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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate-Lowering Therapy.

    Summary
    EudraCT number
    2008-007784-16
    Trial protocol
    DE  
    Global end of trial date
    13 Jan 2011

    Results information
    Results version number
    v2(current)
    This version publication date
    27 Feb 2020
    First version publication date
    31 Mar 2017
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    IL1T-GA-0815
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00856206
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Study Name: RE-SURGE
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc.
    Sponsor organisation address
    777 Old Saw Mill River Rd., Tarrytown, United States,  10591
    Public contact
    Clinical Trials information, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trials information, Regeneron Pharmaceuticals, Inc., clinicaltrials@regeneron.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
    15 Feb 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the safety and tolerability of 160 mg of subcutaneous (SC) therapy with Rilonacept in the prophylaxis of gout flares in subjects on uric acid-lowering therapy.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Mar 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 570
    Country: Number of subjects enrolled
    Taiwan: 11
    Country: Number of subjects enrolled
    United States: 684
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    India: 22
    Country: Number of subjects enrolled
    Indonesia: 14
    Worldwide total number of subjects
    1315
    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)
    1110
    From 65 to 84 years
    205
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 71 study sites in United States and rest of world (ROW) between 23 March 2009 to 14 January 2011. A total of 2311 subjects were screened in the study.

    Pre-assignment
    Screening details
    Out of 2311 subjects, 1315 were randomized and treated in the study. Subjects were randomized in 3:1 ratio to receive Rilonacept 160 mg or placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in left and right upper arm, the left and right abdomen, and the left and right thigh.

    Arm title
    Rilonacept 160 mg
    Arm description
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
    Arm type
    Experimental

    Investigational medicinal product name
    Rilonacept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection in left and right upper arm, the left and right abdomen, and the left and right thigh.

    Number of subjects in period 1
    Placebo Rilonacept 160 mg
    Started
    330
    985
    Completed
    276
    824
    Not completed
    54
    161
         Death
    2
    2
         Protocol deviation
    6
    18
         Adverse event
    10
    46
         Lack of efficacy
    1
    2
         Other than specified above
    3
    10
         Consent withdrawn by subject
    15
    36
         Decision by the Sponsor
    4
    8
         Lost to follow-up
    13
    39

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.

    Reporting group title
    Rilonacept 160 mg
    Reporting group description
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.

    Reporting group values
    Placebo Rilonacept 160 mg Total
    Number of subjects
    330 985 1315
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.4 ± 10.55 52.8 ± 11.48 -
    Gender categorical
    Units: Subjects
        Female
    33 128 161
        Male
    297 857 1154
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    11 38 49
        Not Hispanic or Latino
    319 947 1266
        Unknown or Not Reported
    0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    2 7 9
        Asian
    47 115 162
        Native Hawaiian or Other Pacific Islander
    1 3 4
        Black or African American
    70 202 272
        White
    210 658 868
        More than one race
    0 0 0
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.

    Reporting group title
    Rilonacept 160 mg
    Reporting group description
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.

    Primary: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included subjects with both serious and non-serious AEs. Safety analysis set that included all subjects who received any study drug and safety analyses were based on the treatment received.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 20
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    Placebo Rilonacept 160 mg
    Number of subjects analysed
    330
    935
    Units: percentage of participants
    number (not applicable)
        With at least 1 TEAE
    59.1
    66.6
        With TEAEs related to study drug
    13
    27.5
        With serious TEAEs
    3.9
    3.1
        With TEAEs resulting in drug Withdrwal
    3.3
    5
        With serious TEAEs resulting in drug withdrawal
    1.8
    1.1
        With TEAEs leading to study discontinuation
    3
    4.7
        With serious TEAE leading to study discontinuation
    1.5
    1
        Treatment emergent deaths
    0.3
    0.2
    No statistical analyses for this end point

    Secondary: Number of Gout Flares Per Subject Assessed From Day 1 to Day 112 (Week 16)

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    End point title
    Number of Gout Flares Per Subject Assessed From Day 1 to Day 112 (Week 16)
    End point description
    A gout flare was defined as subject reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per subject was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not. Full analysis set (FAS) that included all randomized subjects who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 112 (Week 16)
    End point values
    Placebo Rilonacept 160 mg
    Number of subjects analysed
    323
    952
    Units: Gout flares
        arithmetic mean (standard deviation)
    1.73 ± 2.69
    0.51 ± 1.17
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least One Flare From Day 1 to Day 112 (Week 16)

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    End point title
    Percentage of Subjects With at Least One Flare From Day 1 to Day 112 (Week 16)
    End point description
    A gout flare was defined as subject reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of subjects with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not. FAS that included all randomized subjects who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 112 (Week 16)
    End point values
    Placebo Rilonacept 160 mg
    Number of subjects analysed
    330
    985
    Units: percentage of subjects
        number (not applicable)
    51.1
    25.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least Two Flares From Day 1 to Day 112 (Week 16)

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    End point title
    Percentage of Subjects With at Least Two Flares From Day 1 to Day 112 (Week 16)
    End point description
    A gout flare was defined as subject reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of subjects with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted regardless whether the flares occurred during the treatment period or not. FAS that included all randomized subjects who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 112 (Week 16)
    End point values
    Placebo Rilonacept 160 mg
    Number of subjects analysed
    330
    985
    Units: percentage of subjects
        number (not applicable)
    34.7
    11.7
    No statistical analyses for this end point

    Secondary: Number of Gout Flare Days Per Subject From Day 1 to Day 112 (Week 16)

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    End point title
    Number of Gout Flare Days Per Subject From Day 1 to Day 112 (Week 16)
    End point description
    A gout flare was defined as subjects reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per subject was reported for this outcome measure. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period. FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of subjects analyzed=subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 112 (Week 16)
    End point values
    Placebo Rilonacept 160 mg
    Number of subjects analysed
    323
    952
    Units: Gout flare Days
        arithmetic mean (standard deviation)
    7.66 ± 11.79
    2.66 ± 7.69
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Rilonacept 160 mg
    Reporting group description
    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.

    Reporting group title
    Placebo
    Reporting group description
    Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.

    Serious adverse events
    Rilonacept 160 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 985 (3.15%)
    13 / 330 (3.94%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding varicose vein
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 985 (0.10%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer stage unspecified
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 985 (0.20%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    0 / 985 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 985 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pyrexia
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 985 (0.10%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 985 (0.10%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 985 (0.20%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 985 (0.20%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 985 (0.20%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 985 (0.20%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 985 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 985 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (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
    Renal impairment
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 985 (0.10%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty tophus
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 985 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 985 (0.20%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 985 (0.10%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (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 / 985 (0.10%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 985 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 985 (0.10%)
    0 / 330 (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: 5%
    Non-serious adverse events
    Rilonacept 160 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    266 / 985 (27.01%)
    74 / 330 (22.42%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    54 / 985 (5.48%)
    20 / 330 (6.06%)
         occurrences all number
    61
    21
    Nervous system disorders
    Headache
         subjects affected / exposed
    90 / 985 (9.14%)
    26 / 330 (7.88%)
         occurrences all number
    169
    45
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    61 / 985 (6.19%)
    1 / 330 (0.30%)
         occurrences all number
    195
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    65 / 985 (6.60%)
    20 / 330 (6.06%)
         occurrences all number
    85
    41
    Pain in extremity
         subjects affected / exposed
    52 / 985 (5.28%)
    15 / 330 (4.55%)
         occurrences all number
    74
    21

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Nov 2009
    It included the following changes: -Specified that subjects with a history of inadequate urate-lowering response to allopurinol, or a history of allergic reaction, contraindication, or intolerance to allopurinol, were ineligible for the study (for those subjects treated with allopurinol); -Specified that who had an absolute or relative contraindication to naproxen, oral glucocorticoids (e.g, prednisolone, prednisone), and colchicine were ineligible for the study; and also specified stopping rules for discontinuation of study drug; -Clarified that mandatory immediate termination from the study was required if a subject becomes pregnant during the study.

    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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