NCT01080131 · OUTCOME

Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme

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: Percentage of participants
Interval / dispersion: Not reported
Time frame: From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

What was measured

For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.

Analysis population: The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.

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

Group	Source count
Canakinumab 150 mg	25
Triamcinolone Acetonide 40 mg	46

Reported measurements

First post-baseline flare [N= 12, 37]

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab 150 mg	66.7	Not reported	Not reported	Not reported	Not reported
Triamcinolone Acetonide 40 mg	78.4	Not reported	Not reported	Not reported	Not reported

Last post-baseline flare [N= 25, 46]

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab 150 mg	64.0	Not reported	Not reported	Not reported	Not reported
Triamcinolone Acetonide 40 mg	78.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
66.7
group Id
OG001
value
78.4
title
First post-baseline flare [N= 12, 37]
categories
measurements
group Id
OG000
value
64.0
group Id
OG001
value
78.3
title
Last post-baseline flare [N= 25, 46]

denoms

counts
group Id
OG000
value
25
group Id
OG001
value
46
units
Participants

description

groups

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
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

NUMBER

population Description

The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.

reporting Status

POSTED

time Frame

From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).

title

Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice