TriangleNCT00266227 · OUTCOME
Change From Baseline in Disease Activity Score (DAS28-CRP) 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
- Baseline, Week 48
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 C-Reactive Protein (CRP) 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 Re-treatment
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 Re-treatment
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 Re-treatment | 316 |
| Arm B: Placebo Re-treatment | 157 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Rituximab Re-treatment | -1.8 | 1.4 | Not reported | Not reported | Not reported |
| Arm B: Placebo Re-treatment | -1.5 | 1.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.4
- value
- -1.8
- group Id
- OG001
- spread
- 1.5
- value
- -1.5
- denoms
- counts
- group Id
- OG000
- value
- 316
- 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 C-Reactive Protein (CRP) 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 Re-treatment
- 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 Re-treatment
- 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
- Baseline, Week 48
- title
- Change From Baseline in Disease Activity Score (DAS28-CRP) 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