TriangleNCT00266227 · OUTCOME
ACRn in Retreated Subjects at Week 48
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 48
What was measured
The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). A positive ACRn Score indicates an 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 | 317 |
| Arm B: Placebo Re-treatment | 157 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Rituximab Re-treatment | 22.1 | 45.29 | Not reported | Not reported | Not reported |
| Arm B: Placebo Re-treatment | 10.7 | 62.08 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 45.29
- value
- 22.1
- group Id
- OG001
- spread
- 62.08
- value
- 10.7
- denoms
- counts
- group Id
- OG000
- value
- 317
- group Id
- OG001
- value
- 157
- units
- Participants
- description
- The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). A positive ACRn Score indicates an 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
- ACRn in Retreated Subjects at Week 48
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice