TriangleNCT00886769 · OUTCOME
Percentage of Patients Achieving the Adapted ACR Pediatric 100
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent of participants
- Interval / dispersion
- Not reported
- Time frame
- baseline, Day 15, Day 29
What was measured
Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation
Analysis population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.
Groups in this outcome
Canakinumab
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
| Group | Source count |
|---|---|
| Canakinumab | 43 |
| Placebo | 41 |
Reported measurements
Day 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 32.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
Day 29
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 32.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 2.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 32.6
- group Id
- OG001
- value
- 0
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- value
- 32.6
- group Id
- OG001
- value
- 2.4
- title
- Day 29
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation
- groups
- description
- Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
- id
- OG000
- title
- Canakinumab
- description
- Patients received a single dose matching placebo of canakinumab on day 1.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- baseline, Day 15, Day 29
- title
- Percentage of Patients Achieving the Adapted ACR Pediatric 100
- type
- SECONDARY
- unit Of Measure
- percent of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice