TriangleNCT01356602 · OUTCOME
Physician's Assessment of Swelling
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Partipants
- Interval / dispersion
- Not reported
- Time frame
- 72 hours
What was measured
The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.
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
No swelling
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 60.8 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 55.2 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 51.2 | Not reported | Not reported | Not reported | Not reported |
Palpable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 26.9 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 25.6 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 15.7 | Not reported | Not reported | Not reported | Not reported |
Visible
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 10.8 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 17.6 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 24.8 | Not reported | Not reported | Not reported | Not reported |
Bulging beyond the joint margins
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 1.5 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 1.6 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 8.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60.8
- group Id
- OG001
- value
- 55.2
- group Id
- OG002
- value
- 51.2
- title
- No swelling
- categories
- measurements
- group Id
- OG000
- value
- 26.9
- group Id
- OG001
- value
- 25.6
- group Id
- OG002
- value
- 15.7
- title
- Palpable
- categories
- measurements
- group Id
- OG000
- value
- 10.8
- group Id
- OG001
- value
- 17.6
- group Id
- OG002
- value
- 24.8
- title
- Visible
- categories
- measurements
- group Id
- OG000
- value
- 1.5
- group Id
- OG001
- value
- 1.6
- group Id
- OG002
- value
- 8.3
- title
- Bulging beyond the joint margins
- denoms
- counts
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 129
- group Id
- OG002
- value
- 129
- units
- Participants
- description
- The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.
- 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
- 72 hours
- title
- Physician's Assessment of Swelling
- type
- SECONDARY
- unit Of Measure
- Percentage of Partipants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice