TriangleNCT00299130 · OUTCOME
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
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
- Baseline and Week 24
What was measured
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: * an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, * an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.
Analysis population: Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.
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 | 172 |
| Rituximab 2 x 0.5 g + MTX | 167 |
| Rituximab 2 x 1.0 g + MTX | 170 |
Reported measurements
No Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 66.3 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 33.5 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 37.1 | Not reported | Not reported | Not reported | Not reported |
Moderate Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 29.1 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 49.1 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 51.2 | Not reported | Not reported | Not reported | Not reported |
Good Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 4.7 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 17.4 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 11.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 66.3
- group Id
- OG001
- value
- 33.5
- group Id
- OG002
- value
- 37.1
- title
- No Response
- categories
- measurements
- group Id
- OG000
- value
- 29.1
- group Id
- OG001
- value
- 49.1
- group Id
- OG002
- value
- 51.2
- title
- Moderate Response
- categories
- measurements
- group Id
- OG000
- value
- 4.7
- group Id
- OG001
- value
- 17.4
- group Id
- OG002
- value
- 11.8
- title
- Good Response
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: * an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, * an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1.
- 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
- NUMBER
- population Description
- Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 24
- title
- Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice