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NCT01080131 · OUTCOME

Mean Number of New Gout Flares Per Patient During 24 Weeks

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
new flares per patient
Interval / dispersion
Standard Deviation
Time frame
24 weeks

What was measured

Patients met definition of new flare if they had: * Flare in joint, not a previously affected joint(at baseline or during study) * Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.

Analysis population: Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of 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. 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

Source class 1
Values in new flares per patient · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Canakinumab 150 mg0.350.694Not reportedNot reportedNot reported
Triamcinolone Acetonide 40 mg0.801.115Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.694
        value
        0.35
      2. group Id
        OG001
        spread
        1.115
        value
        0.80
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Patients met definition of new flare if they had: * Flare in joint, not a previously affected joint(at baseline or during study) * Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
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
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
reporting Status
POSTED
time Frame
24 weeks
title
Mean Number of New Gout Flares Per Patient During 24 Weeks
type
SECONDARY
unit Of Measure
new flares per patient

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

Preserved source evidence · Not medical advice