NCT01080131 · OUTCOME
Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)
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
- LEAST_SQUARES_MEAN
- Unit
- mm
- Interval / dispersion
- Standard Error
- Time frame
- 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)
What was measured
Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
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
6 hours post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 58.7 | 1.94 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 60.3 | 1.96 | Not reported | Not reported | Not reported |
|---|
12 hours post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 50.8 | 2.16 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 52.0 | 2.18 | Not reported | Not reported | Not reported |
|---|
24 hours post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 39.1 | 2.39 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 45.0 | 2.41 | Not reported | Not reported | Not reported |
|---|
48 hours post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 29.5 | 2.45 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 38.9 | 2.48 | Not reported | Not reported | Not reported |
|---|
72 hours post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 22.1 | 2.33 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 31.9 | 2.35 | Not reported | Not reported | Not reported |
|---|
4 days post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 19.2 | 2.25 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 27.7 | 2.27 | Not reported | Not reported | Not reported |
|---|
5 days post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 16.4 | 2.23 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 25.4 | 2.25 | Not reported | Not reported | Not reported |
|---|
6 days post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 14.3 | 2.20 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 22.3 | 2.22 | Not reported | Not reported | Not reported |
|---|
7 days post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 14.0 | 2.18 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 19.5 | 2.20 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.94
- value
- 58.7
- group Id
- OG001
- spread
- 1.96
- value
- 60.3
- title
- 6 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.16
- value
- 50.8
- group Id
- OG001
- spread
- 2.18
- value
- 52.0
- title
- 12 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.39
- value
- 39.1
- group Id
- OG001
- spread
- 2.41
- value
- 45.0
- title
- 24 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.45
- value
- 29.5
- group Id
- OG001
- spread
- 2.48
- value
- 38.9
- title
- 48 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.33
- value
- 22.1
- group Id
- OG001
- spread
- 2.35
- value
- 31.9
- title
- 72 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.25
- value
- 19.2
- group Id
- OG001
- spread
- 2.27
- value
- 27.7
- title
- 4 days post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.23
- value
- 16.4
- group Id
- OG001
- spread
- 2.25
- value
- 25.4
- title
- 5 days post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.20
- value
- 14.3
- group Id
- OG001
- spread
- 2.22
- value
- 22.3
- title
- 6 days post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.18
- value
- 14.0
- group Id
- OG001
- spread
- 2.20
- value
- 19.5
- title
- 7 days post-dose
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
- dispersion Type
- Standard Error
- 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
- LEAST_SQUARES_MEAN
- 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
- 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)
- title
- Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)
- type
- SECONDARY
- unit Of Measure
- mm
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Preserved source evidence · Not medical advice
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