NCT01080131 · OUTCOME

Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study

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: Baseline to Week 12

What was measured

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.

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.

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

Group	Source count
Canakinumab 150 mg	112
Triamcinolone Acetonide 40 mg	114

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Canakinumab 150 mg	13.4	Not reported	Not reported	Not reported	Not reported
Triamcinolone Acetonide 40 mg	36.8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
13.4
group Id
OG001
value
36.8

denoms

counts
group Id
OG000
value
112
group Id
OG001
value
114
units
Participants

description

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.

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.
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.
id
OG001
title
Triamcinolone Acetonide 40 mg

param Type

NUMBER

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

Baseline to Week 12

title

Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice