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NCT01029652 · OUTCOME

Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)

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.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Last post-baseline flare (during 24 weeks overall)

What was measured

Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).

Analysis population: The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.

Groups in this outcome

Canakinumab 150 mg

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.

Triamcinolone Acetonide 40 mg

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.

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 mg35
Triamcinolone Acetonide 40 mg43

Reported measurements

None
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg0.0Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg0.0Not reportedNot reportedNot reportedNot reported
Mild
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg0.0Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg2.3Not reportedNot reportedNot reportedNot reported
Moderate
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg14.3Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg16.3Not reportedNot reportedNot reportedNot reported
Severe
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg77.1Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg60.5Not reportedNot reportedNot reportedNot reported
Extreme
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg8.6Not reportedNot reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg20.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    title
    None
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        2.3
    title
    Mild
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14.3
      2. group Id
        OG001
        value
        16.3
    title
    Moderate
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        77.1
      2. group Id
        OG001
        value
        60.5
    title
    Severe
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8.6
      2. group Id
        OG001
        value
        20.9
    title
    Extreme
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).
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
    OG000
    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
    OG001
    title
    Triamcinolone Acetonide 40 mg
param Type
NUMBER
population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.
reporting Status
POSTED
time Frame
Last post-baseline flare (during 24 weeks overall)
title
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice