TriangleNCT01356602 · OUTCOME
Time to the First New Gouty Arthritis Flare
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
- 12 weeks
What was measured
Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients 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. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
Analysis population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Groups in this outcome
Canakinumab, Pre-filled Syringes (PFS)
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
Canakinumab, Lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
| Group | Source count |
|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 131 |
| Canakinumab, Lyophilizate (LYO) | 129 |
| Triamcinolone Acetonide | 129 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | NA | Not reported | NA | NA | Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated. |
| Canakinumab, Lyophilizate (LYO) | NA | Not reported | NA | NA | Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated. |
| Triamcinolone Acetonide | NA | Not reported | NA | NA | Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- comment
- Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 129
- group Id
- OG002
- value
- 129
- units
- Participants
- description
- Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients 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. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
- id
- OG000
- title
- Canakinumab, Pre-filled Syringes (PFS)
- description
- The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
- id
- OG001
- title
- Canakinumab, Lyophilizate (LYO)
- description
- The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
- id
- OG002
- title
- Triamcinolone Acetonide
- param Type
- MEDIAN
- population Description
- Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
- reporting Status
- POSTED
- time Frame
- 12 weeks
- title
- Time to the First New Gouty Arthritis Flare
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice