TriangleNCT00299104 · OUTCOME
Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Weeks 52, Week 104
What was measured
The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement. Means are adjusted for baseline value, Rheumatoid Factor status and region.
Analysis population: Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. "n" in each of the categories is the number of participants with data available for analyses at the given time point.
Groups in this outcome
Placebo + Methotrexate
Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
Rituximab (0.5 g x 2) + Methotrexate
Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
Rituximab (1.0 g x 2) + Methotrexate
Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
| Group | Source count |
|---|---|
| Placebo + Methotrexate | 249 |
| Rituximab (0.5 g x 2) + Methotrexate | 249 |
| Rituximab (1.0 g x 2) + Methotrexate | 250 |
Reported measurements
Week 52 (n=239,236,241)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Methotrexate | 6.689 | 13.1160 | Not reported | Not reported | Not reported |
| Rituximab (0.5 g x 2) + Methotrexate | 7.718 | 11.8903 | Not reported | Not reported | Not reported |
| Rituximab (1.0 g x 2) + Methotrexate | 8.167 | 12.1709 | Not reported | Not reported | Not reported |
Week 104 (n= 240,236,242)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Methotrexate | 6.295 | 13.9813 | Not reported | Not reported | Not reported |
| Rituximab (0.5 g x 2) + Methotrexate | 7.617 | 12.0793 | Not reported | Not reported | Not reported |
| Rituximab (1.0 g x 2) + Methotrexate | 9.066 | 12.5325 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.1160
- value
- 6.689
- group Id
- OG001
- spread
- 11.8903
- value
- 7.718
- group Id
- OG002
- spread
- 12.1709
- value
- 8.167
- title
- Week 52 (n=239,236,241)
- categories
- measurements
- group Id
- OG000
- spread
- 13.9813
- value
- 6.295
- group Id
- OG001
- spread
- 12.0793
- value
- 7.617
- group Id
- OG002
- spread
- 12.5325
- value
- 9.066
- title
- Week 104 (n= 240,236,242)
- denoms
- counts
- group Id
- OG000
- value
- 249
- group Id
- OG001
- value
- 249
- group Id
- OG002
- value
- 250
- units
- Participants
- description
- The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement. Means are adjusted for baseline value, Rheumatoid Factor status and region.
- dispersion Type
- Standard Deviation
- groups
- description
- Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
- id
- OG000
- title
- Placebo + Methotrexate
- description
- Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
- id
- OG001
- title
- Rituximab (0.5 g x 2) + Methotrexate
- description
- Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
- id
- OG002
- title
- Rituximab (1.0 g x 2) + Methotrexate
- param Type
- MEAN
- population Description
- Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. "n" in each of the categories is the number of participants with data available for analyses at the given time point.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 52, Week 104
- title
- Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice