NCT01029652 · OUTCOME
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)
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
- 7 days post dose (randomization), 24 weeks post-dose
What was measured
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).
Analysis population: Full Analysis Set includes all patients that received 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
None (7 days post-dose) [N= 110, 107]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 32.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 28.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild (7 days post-dose) [N= 110, 107]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 48.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 41.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate (7 days post-dose) [N= 110, 107]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 16.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 16.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe (7 days post-dose) [N= 110, 107]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 2.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 12.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Extreme (7 days post-dose) [N= 110, 107]
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 | 1.9 | Not reported | Not reported | Not reported | Not reported |
|---|
None (24 weeks post-dose) [N= 85, 78]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 47.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 46.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild (24 weeks post-dose) [N= 85, 78]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 38.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 37.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate (24 weeks post-dose) [N= 85, 78]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 12.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 15.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe (24 weeks post-dose) [N= 85, 78]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 1.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 1.3 | Not reported | Not reported | Not reported | Not reported |
|---|
Extreme (24 weeks post-dose) [N= 85, 78]
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 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32.7
- group Id
- OG001
- value
- 28.0
- title
- None (7 days post-dose) [N= 110, 107]
- categories
- measurements
- group Id
- OG000
- value
- 48.2
- group Id
- OG001
- value
- 41.1
- title
- Mild (7 days post-dose) [N= 110, 107]
- categories
- measurements
- group Id
- OG000
- value
- 16.4
- group Id
- OG001
- value
- 16.8
- title
- Moderate (7 days post-dose) [N= 110, 107]
- categories
- measurements
- group Id
- OG000
- value
- 2.7
- group Id
- OG001
- value
- 12.1
- title
- Severe (7 days post-dose) [N= 110, 107]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 1.9
- title
- Extreme (7 days post-dose) [N= 110, 107]
- categories
- measurements
- group Id
- OG000
- value
- 47.1
- group Id
- OG001
- value
- 46.2
- title
- None (24 weeks post-dose) [N= 85, 78]
- categories
- measurements
- group Id
- OG000
- value
- 38.8
- group Id
- OG001
- value
- 37.2
- title
- Mild (24 weeks post-dose) [N= 85, 78]
- categories
- measurements
- group Id
- OG000
- value
- 12.9
- group Id
- OG001
- value
- 15.4
- title
- Moderate (24 weeks post-dose) [N= 85, 78]
- categories
- measurements
- group Id
- OG000
- value
- 1.2
- group Id
- OG001
- value
- 1.3
- title
- Severe (24 weeks post-dose) [N= 85, 78]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- Extreme (24 weeks post-dose) [N= 85, 78]
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).
- 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
- Full Analysis Set includes all patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.
- reporting Status
- POSTED
- time Frame
- 7 days post dose (randomization), 24 weeks post-dose
- title
- Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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