    Point estimate
    14.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.2
         upper limit
    		 21.4

    Secondary: Change from Baseline in Physical Component Summary Scores (PCS) of the in 36-Item Short form Health Survey (SF-36) Score at Week 24

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    End point title
    		 Change from Baseline in Physical Component Summary Scores (PCS) of the in 36-Item Short form Health Survey (SF-36) Score at Week 24
    End point description
    The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state. FAS1 included all randomized subjects who received at least 1 dose (complete or partial) of study intervention. Subjects set to non-responders if they met TF or had missing data. Here 'n' (number analyzed) included all subjects who were analyzed at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Group 1: Guselkumab 100 mg q8w Group 2: Placebo
    Number of subjects analysed
    188
    96
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    3.514 (2.314 to 4.715)
    -0.387 (-1.841 to 1.067)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Group 1: Guselkumab 100 mg q8w v Group 2: Placebo
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed model for repeated measures (MMRM)
    Parameter type
    		 LS mean difference
    Point estimate
    3.901
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.457
         upper limit
    		 5.346

    Secondary: Percentage of Subjects who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Subjects with >=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of >=2 (Mild) at Baseline

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    End point title
    		 Percentage of Subjects who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Subjects with >=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of >=2 (Mild) at Baseline
    End point description
    The PASI is a system used for assessing and grading severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). PASI 100 response is defined as 100 percent (%) improvement in PASI score from baseline. Population analyzed included FAS1 among the subjects who had >=3% body surface area (BSA) of Psoriatic involvement and an IGA Score >=2 (mild) at baseline. Subjects set to non-responders if they met TF or had missing data. Here 'n' (number analyzed) included all subjects who were analyzed at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Group 1: Guselkumab 100 mg q8w Group 2: Placebo
    Number of subjects analysed
    133
    53
    Units: percentage of subjects
        number (not applicable)
    30.8
    3.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Group 1: Guselkumab 100 mg q8w v Group 2: Placebo
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 % difference
    Point estimate
    27.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.9
         upper limit
    		 36.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 56
    Adverse event reporting additional description
    The Safety Analysis Set 2 (SAS2) included all subjects who received at least 1 (complete or partial) dose of guselkumab from Week 0 to Week 56.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo Early Escape crossover to Guselkumab at Week 16
    Reporting group description
    		 Subjects received placebo and switched to guselkumab treatment at Week 16 (Early Escape Route), from the date of the first guselkumab administration up to End of Study (Week 56).

    Reporting group title
    Placebo No Early Escape crossover to Guselkumab at Week 24
    Reporting group description
    		 Subjects received placebo and switched to guselkumab treatment at Week 24, from the date of the first guselkumab administration up to End of Study (Week 56).

    Reporting group title
    Randomized to Guselkumab Week 0 to Week 24
    Reporting group description
    		 Subjects randomized to guselkumab treatment, from the date of the first guselkumab administration up to (but not including) the date of the Week 24 visit.

    Reporting group title
    Randomized to Guselkumab Week 24 to Week 56
    Reporting group description
    		 Subjects randomized to guselkumab treatment, starting at the date of the Week 24 visit up to end of study (Week 56).

    Reporting group title
    Guselkumab Combined
    Reporting group description
    		 Subjects received at least 1 dose of guselkumab including those randomized to receive guselkumab at Week 0, those who switched to guselkumab treatment at Week 16, and those who switched to guselkumab treatment at Week 24.

    Serious adverse events
    		 Placebo Early Escape crossover to Guselkumab at Week 16 Placebo No Early Escape crossover to Guselkumab at Week 24 Randomized to Guselkumab Week 0 to Week 24 Randomized to Guselkumab Week 24 to Week 56 Guselkumab Combined
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 45 (4.44%)
    2 / 45 (4.44%)
    7 / 189 (3.70%)
    5 / 174 (2.87%)
    15 / 279 (5.38%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 189 (0.53%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 45 (2.22%)
    0 / 189 (0.00%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate Cancer
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 189 (0.53%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Buttock Injury
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 189 (0.00%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 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
    Vascular disorders
    Varicose Vein
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 189 (0.00%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 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
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 189 (0.00%)
    1 / 174 (0.57%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 189 (0.00%)
    1 / 174 (0.57%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Lumbosacral Radiculopathy
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 189 (0.53%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 189 (0.00%)
    1 / 174 (0.57%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 189 (0.00%)
    1 / 174 (0.57%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Conversion Disorder
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 189 (0.53%)
    1 / 174 (0.57%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 189 (0.53%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 189 (0.53%)
    0 / 174 (0.00%)
    1 / 279 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 45 (2.22%)
    1 / 189 (0.53%)
    0 / 174 (0.00%)
    2 / 279 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         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 Early Escape crossover to Guselkumab at Week 16 Placebo No Early Escape crossover to Guselkumab at Week 24 Randomized to Guselkumab Week 0 to Week 24 Randomized to Guselkumab Week 24 to Week 56 Guselkumab Combined
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 45 (6.67%)
    3 / 45 (6.67%)
    14 / 189 (7.41%)
    8 / 174 (4.60%)
    26 / 279 (9.32%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 45 (6.67%)
    4 / 189 (2.12%)
    3 / 174 (1.72%)
    10 / 279 (3.58%)
         occurrences all number
    1
    5
    4
    3
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 45 (0.00%)
    10 / 189 (5.29%)
    5 / 174 (2.87%)
    16 / 279 (5.73%)
         occurrences all number
    2
    0
    10
    5
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2019
    It was implemented to clarify the definition of the Safety Analysis Set, to indicate that nominal, unadjusted analyses could be done for major secondary endpoints, to indicate that biomarker sampling at screening was optional, and to add clarity to the timing of certain assessments relative to dosing.
    28 Apr 2020
    It was implemented to provide guidance on study conduct and assessments during the Coronavirus Disease-2019 (COVID-19) pandemic. This amendment secured the possibility of SC injections of study intervention to be self-administered or be given by a caregiver/healthcare provider professional/site staff outside a study-site after Week 24, in cases where a site visit was not possible in view of national, regional or local restrictions.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    20 subjects were incorrectly routed to early escape (EE) at Week 16. Supplementary analysis 1 was done regardless of treatment used at that time-point and included all subjects in placebo group,even if they switched to guselkumab at Week 16 or not.
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    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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