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    Clinical Trial Results:
    BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy

    Summary
    EudraCT number
    		 2012-000385-38
    Trial protocol
    		 GB  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    27 Apr 2016
    First version publication date
    28 May 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    BEL116472
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    Interim
    Date of interim/final analysis
    22 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Sep 2014
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is: To evaluate whether belimumab can modulate proteinuria in IMGN. To evaluate whether belimumab can modulate anti-PLA2R autoantibodies in patients with detectable baseline levels of these antibodies.
    Protection of trial subjects
    The protocol contains stopping criteria to protect trial participants as well as eligibility criteria to exclude participants who may not benefit. Eligibility criteria to protect participants include exclusion of those with infections, exclusion of participants with HIV, hepatitis B and hepatitis C, exclusion of participants with deteriorating or severely reduced renal function. Study specific stopping criteria include deteriorating renal function, deteriorating nephrotic state as assessed by increasing proteinuria and reduction in serum albumin, proteinuria without improvement, hypogammaglobulinaemia without improvement.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jul 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    13
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants (par.) were recruited into the initial 6 month treatment phase of this 2 part study from July 2012 until March 2014 in academic nephrology clinics. Results presented are for the initial treatment phase, up to the Week 28 primary endpoint.

    Pre-assignment
    Screening details
    		 Screening occurred within approximately 35 days and no less than 14 days before the first scheduled dose of study medication. A total of 21 participants were screened; 14 participants were randomized, and 14 participants entered the initial treatment period. Common reasons for screen failures were insufficient or improvements in proteinuria.

    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
    		 Belimumab 10 mg/kg IV
    Arm description
    		 Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for dispersion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/kg IV at weeks 0, 2, 4 then every 4 weeks for 2 years. Participants with >1000 mg/mmol proteinuria will remain on dosing every 2 weeks.

    Number of subjects in period 1
    		Belimumab 10 mg/kg IV
    Started
    14
    Completed
    11
    Not completed
    3
         Physician decision
    1
         Lack of efficacy
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Belimumab 10 mg/kg IV
    Reporting group description
    		 Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.

    Reporting group values
    		 Belimumab 10 mg/kg IV Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.1 ± 13.3 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 11 11
    Race
    Units: Subjects
        Asian - Central/South Asian Heritage
    		 4 4
        White
    		 9 9
        Missing
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Belimumab 10 mg/kg IV
    Reporting group description
    		 Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.

    Primary: Change from Baseline in proteinuria levels at Week 28

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    End point title
    		 Change from Baseline in proteinuria levels at Week 28 [1]
    End point description
    Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Intent-to-Treat (ITT) Population: all eligible participants who received at least one dose of investigational drug. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% CI=0.57 to 1.01. The geometric mean method was used to calculate the CI.
    End point type
    Primary
    End point timeframe
    Baseline and Week 28
    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: Due to the system not allowing entry of statistical information for 1 arm studies, a statistical statement was added to the outcome measure description.
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    11 [2]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    0.76 ± 45
    Notes
    [2] - ITT Population. Only those par. available at the indicated time point (Week 28) were analyzed.
    No statistical analyses for this end point

    Primary: Change from Baseline in anti-phospholipase A2 receptor (PLA2R) autoantibody titres at Week 28

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    End point title
    		 Change from Baseline in anti-phospholipase A2 receptor (PLA2R) autoantibody titres at Week 28 [3]
    End point description
    PLA2R autoantibody titres in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.25, 2-sided 95% CI=0.12 to 0.54. The geometric mean method was used to calculate the CI.
    End point type
    Primary
    End point timeframe
    Baseline and Week 28
    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: Due to the system not allowing entry of statistical information for 1 arm studies, a statistical statement was added to the outcome measure description.
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    11 [4]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    0.25 ± 167
    Notes
    [4] - ITT Population. Only those par. available at the indicated time point (Week 28) were analyzed.
    No statistical analyses for this end point

    Secondary: Proteinuria levels at the indicated time points

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    End point title
    		 Proteinuria levels at the indicated time points
    End point description
    Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 h urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 28
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    14 [5]
    Units: milligrams per millimole (mg/mmol)
    geometric mean (geometric coefficient of variation)
        Baseline, n=14
    724.3 ± 40.2
        Week 28, n=11
    498.1 ± 40.9
    Notes
    [5] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in proteinuria levels at the indicated time points

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    End point title
    		 Change from Baseline in proteinuria levels at the indicated time points
    End point description
    Proteinuria is being assessed at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and at the 16 week and 6 month follow-up visits. Proteinuria measurements are being based on urinary protein creatinine ratio measurements spot urine samples. For other key time points, Weeks 12, 52, 76 and 4 week post last dose, they are the mean of the PCR from a pre-dose spot urine sample and from a 24 h post-dose or post visit urine collection. Baseline is defined as the mean of the pre and post dosing Day 0 values from 2 consecutive 24 h urine collections. The ratio is defined as the post-Baseline value divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 28, 52, 76 and 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [6]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [6] - ITT Population
    No statistical analyses for this end point

    Secondary: Anti-phospholipase A2 receptor (PLA2R) autoantibody titres at the indicated time points

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    End point title
    		 Anti-phospholipase A2 receptor (PLA2R) autoantibody titres at the indicated time points
    End point description
    PLA2R autoantibody titres in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 28
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    14 [7]
    Units: relative units per milliliter (RU/mL)
    geometric mean (geometric coefficient of variation)
        Baseline, n=14
    168.3 ± 138.9
        Week 28, n=11
    43.6 ± 373.5
    Notes
    [7] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in anti-PLA2R autoantibody titres at the indicated time points

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    End point title
    		 Change from Baseline in anti-PLA2R autoantibody titres at the indicated time points
    End point description
    PLA2R autoantibody titres in serum are being analyzed by means of a validated anti- PLA2R ELISA from EuroImmun. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. Baseline is defined as the Day 0 value. Ratio is defined as the post-Baseline value divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 28, 52, 76 and 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [8]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in urine levels of belimumab at the indicated time points

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    End point title
    		 Change from Baseline in urine levels of belimumab at the indicated time points
    End point description
    24 h urine samples are being collected for pharmacokinetic analysis of belimumab, after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. Baseline is defined as the Day 0 value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 28, 52, 76 and 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [9]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [9] - ITT Population
    No statistical analyses for this end point

    Secondary: Incidence of complete or partial remission

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    End point title
    		 Incidence of complete or partial remission
    End point description
    Complete remission is defined as PCR <30 milligrams per millimoles (mg/mmol) (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent [%]). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no worsening in renal function (eGFR reduction from Baseline <15%). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [10]
    Units: Participants
    Notes
    [10] - ITT Population
    No statistical analyses for this end point

    Secondary: Time to complete or partial remission

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    End point title
    		 Time to complete or partial remission
    End point description
    Time to complete or partial remission and time of proteinuria are being estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15%). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no worsening in renal function (eGFR reduction from Baseline <15%). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [11]
    Units: Weeks
        median (full range (min-max))
    ( to )
    Notes
    [11] - ITT Population
    No statistical analyses for this end point

    Secondary: Duration of complete or partial remission

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    End point title
    		 Duration of complete or partial remission
    End point description
    Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15%). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no worsening in renal function (eGFR reduction from Baseline <15%). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/ 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [12]
    Units: Days
        arithmetic mean (standard deviation)
    ±
    Notes
    [12] - ITT Population
    No statistical analyses for this end point

    Secondary: Incidence of proteinuria relapse

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    End point title
    		 Incidence of proteinuria relapse
    End point description
    Incidence of proteinuria relapse is defined as participants with PCR >350 mg/mmol and an increase of 50% from the lowest remission level, in those participants who had previously achieved any type of remission. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [13]
    Units: Participants
    Notes
    [13] - ITT Population
    No statistical analyses for this end point

    Secondary: Incidence of full/partial remission for anti-PLA2R autoantibody

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    End point title
    		 Incidence of full/partial remission for anti-PLA2R autoantibody
    End point description
    Incidence of anti-PLA2R autoantibody remission: full response is defined as antibody undetectable, partial response is defined as reduction in titres by 50%. For anti PLA2R autoantibody data, log transformation is being applied before the formal analyses. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 Week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [14]
    Units: Participants
    Notes
    [14] - ITT Population
    No statistical analyses for this end point

    Secondary: Time to anti-PLA2R autoantibody remission

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    End point title
    		 Time to anti-PLA2R autoantibody remission
    End point description
    Time to anti-PLA2R autoantibody remission - full response with antibody undetectable. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [15]
    Units: Weeks
        median (full range (min-max))
    ( to )
    Notes
    [15] - ITT Population
    No statistical analyses for this end point

    Secondary: Incidence of anti-PLA2R autoantibody relapse

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    End point title
    		 Incidence of anti-PLA2R autoantibody relapse
    End point description
    Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [16]
    Units: Participants
    Notes
    [16] - ITT Population
    No statistical analyses for this end point

    Secondary: eGFR levels at the indicated time points

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    End point title
    		 eGFR levels at the indicated time points
    End point description
    eGFR is being assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), eGFR is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods. Milliliters per minute per 1.73 meter squared (ml/min/1.73m^2).
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [17]
    Units: ml/min/1.73m^2
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [17] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in eGFR levels at the indicated time points

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    End point title
    		 Change from Baseline in eGFR levels at the indicated time points
    End point description
    eGFR is being assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), eGFR is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [18]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [18] - ITT Population
    No statistical analyses for this end point

    Secondary: Serum creatinine levels at the indicated time points

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    End point title
    		 Serum creatinine levels at the indicated time points
    End point description
    Clinical chemistry laboratory parameters included serum creatinine which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum creatinine is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [19]
    Units: micromoles/liter (µmol/L)
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [19] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in serum creatinine levels at the indicated time points

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    End point title
    		 Change from Baseline in serum creatinine levels at the indicated time points
    End point description
    Clinical chemistry laboratory parameters included serum creatinine which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum creatinine is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [20]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [20] - ITT Population
    No statistical analyses for this end point

    Secondary: Serum albumin at the indicated time points

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    End point title
    		 Serum albumin at the indicated time points
    End point description
    Clinical chemistry laboratory parameters included serum albumin which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum albumin is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [21]
    Units: grams per liter (g/L)
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [21] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in levels of serum albumin at the indicated time points

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    End point title
    		 Change from Baseline in levels of serum albumin at the indicated time points
    End point description
    Clinical chemistry laboratory parameters included serum albumin which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum albumin is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [22]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [22] - ITT Population
    No statistical analyses for this end point

    Secondary: Cholesterol at the indicated time points

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    End point title
    		 Cholesterol at the indicated time points
    End point description
    Clinical chemistry laboratory parameters included cholesterol which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for cholesterol is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), cholesterol is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [23]
    Units: millimoles per liter (mmol/L)
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [23] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in levels of cholesterol at the indicated time points

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    End point title
    		 Change from Baseline in levels of cholesterol at the indicated time points
    End point description
    Clinical chemistry laboratory parameters included cholesterol which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for cholesterol is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), cholesterol is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [24]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [24] - ITT Population
    No statistical analyses for this end point

    Secondary: Summary of incidence of oedema by severity

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    End point title
    		 Summary of incidence of oedema by severity
    End point description
    Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the oedema in participants. Investigators are physically reviewing participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. oedema extending beyond calf) during study. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Screening and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [25]
    Units: Participants
    Notes
    [25] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36 v2 Quality of Life (QoL) questionnaire score

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    End point title
    		 Change from Baseline in SF-36 v2 Quality of Life (QoL) questionnaire score
    End point description
    Health-related quality of life is being assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. The SF-36 v2 is referred to as a generic measure as it assesses health concepts that represent basic human values that are relevant to everyone’s functional status and wellbeing. SF-36 is being administered prior to any procedures at Screening, Day 0, and Weeks 12, 28, 52, 76 and 104/4 week post last dose. For participants on 12 weekly follow-up, assessment of SF-36 is being conducted at the closest visit to those in the treatment phase. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    From Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [26]
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    ±
    Notes
    [26] - ITT Population
    No statistical analyses for this end point

    Secondary: Summary of maximum observed serum concentration (Cmax) of belimumab at the indicated time points

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    End point title
    		 Summary of maximum observed serum concentration (Cmax) of belimumab at the indicated time points
    End point description
    The first occurrence of Cmax is being determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters are being calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [27]
    Units: nanograms per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [27] - PK Population: all par. in the ITT Population for whom a PK sample was obtained and analyzed.
    No statistical analyses for this end point

    Secondary: Summary of minimum observed concentration (Cmin) of belimumab at the indicated time points

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    End point title
    		 Summary of minimum observed concentration (Cmin) of belimumab at the indicated time points
    End point description
    Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment of steady state. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [28]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [28] - PK Population
    No statistical analyses for this end point

    Secondary: Summary of area under the serum concentration-time curve to the last quantifiable concentration (AUC[0-2])

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    End point title
    		 Summary of area under the serum concentration-time curve to the last quantifiable concentration (AUC[0-2])
    End point description
    The AUC(0-2) is being determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis are being collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [29]
    Units: hours times nanograms per milliliter
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [29] - PK Population
    No statistical analyses for this end point

    Secondary: Summary of total amount of urine excreted Ae(0-24)

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    End point title
    		 Summary of total amount of urine excreted Ae(0-24)
    End point description
    PK parameters from the urine concentration data: urine Ae(0-24) is being assessed. 24 h urine collections for PK analysis are being collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach will be undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis is being conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [30]
    Units: mg
        arithmetic mean (standard deviation)
    ±
    Notes
    [30] - PK Population
    No statistical analyses for this end point

    Secondary: Summary of clinical chemistry laboratory parameters assessed up to Week 116/16 week post last dose

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    End point title
    		 Summary of clinical chemistry laboratory parameters assessed up to Week 116/16 week post last dose
    End point description
    Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase, total protein, eGFR, cholesterol, inorganic phosphates, magnesium, immunoglobulin (Ig) G, IgA, IgM and lactate dehydrogenase assessed up to Week 128/6 month follow-up visit. IgG is being assessed at Screening, then each dosing visit up to Week 52 and Weeks 60, 68, 76, 84, 92, 100, Week 104/4 week post last dose and 16 week and 6 month follow-up visits. IgA and IgM is being assessed at Screening, and then at Week 0, 28 and at Week 104/4 week post last dose. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [31]
    Units: To be determined
        arithmetic mean (standard deviation)
    ±
    Notes
    [31] - ITT Population
    No statistical analyses for this end point

    Secondary: Summary of haematology laboratory parameters assessed up to Week 116/16 week post last dose

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    End point title
    		 Summary of haematology laboratory parameters assessed up to Week 116/16 week post last dose
    End point description
    Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, haemoglobin, haematocrit, neutrophils, lymphocytes, monocytes, eosinophils and basophils assessed up to Week 128/6 month follow-up visit. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [32]
    Units: To be determined
        arithmetic mean (standard deviation)
    ±
    Notes
    [32] - ITT Population
    No statistical analyses for this end point

    Secondary: Summary of urinalysis parameters assessed up to Week 116/16 week post last dose

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    End point title
    		 Summary of urinalysis parameters assessed up to Week 116/16 week post last dose
    End point description
    Urinalysis included pH, glucose, protein, blood and ketones by dipstick, microscopic examination and urine pregnancy assessed up to Week 128/6 month follow-up visit. Urinalysis is done pre-dose during dosing visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [33]
    Units: To be determined
        arithmetic mean (standard deviation)
    ±
    Notes
    [33] - ITT Population
    No statistical analyses for this end point

    Secondary: Vital signs measurements assessed up to 116/16 week follow-up visit

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    End point title
    		 Vital signs measurements assessed up to 116/16 week follow-up visit
    End point description
    Vital signs including systolic and diastolic blood pressure, pulse rate and temperature were measured throughout the 104-week treatment period and follow-up. Sitting blood pressure/heart rate and body temperature are being measured pre-dose on dosing days. Blood pressure is being measured on at least 2 clinic visits during the Screening phase or by a 24 h ambulatory blood pressure monitor. Additionally, weight is being measured at all dosing visits prior to dosing and at Week 104. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [34]
    Units: To be determined
        arithmetic mean (standard deviation)
    ±
    Notes
    [34] - ITT Population
    No statistical analyses for this end point

    Secondary: Immunogenicity during the 104-week treatment period and up to Week 116/16 week follow-up visit

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    End point title
    		 Immunogenicity during the 104-week treatment period and up to Week 116/16 week follow-up visit
    End point description
    Immunogenicity samples are being collected pre-dose on Weeks 0, 12, 28, 40, 52, 76 and 4 week post last dose and the 16 week post last dose visit for belimumab immunogenicity assay. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [35]
    Units: Participants
    Notes
    [35] - ITT Population
    No statistical analyses for this end point

    Secondary: Urine membrane attack complex (MAC)

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    End point title
    		 Urine membrane attack complex (MAC)
    End point description
    Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [36]
    Units: ug/umol
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [36] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in urine membrane attack complex (MAC)

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    End point title
    		 Change from Baseline in urine membrane attack complex (MAC)
    End point description
    Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [37]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [37] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in B Cell and T Cell subpopulations

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    End point title
    		 Change from Baseline in B Cell and T Cell subpopulations
    End point description
    Blood samples for flow cytometry quantification of peripheral lymphocyte (B cell and T cell) subpopulations and activation markers are being collected on Day 0 and at the Week 8, 16, 28, 4 week post last dose and 6 month post last dose visits. B cell Facs panels are being used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel are being used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 128/6 month post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [38]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [38] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in cytokines/chemokines

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    End point title
    		 Change from Baseline in cytokines/chemokines
    End point description
    Cytokine/chemokines associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification is being used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Cytokine/chemokine samples are being collected on Day 0 and Weeks 8, 16, 28, 52, 76, and 4 week post last dose. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 104/4 week post last dose
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [39]
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [39] - ITT Population
    No statistical analyses for this end point

    Secondary: Serum BLys levels

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    End point title
    		 Serum BLys levels
    End point description
    Free BLyS protein is being analyzed using an ELISA. Serum samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [40]
    Units: pg/mL
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [40] - ITT Population
    No statistical analyses for this end point

    Secondary: Urine BLys levels as a ratio to creatinine

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    End point title
    		 Urine BLys levels as a ratio to creatinine
    End point description
    B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS:creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 116/16 week follow-up visit
    End point values
    		 Belimumab 10 mg/kg IV
    Number of subjects analysed
    0 [41]
    Units: pg/mmol
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [41] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment up to Week 28, or 4 week post last dose End of Therapy visit for participants withdrawing from treatment earlier than Week 28.
    Adverse event reporting additional description
    On-therapy SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who received at least one dose of investigational drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Belimumab 10 mg/kg IV
    Reporting group description
    		 Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.

    Serious adverse events
    		 Belimumab 10 mg/kg IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Belimumab 10 mg/kg IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Investigations
    Eosinophil count increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    5
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Ascites
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Rash pruritic
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Swelling face
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Arthralgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Cellulitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 May 2012
    Clarification of stopping criteria; additional rationale for hypogammaglobulinaemia including stopping criteria and monitoring; removal of Disease-Related Events provision; clarification of SRT
    21 Dec 2012
    Addition of Benlysta programme generic suicidality monitoring text; extension of biopsy inclusion to 7 years (3 years non-active); extension of time before stopping study treatment when hypogammaglobulinaemia without improvement; removal of requirement for 6 month post dose immunogenicity; addition of aliskiren, ACTH to prohibited medications; minor clarifications and consistency corrections
    10 Jan 2014
    Addition of 6 month post treatment follow-up; PML text revision; alternative use of 24h protein excretion instead of uPCR in eligibility and for increased dosing frequency threshold; reduction in rituximab washout; removal NSAID prohibition; removal of change in urine belimumab endpoint; minor clarifications and consistency corrections
    06 Mar 2014
    Strengthening of discouragement against use of NSAIDs at MHRA request

    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.
    None reported
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