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NCT01080131 · OUTCOME

Time to Complete Resolution of Pain; Survival Analysis

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
NUMBER
Unit
hours
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to 7 days post-dose (randomization)

What was measured

Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.

Analysis population: Full Analysis Set (FAS): All patients that received study drug.

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.

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.

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

Source class 1
Values in hours · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg144.0Not reported120NAThe upper limit was not estimable in the study as it is longer than duration of study.
Triamcinolone Acetonide 40 mgNANot reported168NAThe median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit was not estimable in the study as it is longer than duration of study.
        group Id
        OG000
        lower Limit
        120
        upper Limit
        NA
        value
        144.0
      2. comment
        The median time to complete resolution could not be estimated because \<50% of patients had a complete resolution during the time period.
        group Id
        OG001
        lower Limit
        168
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.
dispersion Type
95% Confidence Interval
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.
    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.
    id
    OG001
    title
    Triamcinolone Acetonide 40 mg
param Type
NUMBER
population Description
Full Analysis Set (FAS): All patients that received study drug.
reporting Status
POSTED
time Frame
Baseline to 7 days post-dose (randomization)
title
Time to Complete Resolution of Pain; Survival Analysis
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice