NCT01029652 · OUTCOME
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
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 , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
What was measured
Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
Analysis population: Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Groups in this outcome
Randomized to Canakinumab and Re-treated With Canakinumab
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.
Randomized to Triamcinolone and Switched to Canakinumab
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 |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 69 |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 39 |
|---|
Reported measurements
Excellent (72 hours post dose) (n=60, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 15.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 19.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Good (72 hours post dose) (n=60, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 26.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 44.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Acceptable (72 hours post dose) (n=60, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 27.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Slight (72 hours post dose) (n=60, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 6.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 2.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Poor (72 hours post dose) (n=60, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 1.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 5.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Excellent (7 days post dose) (n=68, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 23.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 27.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Good (7 days post dose) (n=68, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 41.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 52.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Acceptable (7 days post dose) (n=68, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 27.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 16.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Slight (7 days post dose) (n=68, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 7.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 2.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Poor (7 days post dose) (n=68, 36)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Randomized to Canakinumab and Re-treated With Canakinumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Randomized to Triamcinolone and Switched to Canakinumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15.0
- group Id
- OG001
- value
- 19.4
- title
- Excellent (72 hours post dose) (n=60, 36)
- categories
- measurements
- group Id
- OG000
- value
- 26.7
- group Id
- OG001
- value
- 44.4
- title
- Good (72 hours post dose) (n=60, 36)
- categories
- measurements
- group Id
- OG000
- value
- 50.0
- group Id
- OG001
- value
- 27.8
- title
- Acceptable (72 hours post dose) (n=60, 36)
- categories
- measurements
- group Id
- OG000
- value
- 6.7
- group Id
- OG001
- value
- 2.8
- title
- Slight (72 hours post dose) (n=60, 36)
- categories
- measurements
- group Id
- OG000
- value
- 1.7
- group Id
- OG001
- value
- 5.6
- title
- Poor (72 hours post dose) (n=60, 36)
- categories
- measurements
- group Id
- OG000
- value
- 23.5
- group Id
- OG001
- value
- 27.8
- title
- Excellent (7 days post dose) (n=68, 36)
- categories
- measurements
- group Id
- OG000
- value
- 41.2
- group Id
- OG001
- value
- 52.8
- title
- Good (7 days post dose) (n=68, 36)
- categories
- measurements
- group Id
- OG000
- value
- 27.9
- group Id
- OG001
- value
- 16.7
- title
- Acceptable (7 days post dose) (n=68, 36)
- categories
- measurements
- group Id
- OG000
- value
- 7.4
- group Id
- OG001
- value
- 2.8
- title
- Slight (7 days post dose) (n=68, 36)
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- Poor (7 days post dose) (n=68, 36)
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.
- 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
- Randomized to Canakinumab and Re-treated With Canakinumab
- 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
- Randomized to Triamcinolone and Switched to Canakinumab
- param Type
- NUMBER
- population Description
- Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
- reporting Status
- POSTED
- time Frame
- 72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)
- title
- Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice
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