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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

    Summary
    EudraCT number
    2008-007762-39
    Trial protocol
    DE  
    Global end of trial date
    17 Dec 2010

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Dec 2019
    First version publication date
    31 Mar 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Minor corrections

    Trial information

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    Trial identification
    Sponsor protocol code
    IL1T-GA-0816
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00958438
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Study Name: PRE-SURGE 2
    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
    17 Dec 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of 160 mg and 80 mg of weekly subcutaneous (SC) Rilonacept therapy compared to placebo in the prophylaxis of flares in subjects with intercritical gout initiating therapy with allopurinol.
    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
    Subjects received a daily dose of allopurinol 300 mg from Day 1 to the end of the follow-up period. Dose was increased, if needed, every 2 weeks in 100 mg increments to a maximum dose of 800 mg per day until the target serum uric acid level (<6.0 mg/dL) was achieved.
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Mar 2009
    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
    South Africa: 186
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    India: 13
    Country: Number of subjects enrolled
    Indonesia: 12
    Worldwide total number of subjects
    248
    EEA total number of subjects
    25
    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)
    213
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 57 study sites in European Union (EU) and rest of the world between 7 March 2009 and 17 December 2010. A total of 471 subjects were screened in the study.

    Pre-assignment
    Screening details
    Out of 471 subjects, 248 were randomized and treated in the study. Subjects were randomized in 1:1:1 ratio to receive Placebo or Rilonacept 80 mg or Rilonacept 160 mg.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    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 80 mg
    Arm description
    Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 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.

    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 80 mg Rilonacept 160 mg
    Started
    82
    82
    84
    Completed
    72
    72
    78
    Not completed
    10
    10
    6
         Protocol deviation
    3
    2
    2
         Other than specified
    2
    3
    2
         Physician decision
    1
    -
    1
         Consent withdrawn by subject
    4
    2
    1
         Adverse Event
    -
    3
    -

    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 80 mg
    Reporting group description
    Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept 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 80 mg Rilonacept 160 mg Total
    Number of subjects
    82 82 84 248
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.7 ± 12.87 52.6 ± 11.47 49 ± 11.77 -
    Gender categorical
    Units: Subjects
        Female
    5 5 7 17
        Male
    77 77 77 231
    Race
    Units: Subjects
        Asian
    29 23 30 82
        Black or African American
    10 14 10 34
        White
    43 45 44 132
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    82 82 84 248
        Hispanic or Latino
    0 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 80 mg
    Reporting group description
    Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept 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: Number of Gout Flares Per Subject Assessed From Day 1 to Day 113 (Week 16)

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    End point title
    Number of Gout Flares Per Subject Assessed From Day 1 to Day 113 (Week 16) [1]
    End point description
    Gout flare was defined as 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 participant was reported for this endpoint. 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
    Primary
    End point timeframe
    Day 1 to Day 133 (Week 16)
    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 80 mg Rilonacept 160 mg
    Number of subjects analysed
    82
    82
    83
    Units: Gout flares
        arithmetic mean (standard deviation)
    1.23 ± 1.57
    0.35 ± 0.67
    0.34 ± 0.86
    No statistical analyses for this end point

    Secondary: Number of Modified Gout Flares per Subject From Day 1 to Day 113 (Week 16)

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    End point title
    Number of Modified Gout Flares per Subject From Day 1 to Day 113 (Week 16)
    End point description
    Modified Gout Flare was defined using modified definition of a gout flare as subject-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per subject were reported for this endpoint. Analysis was performed on FAS population. Here, number of subjects analyzed= subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 113 (Week 16)
    End point values
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Number of subjects analysed
    82
    82
    83
    Units: modified gout flares
        arithmetic mean (standard deviation)
    1.51 ± 1.87
    0.62 ± 1.32
    0.48 ± 0.99
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with at Least one Flare From Day 1 to Day 113 (Week 16)

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    End point title
    Percentage of Subjects with at Least one Flare From Day 1 to Day 113 (Week 16)
    End point description
    Gout flare was defined as 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 in this endpoint. Analysis was performed on FAS population.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 113 (Week 16)
    End point values
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Number of subjects analysed
    82
    82
    84
    Units: Percentage of Participants
        number (not applicable)
    56.1
    25.6
    20.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least two Flares From Day 1 to Day 113 (Week 16)

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    End point title
    Percentage of Subjects With at Least two Flares From Day 1 to Day 113 (Week 16)
    End point description
    Gout flare was defined as 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 flares was reported in this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 113 (Week 16)
    End point values
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Number of subjects analysed
    82
    82
    84
    Units: Percentage of Subjects
        number (not applicable)
    32.9
    8.5
    6
    No statistical analyses for this end point

    Secondary: Number of Gout Flare Days per Subject From Day 1 to Day 113 (Week 16)

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    End point title
    Number of Gout Flare Days per Subject From Day 1 to Day 113 (Week 16)
    End point description
    Gout flare was defined as 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 flare days per subject was reported for this endpoint. Analysis was performed on FAS population. Here, number of subjects analyzed= subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 113 (Week 16)
    End point values
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Number of subjects analysed
    82
    82
    83
    Units: gout flare days
        arithmetic mean (standard deviation)
    11.7 ± 21
    4.3 ± 17.13
    1.86 ± 5.8
    No statistical analyses for this end point

    Secondary: Number of Gout Flare Days with the Subject's Pain Score of 5 or More (From Daily Diary) per Subject From Day 1 to Day 113 (Week 16)

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    End point title
    Number of Gout Flare Days with the Subject's Pain Score of 5 or More (From Daily Diary) per Subject From Day 1 to Day 113 (Week 16)
    End point description
    Subjects were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, subjects were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), subjects were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours. Analysis was performed on FAS population. Here, number of subjects analyzed= subjects with available data for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 113 (Week 16)
    End point values
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Number of subjects analysed
    82
    82
    83
    Units: gout flare days
        arithmetic mean (standard deviation)
    4.28 ± 7.67
    1.67 ± 8.43
    0.88 ± 2.66
    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
    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.

    Reporting group title
    Rilonacept 80 mg
    Reporting group description
    Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept 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.

    Serious adverse events
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 82 (4.88%)
    5 / 82 (6.10%)
    3 / 84 (3.57%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 82 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 82 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Umbilical hernia, obstructive
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 82 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 82 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 82 (1.22%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Rilonacept 80 mg Rilonacept 160 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 82 (14.63%)
    20 / 82 (24.39%)
    20 / 84 (23.81%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    2 / 82 (2.44%)
    6 / 82 (7.32%)
    4 / 84 (4.76%)
         occurrences all number
    3
    6
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 82 (2.44%)
    5 / 82 (6.10%)
    1 / 84 (1.19%)
         occurrences all number
    2
    6
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 82 (0.00%)
    6 / 82 (7.32%)
    7 / 84 (8.33%)
         occurrences all number
    0
    21
    20
    Infections and infestations
    Influenza
         subjects affected / exposed
    6 / 82 (7.32%)
    5 / 82 (6.10%)
    5 / 84 (5.95%)
         occurrences all number
    6
    5
    5
    Nasopharyngitis
         subjects affected / exposed
    2 / 82 (2.44%)
    3 / 82 (3.66%)
    6 / 84 (7.14%)
         occurrences all number
    2
    6
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jan 2009
    - Removed the collection of blood samples for proteomics and RNA and information regarding analyses of such samples; - Clarified requirement for collection of study drug injection volume by the subject; - Indicated that this was a phase 3 trial; - Made administrative clarifications and updates to the protocol.
    14 Oct 2009
    - Specified that subjects with a purified protein derivative (PPD) tuberculin skin test of ≥10 mm in-duration were ineligible for the study; - Specified that human immuno-deficiency virus (HIV) testing was required for sites in South Africa. - Made miscellaneous administrative clarifications and updates to the protocol.
    30 Nov 2009
    - Specified that subjects with a history of inadequate urate-lowering response to allopurinol, history of allergic reaction, contraindication,or intolerance to allopurinol, were ineligible for the study; - Specified that subjects who had an absolute or relative contraindication to both naproxen and oral glucocorticoids (e.g., prednisolone, prednisone) were ineligible for the study; - 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; - Made administrative corrections to the protocol.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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