TriangleNCT01080131 · OUTCOME
Time to First Intake of Rescue Medication
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
What was measured
Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: * Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. * If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication. Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).
Analysis population: For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.
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 | Source count |
|---|---|
| Canakinumab 150 mg | 112 |
| Triamcinolone Acetonide 40 mg | 114 |
Reported measurements
Baseline flare [N= 112, 114]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | NA | Not reported | 24 | NA | The data were not estimable as \<50% patients took rescue medication |
| Triamcinolone Acetonide 40 mg | 37.5 | Not reported | 14 | NA | Upper bound did not cross the median value hence the upper limit was not estimable. |
Last post-baseline flare [N=25, 46]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 32 | Not reported | 8.0 | NA | Upper bound did not cross the median value hence the upper limit was not estimable. |
| Triamcinolone Acetonide 40 mg | NA | Not reported | 12.0 | NA | The data were not estimable as \<50% patients took rescue medication |
Complete source fields
- classes
- categories
- measurements
- comment
- The data were not estimable as \<50% patients took rescue medication
- group Id
- OG000
- lower Limit
- 24
- upper Limit
- NA
- value
- NA
- comment
- Upper bound did not cross the median value hence the upper limit was not estimable.
- group Id
- OG001
- lower Limit
- 14
- upper Limit
- NA
- value
- 37.5
- title
- Baseline flare [N= 112, 114]
- categories
- measurements
- comment
- Upper bound did not cross the median value hence the upper limit was not estimable.
- group Id
- OG000
- lower Limit
- 8.0
- upper Limit
- NA
- value
- 32
- comment
- The data were not estimable as \<50% patients took rescue medication
- group Id
- OG001
- lower Limit
- 12.0
- upper Limit
- NA
- value
- NA
- title
- Last post-baseline flare [N=25, 46]
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: * Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. * If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication. Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.
- reporting Status
- POSTED
- time Frame
- For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
- title
- Time to First Intake of Rescue Medication
- type
- SECONDARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice