TriangleNCT00889863 · OUTCOME
Part II: 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
- LEAST_SQUARES_MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Start Part II (Week 32), End Part II (total duration - 88 Weeks)
What was measured
CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact-emotional, Parental impact-time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.
Analysis population: Full Analysis Set Part II-patients aged 5-18 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.
Placebo
Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 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 | 39 |
| Placebo | 37 |
Reported measurements
Physical Health Score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 3.9 | 2.54 | Not reported | Not reported | Not reported |
| Placebo | -0.3 | 2.53 | Not reported | Not reported | Not reported |
Psychosocial Health Score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab | 2.5 | 1.88 | Not reported | Not reported | Not reported |
| Placebo | -0.5 | 1.86 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.54
- value
- 3.9
- group Id
- OG001
- spread
- 2.53
- value
- -0.3
- title
- Physical Health Score
- categories
- measurements
- group Id
- OG000
- spread
- 1.88
- value
- 2.5
- group Id
- OG001
- spread
- 1.86
- value
- -0.5
- title
- Psychosocial Health Score
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact-emotional, Parental impact-time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.
- dispersion Type
- Standard Error
- 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
- description
- Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 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
- OG001
- title
- Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Full Analysis Set Part II-patients aged 5-18 years.
- reporting Status
- POSTED
- time Frame
- Start Part II (Week 32), End Part II (total duration - 88 Weeks)
- title
- Part II: 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