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    Clinical Trial Results:
    An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Participants with Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2011-005648-93
    Trial protocol
    		 EE   HU   CZ   DE   ES   BG   GR   SK   PT   GB  
    Global end of trial date
    30 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2017
    First version publication date
    15 Mar 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CD-IA-CAM-3001-1109
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01712399
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC.
    Sponsor organisation address
    Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom,
    Public contact
    Marius Albulescu, MD, MedImmune, LLC., +44 (0) 301-398-0000, clinicaltrialenquiries@medimmune.com
    Scientific contact
    Marius Albulescu, MD, MedImmune, LLC., +44 (0) 301-398-0000, clinicaltrialenquiries@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
    30 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the long-term safety of mavrilimumab in adult participants with moderate-to-severe active Rheumatoid Arthritis (RA) who were previously treated in a qualifying study.
    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
    11 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Argentina: 41
    Country: Number of subjects enrolled
    Chile: 35
    Country: Number of subjects enrolled
    Colombia: 25
    Country: Number of subjects enrolled
    Czech Republic: 69
    Country: Number of subjects enrolled
    Estonia: 21
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Poland: 34
    Country: Number of subjects enrolled
    Russian Federation: 53
    Country: Number of subjects enrolled
    Serbia: 24
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Ukraine: 39
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    397
    EEA total number of subjects
    157
    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)
    354
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 409 participants consented and 397 participants received mavrilimumab in this study.

    Pre-assignment
    Screening details
    		 A total of 442 participants who received at least one dose of mavrilimumab provided a pooled analysis of safety and efficacy data from this open-label extension study (CD IA CAM 3001 1109) together with the qualifying studies (CD IA CAM 3001 1071 and CD IA CAM 3001 1107).

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

    Arms
    Arm title
    		 Mavrilimumab 100 mg
    Arm description
    		 Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mavrilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.

    Number of subjects in period 1
    		Mavrilimumab 100 mg
    Started
    397
    Completed
    0
    Not completed
    397
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    39
         Adverse event, non-fatal
    11
         Lost to follow-up
    1
         Study closure
    345

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mavrilimumab 100 mg
    Reporting group description
    		 Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.

    Reporting group values
    		 Mavrilimumab 100 mg Total
    Number of subjects
    		 397 397
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 354 354
        From 65-84 years
    		 43 43
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 51.1 ( 11.2 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 339 339
        Male
    		 58 58
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaskan Native
    		 29 29
        Asian
    		 1 1
        Black or African American
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        White
    		 364 364
        Other
    		 2 2
    Region of Enrollment
    Units: Subjects
        ARGENTINA
    		 41 41
        BULGARIA
    		 3 3
        CHILE
    		 35 35
        COLOMBIA
    		 25 25
        CZECH REPUBLIC
    		 69 69
        ESTONIA
    		 21 21
        GERMANY
    		 8 8
        GREECE
    		 3 3
        HUNGARY
    		 9 9
        ISRAEL
    		 11 11
        MEXICO
    		 10 10
        POLAND
    		 34 34
        RUSSIAN FEDERATION
    		 53 53
        SERBIA
    		 24 24
        SLOVAKIA
    		 1 1
        SOUTH AFRICA
    		 2 2
        SPAIN
    		 4 4
        UKRAINE
    		 39 39
        UNITED KINGDOM
    		 5 5
    Study Specific Characteristic | Weight
    Units: Kilogram
        arithmetic mean (standard deviation)
    		 73.25 ( 16.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    Mavrilimumab 100 mg
    Reporting group description
    		 Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of 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. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
    End point type
    Primary
    End point timeframe
    From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
        TEAEs
    288
        TESAEs
    46
    No statistical analyses for this end point

    Primary: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) [2]
    End point description
    Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
    End point type
    Primary
    End point timeframe
    From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
        Anaemia
    8
        Eosinophilia
    1
        Iron deficiency anaemia
    2
        Leukocytosis
    1
        Leukopenia
    1
        Lymphadenopathy
    1
        Neutropenia
    2
        Spontaneous haematoma
    1
        Alanine aminotransferase increased
    8
        Aspartate aminotransferase increased
    6
        Blood creatinine increased
    1
        Blood glucose increased
    1
        Blood pressure increased
    3
        C-reactive protein increased
    1
        Chest X-ray abnormal
    1
        Forced vital capacity abnormal
    1
        Gamma-glutamyltransferase increased
    2
        Hepatic enzyme increased
    2
        Liver function test abnormal
    1
        Mycobacterium tuberculosis complex test positive
    1
        Neutrophil count decreased
    1
        Red blood cell sedimentation rate increased
    1
        Transaminases increased
    3
        Diabetes mellitus
    5
        Dyslipidaemia
    4
        Hypercholesterolaemia
    9
        Hyperglycaemia
    3
        Hyperlipidaemia
    2
        Hypertriglyceridaemia
    2
        Hypoglycaemia
    1
        Type 2 diabetes mellitus
    4
    No statistical analyses for this end point

    Primary: Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) [3]
    End point description
    Vital sign assessments included blood pressure, pulse rate, temperature, weight, and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
    End point type
    Primary
    End point timeframe
    From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
        Hypertension
    26
        Pyrexia
    3
        Blood pressure increased
    3
        Atrial fibrillation
    1
        Palpitations
    1
        Sinus tachycardia
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs

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    End point title
    		 Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs [4]
    End point description
    The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
    End point type
    Primary
    End point timeframe
    From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values

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    End point title
    		 Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values [5]
    End point description
    Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
    End point type
    Primary
    End point timeframe
    From Week 24 to Week 130 at specified time points
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
        Week 24 (n=236):=<15% reduction
    208
        Week 24 (n=236):>15% to =<20%
    12
        Week 24 (n=236):>20% reduction
    16
        Week 24 (n=236):>20% to <80%
    13
        Week 48 (n=231):=<15% reduction
    208
        Week 48 (n=231): >15% to =<20%
    10
        Week 48 (n=231): >20% reduction
    13
        Week 48 (n=231):>20% to <80%
    8
        Week 78 (n=178):=<15% reduction
    154
        Week 78 (n=178):>15% to =<20%
    8
        Week 78 (n=178):>20% reduction
    16
        Week 78 (n=178):>20% to <80%
    11
        Week 104 (n=29):=<15% reduction
    28
        Week 104 (n=29):>15% to =<20%
    0
        Week 104 (n=29):>20% reduction
    1
        Week 104 (n=29):>20% to <80%
    1
        Week 130 (n=3):=<15% reduction
    3
        Week 130 (n=3):>15% to =<20%
    0
        Week 130 (n=3):>20% reduction
    0
        Week 130 (n=3):>20% to <80%
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values

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    End point title
    		 Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values [6]
    End point description
    Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
    End point type
    Primary
    End point timeframe
    From Week 24 to Week 130 at specified time points
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
        Week 24 (n=222):=<15% reduction
    195
        Week 24 (n=222):>15% to =<20%
    14
        Week 24 (n=222):>20% reduction
    13
        Week 24 (n=222):>20% to <80%
    9
        Week 48 (n=222):=<15% reduction
    201
        Week 48 (n=222):>15% to =<20%
    13
        Week 48 (n=222):>20% reduction
    8
        Week 48 (n=222):>20% to <80%
    4
        Week 78 (n=172):=<15% reduction
    150
        Week 78 (n=172):>15% to =<20%
    8
        Week 78 (n=172):>20% reduction
    14
        Week 78 (n=172):>20% to <80%
    5
        Week 104 (n=28):=<15% reduction
    27
        Week 104 (n=28):>15% to =<20%
    0
        Week 104 (n=28):>20% reduction
    1
        Week 104 (n=28):>20% to <80%
    1
        Week 130 (n=3):=<15% reduction
    1
        Week 130 (n=3):>15% to =<20%
    0
        Week 130 (n=3):>20% reduction
    2
        Week 130 (n=3):>20% to <80%
    2
    No statistical analyses for this end point

    Primary: Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values

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    End point title
    		 Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values [7]
    End point description
    Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). 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 decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
    End point type
    Primary
    End point timeframe
    From Week 24 to Week 156 at specified time points
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Participants
        Week 24 (n=233):=<15% reduction
    209
        Week 24 (n=233):>15% to =<20%
    13
        Week 24 (n=233):>20% reduction
    11
        Week 24 (n=233):>20% to <80%
    7
        Week 48 (n=239):=<15% reduction
    218
        Week 48 (n=239):>15% to =<20%
    10
        Week 48 (n=239):>20% reduction
    11
        Week 48 (n=239):>20% to <80%
    7
        Week 78 (n=177):=<15% reduction
    160
        Week 78 (n=177):>15% to =<20%
    4
        Week 78 (n=177):>20% reduction
    13
        Week 78 (n=177):>20% to <80%
    6
        Week 104 (n=32):=<15% reduction
    32
        Week 104 (n=32):>15% to =<20%
    0
        Week 104 (n=32):>20% reduction
    0
        Week 104 (n=32):>20% to <80%
    0
        Week 130 (n=5):=<15% reduction
    4
        Week 130 (n=5):>15% to =<20%
    0
        Week 130 (n=5):>20% reduction
    1
        Week 130 (n=5):>20% to <80%
    1
        Week 156 (n=2):=<15% reduction
    2
        Week 156 (n=2):>15% to =<20%
    0
        Week 156 (n=2):>20% reduction
    0
        Week 156 (n=2):>20% to <80%
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE

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    End point title
    		 Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE [8]
    End point description
    Borg dyspnea score was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
    End point type
    Primary
    End point timeframe
    From Week 0 to Week 132 at specified time points
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    394
    Units: Participants
    0
    No statistical analyses for this end point

    Primary: Oxygen Saturation Levels by Pulse Oximetry

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    End point title
    		 Oxygen Saturation Levels by Pulse Oximetry [9]
    End point description
    Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. 99999 indicates non-availability of data as standard error was not calculated due to limited sample size. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
    End point type
    Primary
    End point timeframe
    From Week 0 to Week 132 at specified time points
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: Percent saturation
    arithmetic mean (standard error)
        Week 0 (n=397)
    97.6 ( 0.1 )
        Week 12 (n=384)
    97.6 ( 0.1 )
        Week 24 (n=1)
    98 ( 99999 )
        Week 36 (n=357)
    97.5 ( 0.1 )
        Week 48 (n=327)
    97.8 ( 0.1 )
        Week 60 (n=281)
    97.8 ( 0.1 )
        Week 72 (n=233)
    97.7 ( 0.1 )
        Week 84 (n=222)
    97.7 ( 0.1 )
        Week 96 (n=188)
    97.9 ( 0.1 )
        Week 108 (n=58)
    97.8 ( 0.2 )
        Week 120 (n=18)
    97.6 ( 0.3 )
        Week 132 (n=7)
    97.9 ( 0.5 )
    No statistical analyses for this end point

    Primary: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

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    End point title
    		 Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [10]
    End point description
    DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide. The unit mL/min/mmHg refers to milliliter/minute/millimeter of mercury. The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.
    End point type
    Primary
    End point timeframe
    From Week 12 to Week 156 at specified time points
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Mavrilimumab 100 mg
    Number of subjects analysed
    397
    Units: mL/min/mmHg
    arithmetic mean (standard deviation)
        Week 12 (n=80)
    21.196 ( 5.158 )
        Week 24 (n=155)
    21.996 ( 5.274 )
        Week 48 (n=203)
    21.135 ( 4.873 )
        Week 78 (n=165)
    20.639 ( 4.637 )
        Week 104 (n=144)
    20.636 ( 5.088 )
        Week 130 (n=52)
    20.372 ( 4.546 )
        Week 156 (n=6)
    19.265 ( 4.131 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Mavrilimumab 100 mg
    Reporting group description
    		 Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.

    Serious adverse events
    		 Mavrilimumab 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 397 (11.59%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer female
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyogenic granuloma
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Subclavian artery thrombosis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Myelitis transverse
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 397 (0.76%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    4 / 397 (1.01%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendiceal abscess
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    4 / 397 (1.01%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyomyositis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    1 / 397 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 397 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Mavrilimumab 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    214 / 397 (53.90%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    8 / 397 (2.02%)
         occurrences all number
    8
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    8 / 397 (2.02%)
         occurrences all number
    8
    Vascular disorders
    Hypertension
         subjects affected / exposed
    26 / 397 (6.55%)
         occurrences all number
    27
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 397 (4.28%)
         occurrences all number
    35
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    8 / 397 (2.02%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    15 / 397 (3.78%)
         occurrences all number
    15
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 397 (2.02%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 397 (3.02%)
         occurrences all number
    13
    Osteoarthritis
         subjects affected / exposed
    12 / 397 (3.02%)
         occurrences all number
    13
    Rheumatoid arthritis
         subjects affected / exposed
    38 / 397 (9.57%)
         occurrences all number
    78
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    44 / 397 (11.08%)
         occurrences all number
    59
    Gastroenteritis
         subjects affected / exposed
    11 / 397 (2.77%)
         occurrences all number
    14
    Influenza
         subjects affected / exposed
    23 / 397 (5.79%)
         occurrences all number
    26
    Nasopharyngitis
         subjects affected / exposed
    59 / 397 (14.86%)
         occurrences all number
    90
    Oral herpes
         subjects affected / exposed
    11 / 397 (2.77%)
         occurrences all number
    13
    Pharyngitis
         subjects affected / exposed
    18 / 397 (4.53%)
         occurrences all number
    20
    Respiratory tract infection
         subjects affected / exposed
    13 / 397 (3.27%)
         occurrences all number
    21
    Rhinitis
         subjects affected / exposed
    9 / 397 (2.27%)
         occurrences all number
    10
    Upper respiratory tract infection
         subjects affected / exposed
    31 / 397 (7.81%)
         occurrences all number
    43
    Urinary tract infection
         subjects affected / exposed
    35 / 397 (8.82%)
         occurrences all number
    53
    Viral infection
         subjects affected / exposed
    8 / 397 (2.02%)
         occurrences all number
    10
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    9 / 397 (2.27%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2012
    Reference to the Data safety monitoring board (DSMB) was removed from the Study-stopping Criteria, Definition of the timing of the withdrawal visit was added, Withdrawal criteria item revised to include a definition of inadequate response, A section describing unblinding in the event of a suspected unexpected serious adverse reaction (SUSAR) was added, Responsibilities for the decision to resume administration of investigational product for a participant referred for a specialist pulmonary evaluation were clarified, A DLCO assessment was added, Reference to recording the QT interval during the electrocardiogram (ECG) was removed, Text describing an additional serum sample collection was added, The estimate of volume of blood to be collected was amended and Mention of flow cytometry was deleted from the exploratory endpoints and the protocol abstract

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Sep 2015
    The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations (the 100 mg Q2W dose was considered suboptimal compared with 150 mg Q2W based on CD-IA-CAM-3001-1071 data).
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations (the 100 mg Q2W dose was considered suboptimal compared with 150 mg Q2W based on CD-IA-CAM-3001-1071 data).
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