NCT01080131 · OUTCOME

Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab

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: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

What was measured

The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Analysis population: Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

Groups in this outcome

Re-treated With Canakinumab 150 mg

Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.

Triam Switched to Canakinumab

Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.

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
Re-treated With Canakinumab 150 mg	62
Triam Switched to Canakinumab	41

Reported measurements

72 hours - Absent [N=56, 38]

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Re-treated With Canakinumab 150 mg	73.2	Not reported	Not reported	Not reported	Not reported
Triam Switched to Canakinumab	92.1	Not reported	Not reported	Not reported	Not reported

72 hours - Present [N=56, 38]

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Re-treated With Canakinumab 150 mg	26.8	Not reported	Not reported	Not reported	Not reported
Triam Switched to Canakinumab	7.9	Not reported	Not reported	Not reported	Not reported

7 days - Absent [N=58, 39]

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Re-treated With Canakinumab 150 mg	84.5	Not reported	Not reported	Not reported	Not reported
Triam Switched to Canakinumab	94.9	Not reported	Not reported	Not reported	Not reported

7 days - Present [N=58, 39]

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Re-treated With Canakinumab 150 mg	15.5	Not reported	Not reported	Not reported	Not reported
Triam Switched to Canakinumab	5.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
73.2
group Id
OG001
value
92.1
title
72 hours - Absent [N=56, 38]
categories
measurements
group Id
OG000
value
26.8
group Id
OG001
value
7.9
title
72 hours - Present [N=56, 38]
categories
measurements
group Id
OG000
value
84.5
group Id
OG001
value
94.9
title
7 days - Absent [N=58, 39]
categories
measurements
group Id
OG000
value
15.5
group Id
OG001
value
5.1
title
7 days - Present [N=58, 39]

denoms

counts
group Id
OG000
value
62
group Id
OG001
value
41
units
Participants

description

groups

description
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
id
OG000
title
Re-treated With Canakinumab 150 mg
description
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
id
OG001
title
Triam Switched to Canakinumab

param Type

NUMBER

population Description

Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.

reporting Status

POSTED

time Frame

72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.

title

Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice