TriangleNCT01550003 · OUTCOME
Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
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
- 95% Confidence Interval
- Time frame
- Week 16
What was measured
PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * C-reactive protein (CRP)
Analysis population: Full analysis set (FAS): all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
Groups in this outcome
Any CZP Dose - Weight Group: 10 - <20 kg
Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
Any CZP Dose - Weight Group: 20 - <40 kg
Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
Any CZP Dose - Weight Group: >=40 kg
Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
| Group | Source count |
|---|---|
| Any CZP Dose - Weight Group: 10 - <20 kg | 18 |
| Any CZP Dose - Weight Group: 20 - <40 kg | 63 |
| Any CZP Dose - Weight Group: >=40 kg | 112 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Any CZP Dose - Weight Group: 10 - <20 kg | 83.3 | Not reported | 58.6 | 96.4 | Not reported |
| Any CZP Dose - Weight Group: 20 - <40 kg | 77.8 | Not reported | 65.5 | 87.3 | Not reported |
| Any CZP Dose - Weight Group: >=40 kg | 79.5 | Not reported | 70.8 | 86.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58.6
- upper Limit
- 96.4
- value
- 83.3
- group Id
- OG001
- lower Limit
- 65.5
- upper Limit
- 87.3
- value
- 77.8
- group Id
- OG002
- lower Limit
- 70.8
- upper Limit
- 86.5
- value
- 79.5
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 63
- group Id
- OG002
- value
- 112
- units
- Participants
- description
- PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * C-reactive protein (CRP)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
- id
- OG000
- title
- Any CZP Dose - Weight Group: 10 - <20 kg
- description
- Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
- id
- OG001
- title
- Any CZP Dose - Weight Group: 20 - <40 kg
- description
- Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
- id
- OG002
- title
- Any CZP Dose - Weight Group: >=40 kg
- param Type
- NUMBER
- population Description
- Full analysis set (FAS): all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90.
- reporting Status
- POSTED
- time Frame
- Week 16
- title
- Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice