NCT01080131 · OUTCOME
Physician's Global Assessment of Response to Treatment
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 24-weeks post-dose.
What was measured
The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment).
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 available for this endpoint at the specified time point.
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 | 112 |
|---|
| Triamcinolone Acetonide 40 mg | 114 |
|---|
Reported measurements
72 hours - Very good [N= 107, 109]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 43.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 25.7 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Good [N= 107, 109]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 43.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 35.8 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Fair [N= 107, 109]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 11.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 26.6 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Poor [N= 107, 109]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 2.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 6.4 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Very poor [N= 107, 109]
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 | 5.5 | Not reported | Not reported | Not reported | Not reported |
|---|
24 weeks - Very good [N=79, 71]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 77.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 66.2 | Not reported | Not reported | Not reported | Not reported |
|---|
24 weeks - Good [N=79, 71]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 16.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 29.6 | Not reported | Not reported | Not reported | Not reported |
|---|
24 weeks - Fair [N=79, 71]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 5.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 4.2 | Not reported | Not reported | Not reported | Not reported |
|---|
24 weeks - Poor [N=79, 71]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 1.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
24 weeks - Very poor [N=79, 71]
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
- 43.0
- group Id
- OG001
- value
- 25.7
- title
- 72 hours - Very good [N= 107, 109]
- categories
- measurements
- group Id
- OG000
- value
- 43.0
- group Id
- OG001
- value
- 35.8
- title
- 72 hours - Good [N= 107, 109]
- categories
- measurements
- group Id
- OG000
- value
- 11.2
- group Id
- OG001
- value
- 26.6
- title
- 72 hours - Fair [N= 107, 109]
- categories
- measurements
- group Id
- OG000
- value
- 2.8
- group Id
- OG001
- value
- 6.4
- title
- 72 hours - Poor [N= 107, 109]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 5.5
- title
- 72 hours - Very poor [N= 107, 109]
- categories
- measurements
- group Id
- OG000
- value
- 77.2
- group Id
- OG001
- value
- 66.2
- title
- 24 weeks - Very good [N=79, 71]
- categories
- measurements
- group Id
- OG000
- value
- 16.5
- group Id
- OG001
- value
- 29.6
- title
- 24 weeks - Good [N=79, 71]
- categories
- measurements
- group Id
- OG000
- value
- 5.1
- group Id
- OG001
- value
- 4.2
- title
- 24 weeks - Fair [N=79, 71]
- categories
- measurements
- group Id
- OG000
- value
- 1.3
- group Id
- OG001
- value
- 0.0
- title
- 24 weeks - Poor [N=79, 71]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- 24 weeks - Very poor [N=79, 71]
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment).
- 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
- 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 available for this endpoint at the specified time point.
- reporting Status
- POSTED
- time Frame
- 72 hours post-dose and 24-weeks post-dose.
- title
- Physician's Global Assessment of Response to Treatment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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