NCT01029652 · 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 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 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 assessments (pain intensity \[Visual Analog Scale and Likert scale\] 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 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.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization 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 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
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
Very good (Core) [N=113,110]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 16.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 15.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Good (Core) [N=113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 47.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 30.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Fair (Core) [N= 113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 26.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 32.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Poor (Core) [N= 113, 110]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 7.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 14.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Very poor (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 | 7.3 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good ( 24 weeks) [N=87, 79]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 43.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 27.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Good (24 weeks) [N=87, 79]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 50.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 50.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Fair (24 weeks) [N=87, 79]
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Canakinumab 150 mg | 5.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triamcinolone Acetonide 40 mg | 17.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Poor (24 weeks) [N=87, 79]
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 | 3.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Poor (24 weeks) [N=87, 79]
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
- 16.8
- group Id
- OG001
- value
- 15.5
- title
- Very good (Core) [N=113,110]
- categories
- measurements
- group Id
- OG000
- value
- 47.8
- group Id
- OG001
- value
- 30.0
- title
- Good (Core) [N=113, 110]
- categories
- measurements
- group Id
- OG000
- value
- 26.5
- group Id
- OG001
- value
- 32.7
- title
- Fair (Core) [N= 113, 110]
- categories
- measurements
- group Id
- OG000
- value
- 7.1
- group Id
- OG001
- value
- 14.5
- title
- Poor (Core) [N= 113, 110]
- categories
- measurements
- group Id
- OG000
- value
- 1.8
- group Id
- OG001
- value
- 7.3
- title
- Very poor (Core) [N=113, 110]
- categories
- measurements
- group Id
- OG000
- value
- 43.7
- group Id
- OG001
- value
- 27.8
- title
- Very Good ( 24 weeks) [N=87, 79]
- categories
- measurements
- group Id
- OG000
- value
- 50.6
- group Id
- OG001
- value
- 50.6
- title
- Good (24 weeks) [N=87, 79]
- categories
- measurements
- group Id
- OG000
- value
- 5.7
- group Id
- OG001
- value
- 17.7
- title
- Fair (24 weeks) [N=87, 79]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 3.8
- title
- Poor (24 weeks) [N=87, 79]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- Very Poor (24 weeks) [N=87, 79]
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 115
- 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 assessments (pain intensity \[Visual Analog Scale and Likert scale\] and patient's global assessment of response to treatment).
- 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.
After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization 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 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
- 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 Global Assessment of Response to Treatment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle