TriangleNCT00266227 · OUTCOME
Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Week 48
What was measured
The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.
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 | 21.1 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Placebo Re-treatment | 18.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21.1
- group Id
- OG001
- value
- 18.5
- denoms
- counts
- group Id
- OG000
- value
- 317
- group Id
- OG001
- value
- 157
- units
- Participants
- description
- The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.
- 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
- NUMBER
- 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
- Week 48
- title
- Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice