TriangleNCT00299104 · OUTCOME
Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52
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, Week 52
What was measured
DAS28-ESR is calculated from the following formula: (0.56 \* TJC) + (0.28 \* SJC) + (0.70 \* ln ESR) + (0.014 \* GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient's global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR \< 2.6).
Analysis population: Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.
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 | 244 |
| Rituximab (0.5 g x 2) + Methotrexate | 247 |
| Rituximab (1.0 g x 2) + Methotrexate | 248 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Methotrexate | -2.33 | 1.691 | Not reported | Not reported | Not reported |
| Rituximab (0.5 g x 2) + Methotrexate | -3.35 | 1.663 | Not reported | Not reported | Not reported |
| Rituximab (1.0 g x 2) + Methotrexate | -3.46 | 1.640 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.691
- value
- -2.33
- group Id
- OG001
- spread
- 1.663
- value
- -3.35
- group Id
- OG002
- spread
- 1.640
- value
- -3.46
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 247
- group Id
- OG002
- value
- 248
- units
- Participants
- description
- DAS28-ESR is calculated from the following formula: (0.56 \* TJC) + (0.28 \* SJC) + (0.70 \* ln ESR) + (0.014 \* GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient's global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR \< 2.6).
- 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
- Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 52
- title
- Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice