TriangleNCT01080131 · OUTCOME
SF 36 Physical Function Score at Week 12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Week 12
What was measured
SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.
Analysis population: Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.
Groups in this outcome
Canakinumab 150 mg
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Triamcinolone Acetonide 40 mg
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
| Group | Source count |
|---|---|
| Canakinumab 150 mg | 83 |
| Triamcinolone Acetonide 40 mg | 81 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Canakinumab 150 mg | 81.46 | 2.786 | Not reported | Not reported | Not reported |
| Triamcinolone Acetonide 40 mg | 78.75 | 2.820 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.786
- value
- 81.46
- group Id
- OG001
- spread
- 2.820
- value
- 78.75
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 81
- units
- Participants
- description
- SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.
- dispersion Type
- Standard Error
- groups
- description
- Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
- id
- OG000
- title
- Canakinumab 150 mg
- description
- Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
- id
- OG001
- title
- Triamcinolone Acetonide 40 mg
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Week 12
- title
- SF 36 Physical Function Score at Week 12
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice