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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate Efficacy and Safety of Treatment with CNTO 136 Administered Intravenously in Subjects with Active Lupus Nephritis

    Summary
    EudraCT number
    2010-020968-38
    Trial protocol
    BE   NL  
    Global end of trial date
    25 Sep 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO136LUN2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01273389
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Antwerpseweg 15-17, B-2340 Beerse, Belgium,
    Public contact
    Clinical Registry Group, Janssen Cilag International NV, +31 715242166, clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Cilag International NV, +31 715242166, clinicaltrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy and safety of CNTO 136 (sirukumab) administered intravenously (IV) in subjects with active, International Society of Nephrology (ISN)/Renal Pathology Society (RPS) Class III and IV lupus nephritis (LN).
    Protection of trial subjects
    A Data Review Committee (DRC) was established that was composed of Johnson & Johnson clinicians and statisticians who were independent of the study team. The DRC was available to assess unblinded safety data and to make recommendations regarding the study, if needed, upon study team recommendation. Safety was assessed by monitoring (adverse effects (AEs), (serious adverse effects (SAEs), chemistry and hematology laboratory tests, lipid tests, vital signs, general physical examination and skin evaluations, concomitant medication review, (electrocardiogram (ECG) testing (heart rate, PR interval, QRS interval, QT interval, and QTc using QTcB and QTcF correction methods), pregnancy testing, infusion reactions, and antibodies to CNTO 136, as well as clinical assessments of their lupus disease.
    Background therapy
    Subjects were required to receive stable immunosuppression with mycophenolate mofetil (MMF) 1 to 3 g/day (or equivalent dose of mycophenolic acid/ mycophenolate sodium [MPA]) with/without corticosteroids up to prednisone equivalent of 20 mg/day, or azathioprine 1 to 3 mg/kg/day with/without corticosteroids up to prednisone equivalent of 20 mg/day. They were also to be on a stable regimen of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blockers (ARBs), unless they were previously intolerant to or had contraindication to ACE inhibitors and ARBs.
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Jan 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Thailand: 6
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    Belgium: 3
    Worldwide total number of subjects
    25
    EEA total number of subjects
    5
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted from 28 January 2011 to 25 September 2013 in 18 centers.

    Pre-assignment
    Screening details
    An 8-week run-in period was used to establish the stability of baseline renal parameters prior to randomization and the first study agent administration. A total of 25 subjects were randomized and treated in the study: 21 subjects in the CNTO 136 group and 4 subjects in the placebo group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received comparable volume of placebo matching with CNTO 136 as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo (5% dextrose solution) matching with CNTO 136 as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24.

    Arm title
    CNTO 136
    Arm description
    Subjects received CNTO 136, 10 milligram per kilogram of body weight (mg/kg) as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO136
    Investigational medicinal product code
    Other name
    Sirukumab, fully human anti-IL-6 mAb
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received CNTO 136, 10 milligram per kilogram of body weight (mg/kg) as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24.

    Number of subjects in period 1
    Placebo CNTO 136
    Started
    4
    21
    Completed
    4
    15
    Not completed
    0
    6
         Consent withdrawn by subject
    -
    1
         Non Serious Adverse Event
    -
    3
         Serious Adverse Events
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received comparable volume of placebo matching with CNTO 136 as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24

    Reporting group title
    CNTO 136
    Reporting group description
    Subjects received CNTO 136, 10 milligram per kilogram of body weight (mg/kg) as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24.

    Reporting group values
    Placebo CNTO 136 Total
    Number of subjects
    4 21 25
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    4 21 25
        From 65 to 84 years
    0 0 0
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: Years
        arithmetic mean (standard deviation)
    37.8 ± 11.44 30.6 ± 7.72 -
    Title for Gender
    Units: subjects
        Female
    4 17 21
        Male
    0 4 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received comparable volume of placebo matching with CNTO 136 as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24

    Reporting group title
    CNTO 136
    Reporting group description
    Subjects received CNTO 136, 10 milligram per kilogram of body weight (mg/kg) as intravenous infusion on Week 0, 4, 8, 12, 16, 20, and 24.

    Subject analysis set title
    Modified Intent-to-Treat (m-ITT) Population
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    m-ITT population included all subjects who received at least 1 (partial or complete) dose of study agent and had baseline and at least 1 evaluable post baseline efficacy outcome measurement.

    Subject analysis set title
    Safety population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis population included all subjects who were randomized and received at least 1 dose of study agent.

    Primary: Percent Reduction From Baseline in Proteinuria at Week 24

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    End point title
    Percent Reduction From Baseline in Proteinuria at Week 24 [1]
    End point description
    Percent reduction from baseline in proteinuria measured by protein/creatinine (P/C) ratio in a 12 hour urine collection obtained at Week 24. A last observation carried forward (LOCF) procedure was used to impute missing values if a subject had data for at least one post baseline evaluation. A negative percentage reduction indicates an increase (worsening) in urine proteinuria.
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    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: No statistical analysis were performed for this endpoint
    End point values
    Placebo CNTO 136
    Number of subjects analysed
    4 [2]
    20 [3]
    Units: Percentage of subjects
        median (full range (min-max))
    -43.26 (-257.5 to 49.8)
    0 (-490.5 to 90.9)
    Notes
    [2] - Modified Intent-to-Treat Analysis population
    [3] - Modified Intent-to-Treat Analysis population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Reduction in Proteinuria by at least 50% From Baseline up to Week 24

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    End point title
    Percentage of Subjects with Reduction in Proteinuria by at least 50% From Baseline up to Week 24
    End point description
    The percentage of subjects with a reduction in in proteinuria by at least 50% from baseline at any time through Week 24 is reported.
    End point type
    Secondary
    End point timeframe
    Baseline Up to Week 24
    End point values
    Placebo CNTO 136
    Number of subjects analysed
    4 [4]
    20 [5]
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0 to 0)
    20 (5.7 to 43.7)
    Notes
    [4] - Modified Intent-to-treat Analysis Population
    [5] - Modified Intent-to-treat Analysis Population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with a Meaningful Reduction in Proteinuria

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    End point title
    Percentage of Subjects with a Meaningful Reduction in Proteinuria
    End point description
    Percentage of Subjects with meaningful reduction of proteinuria at any time through Week 24 was recorded. Meaningful reduction in proteinuria was defined as P/C (protein/creatinine) ratio to ≤ 0.5 for nonnephrotic subjects (defined as subjects with P/C ratio ≤ 3.0 at baseline); or at least 50% reduction in P/C ratio and P/C ratio ≤ 3.0 for nephrotic subjects.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    Placebo CNTO 136
    Number of subjects analysed
    4 [6]
    20 [7]
    Units: Percentage of Subjects
        number (confidence interval 95%)
    0 (0 to 0)
    15 (3.2 to 37.9)
    Notes
    [6] - Modified Intent-to-treat Analysis population
    [7] - Modified Intent-to-treat Analysis population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with no Worsening in Glomerular Filtration Rate (GFR)

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    End point title
    Percentage of Subjects with no Worsening in Glomerular Filtration Rate (GFR)
    End point description
    It was measured as the Percentage of subjects with no worsening in GFR at any time through Week 24. No worsening in GFR was defined as ≤ 15% decrease from baseline GFR.
    End point type
    Secondary
    End point timeframe
    Baseline up to week 24
    End point values
    Placebo CNTO 136
    Number of subjects analysed
    4 [8]
    20 [9]
    Units: Percentage of subjects
        number (not applicable)
    75
    45
    Notes
    [8] - Modified Intent-to-treat Analysis population
    [9] - Modified Intent-to-treat Analysis Population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Subject’s Global Assessment of Disease Activity

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    End point title
    Mean Change From Baseline in Subject’s Global Assessment of Disease Activity
    End point description
    The Subject's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm). Where, 0 cm=no disease activity and 10 cm=worst possible disease activity. Here, “n” is the number of subjects analysed for this outcome measure at specific time point
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    Placebo CNTO 136
    Number of subjects analysed
    4 [10]
    20 [11]
    Units: Percent Change
    arithmetic mean (standard deviation)
        Baseline (n=4, 20)
    3.5 ± 1.19
    4.1 ± 2.46
        Mean Change at Week 24 (n=4, 20)
    -0.55 ± 1.928
    -0.79 ± 2.662
    Notes
    [10] - m-ITT population
    [11] - m-ITT population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Physician's Global Assessment of Disease Activity

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    End point title
    Mean Change From Baseline in Physician's Global Assessment of Disease Activity
    End point description
    The Subject's Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS) (0 to 10 cm) where, 0 cm=no disease activity and 10 cm=worst possible disease activity. Here, “n” is the number of subjects analysed for this outcome measure at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    End point values
    Placebo CNTO 136
    Number of subjects analysed
    4 [12]
    20 [13]
    Units: Percent Change
    arithmetic mean (standard deviation)
        Baseline (n=4, 20)
    4.5 ± 2.25
    4.2 ± 2.59
         Mean Change at Week 24 (n=4, 20)
    -0.85 ± 0.995
    -1.12 ± 2.073
    Notes
    [12] - m-ITT Population
    [13] - m-ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Initiation study up to 16 weeks after the final administration of drug
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    CNTO 136 10 mg/kg
    Reporting group description
    CNTO 136 10 mg/kg administered intravenously

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Serious adverse events
    CNTO 136 10 mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 21 (47.62%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Lymphadenitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic Thrombocytopenic Purpura
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Lupus Nephritis
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster Disseminated
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Haemophilus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubo-Ovarian Abscess
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    CNTO 136 10 mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 21 (95.24%)
    4 / 4 (100.00%)
    Vascular disorders
    Diastolic Hypertension
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    5
    0
    Hypotension
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Generalised Oedema
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Oedema Peripheral
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Rhinitis Allergic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Respiratory Tract Congestion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Muscle Strain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Pericardial Disease
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 21 (19.05%)
    0 / 4 (0.00%)
         occurrences all number
    6
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Ear Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Haematotympanum
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eczema Eyelids
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Ascites
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Abdominal Wall Haematoma
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Enteritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Tongue Ulceration
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Cutaneous Lupus Erythematosus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Dermatitis Allergic
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Butterfly Rash
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Photosensitivity Reaction
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Solar Dermatitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Telangiectasia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Lupus Nephritis
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    Haematuria
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Chondritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Escherichia Bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Anal Abscess
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Herpes Zoster
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Oral Candidiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Otitis Media
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    Pharyngitis
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    7 / 21 (33.33%)
    1 / 4 (25.00%)
         occurrences all number
    8
    1
    Urinary Tract Infection
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Oct 2011
    It involved extension in time frame from 3 months to approximately 6 months prior to screening for having a renal biopsy showing active nephritis as one of the possible criteria to characterize subjects as having persistently active LN (lupus nephritis); clarification to the SLEDAI-2K (systemic lupus erythematosus disease activity index 2000) and the SRI-50 (systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) responder index-50) assessments; clarifications to the urine sample collection and analysis process; clarification to the proteinuria requirement criteria; clarification to the footnotes for the antibodies to CNTO 136 and CNTO 136 concentration samples; clarification to include an option for subjects to receive the equivalent immunosuppressant therapy mycophenolic acid/ mycophenolate sodium (MPA) instead of MMF; clarification to the timing with assessments and dosage administration.

    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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