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NCT01029652 · BASELINE

Baseline characteristics

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study · Source last updated 2014-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      113
    2. group Id
      BG001
      value
      115
    3. group Id
      BG002
      value
      228
    units
    Participants
groups
  1. description
    Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
    id
    BG000
    title
    Canakinumab 150 mg
  2. description
    Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
    id
    BG001
    title
    Triamcinolone Acetonide 40 mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.18
          value
          54
        2. group Id
          BG001
          spread
          10.71
          value
          54.6
        3. group Id
          BG002
          spread
          10.93
          value
          54.3
    description
    Two patients randomized to canakinumab were not included in the data set (safety set) used to calculate demographic data as they did not receive any study medication and were discontinued from the study on the day of randomization.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          184
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          37
      title
      ≥ 65 - 74 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
      title
      ≥ 75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          209
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      113
    2. group Id
      BG001
      value
      115
    3. group Id
      BG002
      value
      228
    units
    Participants
groups
  1. description
    Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
    id
    BG000
    title
    Canakinumab 150 mg
  2. description
    Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
    id
    BG001
    title
    Triamcinolone Acetonide 40 mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.18
          value
          54
        2. group Id
          BG001
          spread
          10.71
          value
          54.6
        3. group Id
          BG002
          spread
          10.93
          value
          54.3
    description
    Two patients randomized to canakinumab were not included in the data set (safety set) used to calculate demographic data as they did not receive any study medication and were discontinued from the study on the day of randomization.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          184
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          37
      title
      ≥ 65 - 74 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
      title
      ≥ 75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          209
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice