TriangleNCT01356602 · OUTCOME
Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Particpants
- Interval / dispersion
- Not reported
- 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.
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) | 12 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 12 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 52 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 52
- 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.
- 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
- NUMBER
- 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
- Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
- type
- SECONDARY
- unit Of Measure
- Particpants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice