TriangleNCT00266227 · OUTCOME
Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48
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
- 48 weeks
What was measured
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Analysis population: Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.
Groups in this outcome
Arm A: Rituximab Retreatment
1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
Arm B: Placebo Retreatment
1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
| Group | Source count |
|---|---|
| Arm A: Rituximab Retreatment | 312 |
| Arm B: Placebo Retreatment | 157 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Rituximab Retreatment | -2.1 | 1.55 | Not reported | Not reported | Not reported |
| Arm B: Placebo Retreatment | -1.8 | 1.69 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.7
- ci Pct Value
- 95
- ci Upper Limit
- -0.1
- group Description
- Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Mean Difference (Final Values)
- param Value
- -0.4
- statistical Comment
- Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -0.7
- ci Pct Value
- 95
- ci Upper Limit
- -0.1
- group Description
- Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Mean Difference (Final Values)
- param Value
- -0.4
- statistical Comment
- Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.55
- value
- -2.1
- group Id
- OG001
- spread
- 1.69
- value
- -1.8
- denoms
- counts
- group Id
- OG000
- value
- 312
- group Id
- OG001
- value
- 157
- units
- Participants
- description
- The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
- id
- OG000
- title
- Arm A: Rituximab Retreatment
- description
- 1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
- id
- OG001
- title
- Arm B: Placebo Retreatment
- param Type
- MEAN
- population Description
- Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.
- reporting Status
- POSTED
- time Frame
- 48 weeks
- title
- Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice