Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01029652 · FLOW

Participant flow

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.

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. After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study
    id
    FG000
    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. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study .
    id
    FG001
    title
    Triamcinolone Acetonide 40 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Patient Withdrew Consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative problems
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        115
      2. group Id
        FG001
        num Subjects
        115
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        115
      type
      Full Analysis Set (FAS), Safety Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        105
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Core Study (0-12 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Deviation
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        90
      2. group Id
        FG001
        num Subjects
        85
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        80
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Extension Study 1 (12-24 Weeks)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Unsatisfactory therapeutic effect
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        66
      type
      STARTED
    2. achievements
      1. comment
        Includes patients re-treated with canakinumab over 72 weeks study duration overall
        group Id
        FG000
        num Subjects
        69
      2. comment
        Includes patients switched to canakinumab from Week 25 - Week 72
        group Id
        FG001
        num Subjects
        39
      type
      Re-treated With or Switch to Canakinumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        63
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Extension Study 2 (25-72 Weeks)
pre Assignment Details
Two patients randomized to canakinumab did not receive any study medication and were discontinued from the core study on the day of randomization, with the reason for discontinuation listed as Administrative Problems.
Complete source fields
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. After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study
    id
    FG000
    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. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study .
    id
    FG001
    title
    Triamcinolone Acetonide 40 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Patient Withdrew Consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative problems
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        115
      2. group Id
        FG001
        num Subjects
        115
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        115
      type
      Full Analysis Set (FAS), Safety Set
    3. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        105
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Core Study (0-12 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Unsatisfactory therapeutic effect
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Deviation
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        90
      2. group Id
        FG001
        num Subjects
        85
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        87
      2. group Id
        FG001
        num Subjects
        80
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Extension Study 1 (12-24 Weeks)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Unsatisfactory therapeutic effect
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        66
      type
      STARTED
    2. achievements
      1. comment
        Includes patients re-treated with canakinumab over 72 weeks study duration overall
        group Id
        FG000
        num Subjects
        69
      2. comment
        Includes patients switched to canakinumab from Week 25 - Week 72
        group Id
        FG001
        num Subjects
        39
      type
      Re-treated With or Switch to Canakinumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        63
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Extension Study 2 (25-72 Weeks)
pre Assignment Details
Two patients randomized to canakinumab did not receive any study medication and were discontinued from the core study on the day of randomization, with the reason for discontinuation listed as Administrative Problems.

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

Preserved source evidence · Not medical advice