TriangleNCT00299130 · OUTCOME
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Week 24
What was measured
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * Erythrocyte sedimentation rate (ESR); * Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Analysis population: Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.
Groups in this outcome
Placebo + MTX
Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 0.5 g + MTX
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 1.0 g + MTX
Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
| Group | Source count |
|---|---|
| Placebo + MTX | 171 |
| Rituximab 2 x 0.5 g + MTX | 166 |
| Rituximab 2 x 1.0 g + MTX | 168 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | -0.76 | 1.304 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | -1.71 | 1.334 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | -1.68 | 1.342 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.304
- value
- -0.76
- group Id
- OG001
- spread
- 1.334
- value
- -1.71
- group Id
- OG002
- spread
- 1.342
- value
- -1.68
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 166
- group Id
- OG002
- value
- 168
- units
- Participants
- description
- The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * Erythrocyte sedimentation rate (ESR); * Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG000
- title
- Placebo + MTX
- description
- Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG001
- title
- Rituximab 2 x 0.5 g + MTX
- description
- Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG002
- title
- Rituximab 2 x 1.0 g + MTX
- param Type
- MEAN
- population Description
- Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 24
- title
- Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice