NCT01080131 · OUTCOME
Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (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 for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
What was measured
Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.
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. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.
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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
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.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
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 | 25 |
|---|
| Triamcinolone Acetonide 40 mg | 46 |
|---|
Reported measurements
6 hours post-dose
Values in mm · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 57.4 | 3.07 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 59.1 | 2.26 | 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 | 50.7 | 4.24 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 53.3 | 3.12 | 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 | 46.2 | 4.74 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 43.8 | 3.49 | 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 | 42.3 | 4.96 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 34.2 | 3.65 | 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 | 37.0 | 5.12 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 26.1 | 3.77 | 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 | 31.3 | 4.75 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 23.4 | 3.49 | 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 | 29.0 | 5.11 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 21.6 | 3.76 | 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 | 28.1 | 5.04 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 20.5 | 3.71 | 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 | 24.1 | 5.03 | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 19.1 | 3.70 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.07
- value
- 57.4
- group Id
- OG001
- spread
- 2.26
- value
- 59.1
- title
- 6 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 4.24
- value
- 50.7
- group Id
- OG001
- spread
- 3.12
- value
- 53.3
- title
- 12 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 4.74
- value
- 46.2
- group Id
- OG001
- spread
- 3.49
- value
- 43.8
- title
- 24 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 4.96
- value
- 42.3
- group Id
- OG001
- spread
- 3.65
- value
- 34.2
- title
- 48 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 5.12
- value
- 37.0
- group Id
- OG001
- spread
- 3.77
- value
- 26.1
- title
- 72 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 4.75
- value
- 31.3
- group Id
- OG001
- spread
- 3.49
- value
- 23.4
- title
- 4 days post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 5.11
- value
- 29.0
- group Id
- OG001
- spread
- 3.76
- value
- 21.6
- title
- 5 days post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 5.04
- value
- 28.1
- group Id
- OG001
- spread
- 3.71
- value
- 20.5
- title
- 6 days post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 5.03
- value
- 24.1
- group Id
- OG001
- spread
- 3.70
- value
- 19.1
- title
- 7 days post-dose
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 46
- units
- Participants
- description
- Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
- 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.
In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
- id
- OG001
- title
- Triamcinolone Acetonide 40 mg
- param Type
- LEAST_SQUARES_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. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.
- reporting Status
- POSTED
- time Frame
- 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
- title
- Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)
- type
- SECONDARY
- unit Of Measure
- mm
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Preserved source evidence · Not medical advice
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