TriangleNCT00889863 · OUTCOME
Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Score on a scale
- Interval / dispersion
- Full Range
- Time frame
- Baseline, End of Part I ( Week 32)
What was measured
The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact - emotional, Parental impact - time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.
Analysis population: Participants from the Full Analysis Set Part I-age 5 to 18 years.
Groups in this outcome
Canakinumab
In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
| Group | Source count |
|---|---|
| Canakinumab | 125 |
Reported measurements
Physical Health Score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 21.8050 | 16.10377 | -21.554 | 62.309 | Not reported |
Psychosocial Health Score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 8.2223 | 11.50688 | -21.710 | 38.854 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -21.554
- spread
- 16.10377
- upper Limit
- 62.309
- value
- 21.8050
- title
- Physical Health Score
- categories
- measurements
- group Id
- OG000
- lower Limit
- -21.710
- spread
- 11.50688
- upper Limit
- 38.854
- value
- 8.2223
- title
- Psychosocial Health Score
- denoms
- counts
- group Id
- OG000
- value
- 125
- units
- Participants
- description
- The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact - emotional, Parental impact - time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.
- dispersion Type
- Full Range
- groups
- description
- In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
- id
- OG000
- title
- Canakinumab
- param Type
- MEDIAN
- population Description
- Participants from the Full Analysis Set Part I-age 5 to 18 years.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Part I ( Week 32)
- title
- Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice