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NCT01029652 · OUTCOME

Time to First Intake of Rescue Medication After the Last Post Baseline Flare.

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
MEDIAN
Unit
Hours
Interval / dispersion
95% Confidence Interval
Time frame
72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

What was measured

The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.

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. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in 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

Source class 1
Values in Hours · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mgNANot reported12NAThe data were not estimable as \<50% patients took rescue medication.
Triamcinolone Acetonide 40 mgNANot reported11NAThe data were not estimable as \<50% patients took rescue medication.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The data were not estimable as \<50% patients took rescue medication.
        group Id
        OG000
        lower Limit
        12
        upper Limit
        NA
        value
        NA
      2. comment
        The data were not estimable as \<50% patients took rescue medication.
        group Id
        OG001
        lower Limit
        11
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      43
    units
    Participants
description
The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.
dispersion Type
95% Confidence Interval
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
MEDIAN
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. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in analysis.
reporting Status
POSTED
time Frame
72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
title
Time to First Intake of Rescue Medication After the Last Post Baseline Flare.
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice