Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
What was measured
The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that "there is pain", patient states "there is pain and winces", and patient states "there is pain, winces, and withdraws" on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported.
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. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
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
113
Triamcinolone Acetonide 40 mg
115
Reported measurements
TENDERNESS - No pain (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
33.6
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
26.4
Not reported
Not reported
Not reported
Not reported
Pain (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
56.6
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
51.8
Not reported
Not reported
Not reported
Not reported
Pain and winces (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
8.0
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
17.3
Not reported
Not reported
Not reported
Not reported
Pain,winces,withdraws (Core) [N=113,110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
1.8
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
4.5
Not reported
Not reported
Not reported
Not reported
SWELLING - No swelling (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
38.1
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
30.0
Not reported
Not reported
Not reported
Not reported
Palpable (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
38.9
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
35.5
Not reported
Not reported
Not reported
Not reported
Visible (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
21.2
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
29.1
Not reported
Not reported
Not reported
Not reported
Bulging beyond joint margin (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
1.8
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
5.5
Not reported
Not reported
Not reported
Not reported
ERYTHEMA - Absent (Core) [N=112, 109]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
78.6
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
65.1
Not reported
Not reported
Not reported
Not reported
Present (Core) [N=112, 109]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
21.4
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
34.9
Not reported
Not reported
Not reported
Not reported
TENDERNESS - No pain (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
82.8
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
85.0
Not reported
Not reported
Not reported
Not reported
Pain (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
17.2
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
13.8
Not reported
Not reported
Not reported
Not reported
Pain and winces (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
0.0
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
1.3
Not reported
Not reported
Not reported
Not reported
Pain,winces,withdraws (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
0.0
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
0.0
Not reported
Not reported
Not reported
Not reported
SWELLING - No swelling (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
88.5
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
93.8
Not reported
Not reported
Not reported
Not reported
Palpable (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
8.0
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
5.0
Not reported
Not reported
Not reported
Not reported
Visible (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
3.4
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
1.3
Not reported
Not reported
Not reported
Not reported
Bulging beyond joint margin (24 week)[N=87,80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
0.0
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
0.0
Not reported
Not reported
Not reported
Not reported
ERYTHEMA - Absent (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
98.9
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
100
Not reported
Not reported
Not reported
Not reported
Present (24 weeks) [N=87, 80]
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Canakinumab 150 mg
1.1
Not reported
Not reported
Not reported
Not reported
Triamcinolone Acetonide 40 mg
0.0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
33.6
group Id
OG001
value
26.4
title
TENDERNESS - No pain (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
56.6
group Id
OG001
value
51.8
title
Pain (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
8.0
group Id
OG001
value
17.3
title
Pain and winces (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
1.8
group Id
OG001
value
4.5
title
Pain,winces,withdraws (Core) [N=113,110]
categories
measurements
group Id
OG000
value
38.1
group Id
OG001
value
30.0
title
SWELLING - No swelling (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
38.9
group Id
OG001
value
35.5
title
Palpable (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
21.2
group Id
OG001
value
29.1
title
Visible (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
1.8
group Id
OG001
value
5.5
title
Bulging beyond joint margin (Core) [N=113, 110]
categories
measurements
group Id
OG000
value
78.6
group Id
OG001
value
65.1
title
ERYTHEMA - Absent (Core) [N=112, 109]
categories
measurements
group Id
OG000
value
21.4
group Id
OG001
value
34.9
title
Present (Core) [N=112, 109]
categories
measurements
group Id
OG000
value
82.8
group Id
OG001
value
85.0
title
TENDERNESS - No pain (24 weeks) [N=87, 80]
categories
measurements
group Id
OG000
value
17.2
group Id
OG001
value
13.8
title
Pain (24 weeks) [N=87, 80]
denoms
counts
group Id
OG000
value
113
group Id
OG001
value
115
units
Participants
description
The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that "there is pain", patient states "there is pain and winces", and patient states "there is pain, winces, and withdraws" on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported.
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
NUMBER
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. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
reporting Status
POSTED
time Frame
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
title
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
Triangle