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NCT01080131 · OUTCOME

Amount of Rescue Medication Taken

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 Colchicines Including a 12 Week Extension and a 1 Year Open-label 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.

Measure
MEAN
Unit
mg
Interval / dispersion
Standard Deviation
Time frame
For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

What was measured

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: * Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. * If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

Analysis population: For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.

Groups in this outcome

Canakinumab 150 mg

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Triamcinolone Acetonide 40 mg

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Canakinumab 150 mg112
Triamcinolone Acetonide 40 mg114

Reported measurements

Baseline flare: Acetaminophen [N=112, 114]
Values in mg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg1375.02726.63Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg2526.53925.13Not reportedNot reportedNot reported
Baseline flare: Codeine [N=112, 114]
Values in mg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg27.2100.40Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg60.6144.38Not reportedNot reportedNot reported
Baseline flare: Prednisone/Predinisone [N=112,114]
Values in mg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg9.235.32Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg19.344.88Not reportedNot reportedNot reported
Last flare: Acetaminophen [N=25, 46]
Values in mg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg2292.03462.65Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg1541.33771.33Not reportedNot reportedNot reported
Last flare: Codeine [N= 25, 46]
Values in mg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg64.8224.11Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg65.2178.70Not reportedNot reportedNot reported
Last flare: Prednisolone/Predinisone [N= 25, 46]
Values in mg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg5.614.46Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg18.348.00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2726.63
        value
        1375.0
      2. group Id
        OG001
        spread
        3925.13
        value
        2526.5
    title
    Baseline flare: Acetaminophen [N=112, 114]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        100.40
        value
        27.2
      2. group Id
        OG001
        spread
        144.38
        value
        60.6
    title
    Baseline flare: Codeine [N=112, 114]
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.32
        value
        9.2
      2. group Id
        OG001
        spread
        44.88
        value
        19.3
    title
    Baseline flare: Prednisone/Predinisone [N=112,114]
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3462.65
        value
        2292.0
      2. group Id
        OG001
        spread
        3771.33
        value
        1541.3
    title
    Last flare: Acetaminophen [N=25, 46]
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        224.11
        value
        64.8
      2. group Id
        OG001
        spread
        178.70
        value
        65.2
    title
    Last flare: Codeine [N= 25, 46]
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.46
        value
        5.6
      2. group Id
        OG001
        spread
        48.00
        value
        18.3
    title
    Last flare: Prednisolone/Predinisone [N= 25, 46]
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: * Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. * If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
    id
    OG000
    title
    Canakinumab 150 mg
  2. description
    Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
    id
    OG001
    title
    Triamcinolone Acetonide 40 mg
param Type
MEAN
population Description
For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.
reporting Status
POSTED
time Frame
For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
title
Amount of Rescue Medication Taken
type
SECONDARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice