TriangleNCT01080131 · OUTCOME
Time to the First New Gout Flare During 24 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to the end of the first extension period (24 weeks).
What was measured
Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had: * Flare in joint, not a previously affected joint (at baseline or during study) * Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
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.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | NA | Not reported | NA | NA | Not estimable due to the low number of events at the time of the assessment (24 weeks). |
| Triamcinolone Acetonide 40 mg | 146 | Not reported | 94.0 | NA | Not estimable due to the low number of events at the time of the assessment (24 weeks). |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to the low number of events at the time of the assessment (24 weeks).
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to the low number of events at the time of the assessment (24 weeks).
- group Id
- OG001
- lower Limit
- 94.0
- upper Limit
- NA
- value
- 146
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 114
- units
- Participants
- description
- Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had: * Flare in joint, not a previously affected joint (at baseline or during study) * Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
- 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
- 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.
- reporting Status
- POSTED
- time Frame
- From randomization to the end of the first extension period (24 weeks).
- title
- Time to the First New Gout Flare During 24 Weeks
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice