NCT01029652 · OUTCOME

Amount of Rescue Medication Taken

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: MEAN
Unit: mg
Interval / dispersion: Standard Deviation
Time frame: 7 days last post-baseline flare (during 24 weeks)

What was measured

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: * Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. * If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

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 at 7 days last post-baseline flare were included in this 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

Group	Source count
Canakinumab 150 mg	35
Triamcinolone Acetonide 40 mg	43

Reported measurements

Acetaminophen

Values in mg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Canakinumab 150 mg	1931.4	3266.12	Not reported	Not reported	Not reported
Triamcinolone Acetonide 40 mg	2058.1	3331.33	Not reported	Not reported	Not reported

Codeine

Values in mg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Canakinumab 150 mg	7.7	25.56	Not reported	Not reported	Not reported
Triamcinolone Acetonide 40 mg	46.0	118.26	Not reported	Not reported	Not reported

Prednisolone/Prednisone

Values in mg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Canakinumab 150 mg	4.1	17.34	Not reported	Not reported	Not reported
Triamcinolone Acetonide 40 mg	21.6	47.42	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
3266.12
value
1931.4
group Id
OG001
spread
3331.33
value
2058.1
title
Acetaminophen
categories
measurements
group Id
OG000
spread
25.56
value
7.7
group Id
OG001
spread
118.26
value
46.0
title
Codeine
categories
measurements
group Id
OG000
spread
17.34
value
4.1
group Id
OG001
spread
47.42
value
21.6
title
Prednisolone/Prednisone

denoms

counts
group Id
OG000
value
35
group Id
OG001
value
43
units
Participants

description

dispersion Type

Standard Deviation

groups

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
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

MEAN

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 at 7 days last post-baseline flare were included in this analysis.

reporting Status

POSTED

time Frame

7 days last post-baseline flare (during 24 weeks)

title

Amount of Rescue Medication Taken

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice