TriangleNCT01356602 · OUTCOME
Physician's Assessment of Tenderness
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- 72 hours
What was measured
The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.
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 pain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 40.0 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 29.8 | Not reported | Not reported | Not reported | Not reported |
There is pain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 43.1 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 52.8 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 47.1 | Not reported | Not reported | Not reported | Not reported |
There is pain and winces
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 5.4 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 6.4 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 14.0 | Not reported | Not reported | Not reported | Not reported |
There is pain, winces and withdraws
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | 1.5 | Not reported | Not reported | Not reported | Not reported |
| Canakinumab, Lyophilizate (LYO) | 0.8 | Not reported | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide | 9.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 50.0
- group Id
- OG001
- value
- 40.0
- group Id
- OG002
- value
- 29.8
- title
- No pain
- categories
- measurements
- group Id
- OG000
- value
- 43.1
- group Id
- OG001
- value
- 52.8
- group Id
- OG002
- value
- 47.1
- title
- There is pain
- categories
- measurements
- group Id
- OG000
- value
- 5.4
- group Id
- OG001
- value
- 6.4
- group Id
- OG002
- value
- 14.0
- title
- There is pain and winces
- categories
- measurements
- group Id
- OG000
- value
- 1.5
- group Id
- OG001
- value
- 0.8
- group Id
- OG002
- value
- 9.1
- title
- There is pain, winces and withdraws
- 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 tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.
- 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 Tenderness
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice