TriangleNCT00299130 · OUTCOME
Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 24 and Week 48
What was measured
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A positive percentage change from baseline score indicates an improvement.
Analysis population: Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
Groups in this outcome
Placebo + MTX
Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 0.5 g + MTX
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 1.0 g + MTX
Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
| Group | Source count |
|---|---|
| Placebo + MTX | 172 |
| Rituximab 2 x 0.5 g + MTX | 167 |
| Rituximab 2 x 1.0 g + MTX | 170 |
Reported measurements
Physical Component: Week 24 [N=147, 152, 155]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 11.1 | 27.63 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 23.7 | 31.63 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 22.8 | 33.09 | Not reported | Not reported | Not reported |
Physical Component: Week 48 [N=154, 154, 162]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 21.3 | 30.99 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 26.4 | 35.81 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 27.4 | 31.93 | Not reported | Not reported | Not reported |
Mental Component: Week 24 [N=147, 152, 155]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 8.4 | 29.43 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 12.6 | 29.13 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 19.6 | 56.64 | Not reported | Not reported | Not reported |
Mental Component: Week 48 [N=154, 154, 162]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 12.7 | 30.52 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 18.4 | 38.87 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 18.7 | 57.34 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 27.63
- value
- 11.1
- group Id
- OG001
- spread
- 31.63
- value
- 23.7
- group Id
- OG002
- spread
- 33.09
- value
- 22.8
- title
- Physical Component: Week 24 [N=147, 152, 155]
- categories
- measurements
- group Id
- OG000
- spread
- 30.99
- value
- 21.3
- group Id
- OG001
- spread
- 35.81
- value
- 26.4
- group Id
- OG002
- spread
- 31.93
- value
- 27.4
- title
- Physical Component: Week 48 [N=154, 154, 162]
- categories
- measurements
- group Id
- OG000
- spread
- 29.43
- value
- 8.4
- group Id
- OG001
- spread
- 29.13
- value
- 12.6
- group Id
- OG002
- spread
- 56.64
- value
- 19.6
- title
- Mental Component: Week 24 [N=147, 152, 155]
- categories
- measurements
- group Id
- OG000
- spread
- 30.52
- value
- 12.7
- group Id
- OG001
- spread
- 38.87
- value
- 18.4
- group Id
- OG002
- spread
- 57.34
- value
- 18.7
- title
- Mental Component: Week 48 [N=154, 154, 162]
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A positive percentage change from baseline score indicates an improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG000
- title
- Placebo + MTX
- description
- Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG001
- title
- Rituximab 2 x 0.5 g + MTX
- description
- Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG002
- title
- Rituximab 2 x 1.0 g + MTX
- param Type
- MEAN
- population Description
- Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24 and Week 48
- title
- Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)
- type
- SECONDARY
- unit Of Measure
- percent change
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Preserved source evidence · Not medical advice