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    Clinical Trial Results:
    A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis

    Summary
    EudraCT number
    2011-005634-19
    Trial protocol
    HU   EE   CZ   ES   DE   BG   PL  
    Global end of trial date
    29 Jan 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    10 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CD-IA-CAM-3001-1071
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01706926
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Marius Albulescu, Associate Medical Director, MedImmune, LLC, albulescum@medimmune.com
    Scientific contact
    Marius Albulescu, Associate Medical Director, MedImmune, LLC, albulescum@medimmune.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
    29 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 3 subcutaneous (SC) doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in participants with moderate-to-severe adult onset Rheumatoid Arthritis (RA).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Aug 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 31
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    Chile: 37
    Country: Number of subjects enrolled
    Colombia: 17
    Country: Number of subjects enrolled
    Czech Republic: 53
    Country: Number of subjects enrolled
    Estonia: 23
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Russian Federation: 33
    Country: Number of subjects enrolled
    Serbia: 24
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Ukraine: 43
    Worldwide total number of subjects
    326
    EEA total number of subjects
    139
    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)
    288
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 420 participants were screened out of which 326 participants were randomized and received investigational product in the study.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo matched to mavrilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.

    Arm title
    Mavrilimumab 30 mg
    Arm description
    Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Arm type
    Experimental

    Investigational medicinal product name
    Mavrilimumab 30 mg
    Investigational medicinal product code
    CAM-3001
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Arm title
    Mavrilimumab 100 mg
    Arm description
    Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Arm type
    Experimental

    Investigational medicinal product name
    Mavrilimumab 100 mg
    Investigational medicinal product code
    CAM-3001
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Arm title
    Mavrilimumab 150 mg
    Arm description
    Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
    Arm type
    Experimental

    Investigational medicinal product name
    Mavrilimumab 150 mg
    Investigational medicinal product code
    CAM-3001
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Number of subjects in period 1
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Started
    81
    81
    85
    79
    Completed
    75
    77
    79
    74
    Not completed
    6
    4
    6
    5
         Unspecified
    4
    4
    4
    3
         Consent withdrawn by subject
    2
    -
    1
    2
         Lost to follow-up
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.

    Reporting group title
    Mavrilimumab 30 mg
    Reporting group description
    Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Reporting group title
    Mavrilimumab 100 mg
    Reporting group description
    Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Reporting group title
    Mavrilimumab 150 mg
    Reporting group description
    Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Reporting group values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg Total
    Number of subjects
    81 81 85 79 326
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    52.8 ± 10.6 51.2 ± 11.6 50.8 ± 11.9 52.6 ± 10.3 -
    Gender, Male/Female
    Units: participants
        Female
    75 70 70 67 282
        Male
    6 11 15 12 44

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.

    Reporting group title
    Mavrilimumab 30 mg
    Reporting group description
    Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Reporting group title
    Mavrilimumab 100 mg
    Reporting group description
    Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Reporting group title
    Mavrilimumab 150 mg
    Reporting group description
    Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

    Primary: Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85

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    End point title
    Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85
    End point description
    DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Primary
    End point timeframe
    Baseline and Day 85
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline (n=81, 81, 85, 79)
    5.78 ± 0.09
    5.73 ± 0.104
    5.91 ± 0.096
    5.67 ± 0.086
        Change at Day 85 (n=77, 76, 79, 78)
    -0.68 ± 0.136
    -1.37 ± 0.136
    -1.64 ± 0.132
    -1.9 ± 0.136
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -0.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.06
         upper limit
    -0.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.193
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.33
         upper limit
    -0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -1.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    -0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.193

    Primary: Percentage of Participants who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169

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    End point title
    Percentage of Participants who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169
    End point description
    ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Primary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    24.7
    50.6
    61.2
    73.4
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    25.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.5
         upper limit
    40.3
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    36.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.5
         upper limit
    50.5
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    48.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.2
         upper limit
    62.3

    Secondary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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    End point title
    Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state. The safety population included all participants who received any dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
    number (not applicable)
        TEAEs
    46.9
    50.6
    42.4
    54.4
        TESAEs
    1.2
    4.9
    5.9
    2.5
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Number of Participants with Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
    End point description
    Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis. The safety population included all participants who received any dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: participants
        Anemia
    1
    1
    0
    0
        Eosinophilia
    0
    0
    1
    0
        Leukocytosis
    2
    0
    0
    0
        Lymphopenia
    0
    0
    0
    1
        Neutropenia
    1
    0
    0
    3
        Alanine aminotransferase increased
    0
    1
    1
    1
        Aspartate aminotransferase increased
    0
    1
    1
    0
        Gamma-glutamyltransferase increased
    0
    1
    0
    0
        Hypertransaminasaemia
    0
    0
    2
    2
        Dislipidaemia
    0
    0
    1
    0
        Hypercholesterolaemia
    1
    0
    1
    0
        Hyperlipidaemia
    0
    2
    0
    3
        Hyperkalaemia
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
    End point description
    Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported. The safety population included all participants who received any dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: participants
        Hypertension
    2
    4
    4
    3
        Weight increased
    1
    1
    1
    0
        Pyrexia
    0
    1
    0
    0
        Hot flush
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169

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    End point title
    Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169
    End point description
    Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the 6 second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15%, more than (>) 15 to =<20%, and >20%. The safety population included all participants who received any dose of investigational product. Here "n" signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percent of pulmonary test values
    number (not applicable)
        FEV1 =<15% (n=42,67,75,75)
    97.6
    98.5
    96
    89.3
        FEV1 >15 to 20% (n=42,67,75,75)
    0
    0
    1.3
    6.7
        FEV1 >20% (n=42,67,75,75)
    2.4
    1.5
    2.7
    4
        FEV6 =<15% (n=41,66,71,68)
    97.6
    97
    94.4
    89.7
        FEV6 >15 to 20% (n=41,66,71,68)
    0
    1.5
    1.4
    1.5
        FEV6 >20% (n=41,66,71,68)
    2.4
    1.5
    4.2
    8.8
        FVC =<15% (n=42,67,75,75)
    97.6
    98.5
    94.7
    94.7
        FVC >15 to 20% (n=42,67,75,75)
    0
    0
    1.3
    2.7
        FVC >20% (n=42,67,75,75)
    2.4
    1.5
    4
    2.7
    No statistical analyses for this end point

    Secondary: Dyspnea Score at Day 169

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    End point title
    Dyspnea Score at Day 169
    End point description
    Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The safety population included all participants who received any dose of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    41
    65
    73
    74
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.38 ± 0.62
    0.22 ± 0.54
    0.32 ± 0.73
    0.28 ± 0.64
    No statistical analyses for this end point

    Secondary: Oxygen Saturation Level at Day 169

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    End point title
    Oxygen Saturation Level at Day 169
    End point description
    Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. The safety population included all participants who received any dose of investigational product. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    40
    65
    73
    74
    Units: percent saturation
        arithmetic mean (standard deviation)
    97.4 ± 1.4
    97.4 ± 1.1
    97.4 ± 1.1
    97.3 ± 1.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169

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    End point title
    Percentage of Participants who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169
    End point description
    ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    12.3
    28.4
    25.9
    40.5
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.013
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.9
         upper limit
    28.2
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.03
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    13.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.8
         upper limit
    25.3
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    28.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.2
         upper limit
    41.1

    Secondary: Percentage of Participants who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169

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    End point title
    Percentage of Participants who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169
    End point description
    ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    3.7
    12.3
    10.6
    13.9
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.079
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    8.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.4
         upper limit
    16.9
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.133
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    6.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    14.6
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.026
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    10.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.5
         upper limit
    18.9

    Secondary: American College of Rheumatology (ACRn) Score at Day 169

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    End point title
    American College of Rheumatology (ACRn) Score at Day 169
    End point description
    ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: units on a scale
        arithmetic mean (standard error)
    13.25 ± 4.63
    29.04 ± 3.828
    30.24 ± 3.623
    40.72 ± 3.644
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.009
    Method
    Repeated measures model
    Parameter type
    Adjusted Mean difference
    Point estimate
    15.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.96
         upper limit
    27.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.007
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.004
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    16.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.42
         upper limit
    28.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.879
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    27.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.87
         upper limit
    39.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.892

    Secondary: Percentage of Participants who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169

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    End point title
    Percentage of Participants who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169
    End point description
    DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
    number (not applicable)
        No response
    65.4
    30.9
    28.2
    19
        Moderate response
    25.9
    35.8
    40
    41.8
        Good response
    8.6
    33.3
    31.8
    39.2
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Proportional odds analysis
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.56
         upper limit
    8.8
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Proportional odds analysis
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.64
         upper limit
    8.92
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Proportional odds analysis
    Parameter type
    Odds ratio (OR)
    Point estimate
    7.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.85
         upper limit
    13.4

    Secondary: Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169

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    End point title
    Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169
    End point description
    DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
    number (not applicable)
        DAS28 (CRP) Remission
    4.9
    21
    17.6
    19
        Low Disease Activity
    8.6
    33.3
    31.8
    41.8
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.004
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6
         upper limit
    26.1
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.014
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    12.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.3
         upper limit
    22.1
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.007
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.2
         upper limit
    23.9
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    The analysis reported DAS28 (CRP) low disease activity response.
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    24.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.7
         upper limit
    36.6
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    The analysis reported DAS28 (CRP) low disease activity response.
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    23.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.5
         upper limit
    34.8
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    The analysis reported DAS28 (CRP) low disease activity response.
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Percent difference
    Point estimate
    33.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.7
         upper limit
    45.6

    Secondary: Mean Change From Baseline in Swollen and Tender Joint Count at Day 169

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    End point title
    Mean Change From Baseline in Swollen and Tender Joint Count at Day 169
    End point description
    Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: joint count
    arithmetic mean (standard error)
        SJC: Baseline (n=81,81,85,79)
    14.44 ± 0.765
    17.8 ± 1.126
    16.82 ± 0.93
    15.72 ± 0.795
        SJC: Change at Day 169 (n=40,65,73,74)
    -4.97 ± 0.932
    -10.65 ± 0.809
    -11.18 ± 0.771
    -11.96 ± 0.787
        TJC: Baseline (n=81,81,85,79)
    26.26 ± 1.25
    27.48 ± 1.553
    26.96 ± 1.544
    26.7 ± 1.284
        TJC: Change at Day 169 (n=40,65,73,74)
    -7.9 ± 1.447
    -15.14 ± 1.265
    -16.35 ± 1.207
    -18.32 ± 1.234
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Analysis reported for change from baseline in swollen joint count at Day 169.
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -5.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.12
         upper limit
    -3.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.237
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Analysis reported for change from baseline in swollen joint count at Day 169.
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -6.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.6
         upper limit
    -3.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.211
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Analysis reported for change from baseline in swollen joint count at Day 169.
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.4
         upper limit
    -4.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.219
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Analysis reported for change from baseline in tender joint count at Day 169.
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -7.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.02
         upper limit
    -3.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.922
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    Analysis reported for change from baseline in tender joint count at Day 169.
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -8.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.16
         upper limit
    -4.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.884
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    Analysis reported for change from baseline in tender joint count at Day 169.
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -10.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.17
         upper limit
    -6.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.901

    Secondary: Mean Change From Baseline in Patient Assessment of Pain at Day 169

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    End point title
    Mean Change From Baseline in Patient Assessment of Pain at Day 169
    End point description
    Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: mm
    arithmetic mean (standard error)
        Baseline (n=81, 81, 85, 79)
    62.16 ± 2.093
    62.65 ± 2.11
    63.58 ± 2.034
    62.35 ± 2.217
        Change at Day 169 (n=40, 65, 73, 74)
    -15.2 ± 3.006
    -23.14 ± 2.563
    -23.31 ± 2.446
    -26.53 ± 2.483
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.045
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -7.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.72
         upper limit
    -0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.95
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.004
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -11.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19
         upper limit
    -3.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.899
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.037
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -8.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.73
         upper limit
    -0.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.876

    Secondary: Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169

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    End point title
    Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169
    End point description
    Participants responded to a question, "Considering all the ways your arthritis affects you, how are you feeling today?" by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: mm
    arithmetic mean (standard error)
        Baseline (n=81, 81, 85, 79)
    64.86 ± 1.892
    63.79 ± 2.074
    63.71 ± 1.957
    62.39 ± 2.099
        Change at Day 169 (n=40, 65, 73, 74)
    -20.21 ± 3.148
    -21.06 ± 2.685
    -22.4 ± 2.56
    -25.69 ± 2.6
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.837
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -0.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.99
         upper limit
    7.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.137
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.589
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -2.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.18
         upper limit
    5.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.058
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.18
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -5.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.52
         upper limit
    2.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.083

    Secondary: Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169

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    End point title
    Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169
    End point description
    Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: cm
    arithmetic mean (standard error)
        Baseline (n=81, 81, 85, 79)
    6.6 ± 0.168
    6.6 ± 0.162
    6.81 ± 0.144
    6.42 ± 0.166
        Change at Day 169 (n=40, 65, 73, 74)
    -2.39 ± 0.305
    -3.81 ± 0.254
    -3.85 ± 0.241
    -3.95 ± 0.243
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -1.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    -0.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.397
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -1.46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.23
         upper limit
    -0.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.389
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -1.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.33
         upper limit
    -0.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.391

    Secondary: Mean Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169

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    End point title
    Mean Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169
    End point description
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline (n=81, 80, 85, 79)
    1.63 ± 0.054
    1.52 ± 0.07
    1.58 ± 0.056
    1.58 ± 0.059
        Change at Day 169 (n=40, 65, 73, 74)
    -0.29 ± 0.081
    -0.37 ± 0.072
    -0.46 ± 0.068
    -0.55 ± 0.069
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.479
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.29
         upper limit
    0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.108
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.124
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -0.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.37
         upper limit
    0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.106
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.017
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    -0.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    -0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.107

    Secondary: Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169

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    End point title
    Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169
    End point description
    CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    38
    63
    72
    74
    Units: ratio
        geometric mean (geometric coefficient of variation)
    1.2971 ± 83.3
    0.8784 ± 102.8
    0.5197 ± 287.4
    0.5856 ± 153.3
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.017
    Method
    Repeated measures model
    Parameter type
    Adjusted geometric mean ratio
    Point estimate
    0.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    0.92
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted geometric mean ratio
    Point estimate
    0.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.31
         upper limit
    0.63
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted geometric mean ratio
    Point estimate
    0.46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.32
         upper limit
    0.66

    Secondary: Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169

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    End point title
    Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169
    End point description
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "N" (Number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    40
    64
    73
    74
    Units: ratio
        geometric mean (geometric coefficient of variation)
    0.89 ± 57
    0.67 ± 56.4
    0.62 ± 55.3
    0.58 ± 61
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.003
    Method
    Repeated measures model
    Parameter type
    Adjusted geometric mean ratio
    Point estimate
    0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    0.89
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted geometric mean ratio
    Point estimate
    0.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.55
         upper limit
    0.84
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Repeated measures model
    Parameter type
    Adjusted geometric mean ratio
    Point estimate
    0.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.49
         upper limit
    0.75

    Secondary: Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169

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    End point title
    Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169
    End point description
    The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    1.2
    6.2
    2.4
    5.1
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.21
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    4.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    10.7
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 1
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    5.1
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.207
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    3.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    9.2

    Secondary: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169

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    End point title
    Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169
    End point description
    The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    1.2
    6.2
    3.5
    7.6
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.21
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    4.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    10.7
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.621
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    6.9
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.062
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    6.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    12.7

    Secondary: Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169

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    End point title
    Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169
    End point description
    ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.
    End point type
    Secondary
    End point timeframe
    Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    0
    3.7
    1.2
    1.3
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.245
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    7.8
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 1
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    3.5
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.494
    Method
    Fisher exact
    Parameter type
    Percent difference
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.2
         upper limit
    3.7

    Secondary: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169

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    End point title
    Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169
    End point description
    FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue. The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here "n" signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: units on a scale
    arithmetic mean (standard error)
        Baseline (n=79, 80, 84, 79)
    26.75 ± 0.824
    28.91 ± 1.078
    28.45 ± 0.998
    27.82 ± 0.95
        Change at Day 169 (n=40, 65, 73, 74)
    4.53 ± 1.225
    5.72 ± 1.039
    6.8 ± 0.988
    8.45 ± 0.997
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo v Mavrilimumab 30 mg
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.463
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    1.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.99
         upper limit
    4.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.608
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v Mavrilimumab 100 mg
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.151
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    2.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.83
         upper limit
    5.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.574
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo v Mavrilimumab 150 mg
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.014
    Method
    Repeated measures model
    Parameter type
    Adjusted mean difference
    Point estimate
    3.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    7.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.578

    Secondary: Serum Concentrations of Mavrilimumab

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    End point title
    Serum Concentrations of Mavrilimumab [1]
    End point description
    Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). In the below table, '99999' indicates data was not reported for the geometric coefficient of variation for the respective timepoint. The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here "n" signifies participants who were evaluable for the specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 8, 15, 29, 85, 141, and 169
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo-treated subjects (N=81) were excluded from the pharmacokinetic analysis.
    End point values
    Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    85
    79
    Units: nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Baseline (n=80, 85, 79)
    0 ± 894.4
    0 ± 99999
    0 ± 862
        Day 8 (n=78, 83, 78)
    617.49 ± 111.8
    3563.31 ± 49.3
    6087.06 ± 43.4
        Day 15 (n=78, 84, 78)
    154.6 ± 194.2
    2479.96 ± 52.1
    4616.35 ± 42.6
        Day 29 (n=77, 85, 76)
    217.67 ± 248.3
    4503.97 ± 54.8
    7843.66 ± 42.9
        Day 85 (n=74, 81, 77)
    201.57 ± 162.8
    6538.22 ± 52.7
    13213.93 ± 50.1
        Day 141 (n=67, 75, 71)
    258.77 ± 136.9
    2932.8 ± 75.6
    9241.31 ± 52.1
        Day 169 (n=63, 73, 74)
    348.97 ± 141.2
    5282.37 ± 62
    9178.47 ± 56.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at any Visit

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    End point title
    Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at any Visit
    End point description
    Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays. The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 169
    End point values
    Placebo Mavrilimumab 30 mg Mavrilimumab 100 mg Mavrilimumab 150 mg
    Number of subjects analysed
    81
    81
    85
    79
    Units: percentage of participants
        number (not applicable)
    2.5
    16
    3.5
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 169
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    PLACEBO
    Reporting group description
    -

    Reporting group title
    MAVRILIMUMAB 100MG
    Reporting group description
    -

    Reporting group title
    MAVRILIMUMAB 150MG
    Reporting group description
    -

    Reporting group title
    MAVRILIMUMAB 30MG
    Reporting group description
    -

    Serious adverse events
    PLACEBO MAVRILIMUMAB 100MG MAVRILIMUMAB 150MG MAVRILIMUMAB 30MG
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 81 (1.23%)
    5 / 85 (5.88%)
    2 / 79 (2.53%)
    4 / 81 (4.94%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of the cervix
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial tachycardia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    PLACEBO MAVRILIMUMAB 100MG MAVRILIMUMAB 150MG MAVRILIMUMAB 30MG
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 81 (46.91%)
    33 / 85 (38.82%)
    42 / 79 (53.16%)
    38 / 81 (46.91%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    2 / 81 (2.47%)
    4 / 85 (4.71%)
    3 / 79 (3.80%)
    4 / 81 (4.94%)
         occurrences all number
    2
    5
    3
    4
    Venous insufficiency
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    2 / 79 (2.53%)
    1 / 81 (1.23%)
         occurrences all number
    1
    0
    2
    1
    Hypersensitivity
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    1
    Injection site erythema
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injection site swelling
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         occurrences all number
    1
    0
    2
    2
    Injection site reaction
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    2 / 81 (2.47%)
         occurrences all number
    0
    0
    1
    2
    Dyssomnia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endometriosis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Uterine polyp
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Animal bite
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Bone contusion
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chemical poisoning
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Clavicle fracture
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Contusion
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Epicondylitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injection related reaction
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Laceration
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Limb injury
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Muscle contusion
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Weight increased
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    1
    1
    0
    1
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac failure
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchospasm
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pleural effusion
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    1
    0
    0
    1
    Eosinophilia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    3 / 79 (3.80%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 81 (2.47%)
    4 / 85 (4.71%)
    6 / 79 (7.59%)
    5 / 81 (6.17%)
         occurrences all number
    2
    4
    8
    5
    Intercostal neuralgia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Keratitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 79 (2.53%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    2
    1
    Dyspepsia
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 79 (2.53%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gingival swelling
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mouth cyst
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal colic
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 85 (2.35%)
    2 / 79 (2.53%)
    0 / 81 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intertrigo
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 79 (2.53%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rash
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    4 / 81 (4.94%)
    2 / 85 (2.35%)
    0 / 79 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    6
    2
    0
    3
    Rheumatoid nodule
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    0
    1
    Sjogren's syndrome
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tendonitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    3 / 79 (3.80%)
    2 / 81 (2.47%)
         occurrences all number
    0
    0
    3
    2
    Infections and infestations
    Body tinea
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    6 / 81 (7.41%)
    1 / 85 (1.18%)
    4 / 79 (5.06%)
    3 / 81 (3.70%)
         occurrences all number
    6
    1
    4
    3
    Cystitis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 79 (2.53%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    2
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 81 (0.00%)
    3 / 85 (3.53%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         occurrences all number
    0
    3
    1
    1
    Lyme disease
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 81 (7.41%)
    3 / 85 (3.53%)
    6 / 79 (7.59%)
    4 / 81 (4.94%)
         occurrences all number
    6
    4
    6
    5
    Omphalitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Periodontitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    2 / 79 (2.53%)
    2 / 81 (2.47%)
         occurrences all number
    0
    0
    2
    2
    Sinusitis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tinea pedis
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 85 (0.00%)
    1 / 79 (1.27%)
    0 / 81 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 85 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    2 / 81 (2.47%)
         occurrences all number
    1
    1
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    2 / 81 (2.47%)
         occurrences all number
    0
    1
    1
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 85 (1.18%)
    1 / 79 (1.27%)
    2 / 81 (2.47%)
         occurrences all number
    1
    1
    1
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2010
    The anticipated number of study centers was increased from 90 to 100. The maximum duration of the study was corrected from 40 weeks to 44 weeks. Reference to the data safety monitoring board (DSMB) was removed from the Study-stopping Criteria section of the protocol. A section describing un-blinding in the event of a suspected unexpected serious adverse reaction (SUSAR) was added to the protocol. Language in the protocol was clarified to state that investigational product was not to be removed from the storage area until all protocol-specific assessments were completed and the subject was ready for dosing. Instructions relating to the preparation of placebo were added to the protocol. In the case of a clinically significant pulmonary abnormality, the language in the protocol was clarified to make it clear that the investigator was the responsible person, in collaboration with the sponsor, to make the decision to resume administration of investigational product. Changes in eligibility criteria. A diffusing capacity for carbon monoxide (DLCO) assessment was added to the protocol. The need for a sample collection for anti-drug antibodies (ADA) analysis in the event of a severe hypersensitivity reaction was removed from the protocol.

    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.
    Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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