TriangleNCT00886769 · OUTCOME
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
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
- Baseline, Day 15, Day 29
What was measured
Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% 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 CRP (mg/L)
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 | 83.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 9.8 | Not reported | Not reported | Not reported | Not reported |
Day 29
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 79.1 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 9.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 83.7
- group Id
- OG001
- value
- 9.8
- title
- Day 15
- categories
- measurements
- group Id
- OG000
- value
- 79.1
- group Id
- OG001
- value
- 9.8
- title
- Day 29
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% 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 CRP (mg/L)
- 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 Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice