TriangleNCT00468546 · OUTCOME
Mean Change From Baseline of Short Form 36 Total Scores at Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- From Baseline (Day 1) to Week 24
What was measured
The Short Form (SF)-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Transforming and standardizing these domains leads to the calculation of the physical component summary and mental component summary measures. Scores on each item were summed and averaged (range 0 \[worst\] to 100 \[best\]); increase in score from baseline indicated improvement. Change from Baseline = difference between the score at Week 24 and the score at Baseline.
Analysis population: The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.
Groups in this outcome
Placebo Plus Methotrexate
Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
Rituximab Plus Methotrexate
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
| Group | Source count |
|---|---|
| Placebo Plus Methotrexate | 197 |
| Rituximab Plus Methotrexate | 294 |
Reported measurements
Physical score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Plus Methotrexate | 0.9 | 5.65 | Not reported | Not reported | Not reported |
| Rituximab Plus Methotrexate | 5.8 | 8.47 | Not reported | Not reported | Not reported |
Mental health score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Plus Methotrexate | 1.3 | 9.43 | Not reported | Not reported | Not reported |
| Rituximab Plus Methotrexate | 4.7 | 11.75 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.65
- value
- 0.9
- group Id
- OG001
- spread
- 8.47
- value
- 5.8
- title
- Physical score
- categories
- measurements
- group Id
- OG000
- spread
- 9.43
- value
- 1.3
- group Id
- OG001
- spread
- 11.75
- value
- 4.7
- title
- Mental health score
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 294
- units
- Participants
- description
- The Short Form (SF)-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Transforming and standardizing these domains leads to the calculation of the physical component summary and mental component summary measures. Scores on each item were summed and averaged (range 0 \[worst\] to 100 \[best\]); increase in score from baseline indicated improvement. Change from Baseline = difference between the score at Week 24 and the score at Baseline.
- dispersion Type
- Standard Deviation
- groups
- description
- Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
- id
- OG000
- title
- Placebo Plus Methotrexate
- description
- Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
- id
- OG001
- title
- Rituximab Plus Methotrexate
- param Type
- MEAN
- population Description
- The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) to Week 24
- title
- Mean Change From Baseline of Short Form 36 Total Scores at Week 24
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice