TriangleNCT00299130 · OUTCOME
Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened 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
The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement. Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22. An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22. A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22.
Analysis population: Intent-to-treat population including participants with available data. LOCF was used.
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 | 165 |
| Rituximab 2 x 1.0 g + MTX | 170 |
Reported measurements
Improved
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 47.7 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 66.1 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 58.2 | Not reported | Not reported | Not reported | Not reported |
No change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 32.6 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 23.6 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 32.4 | Not reported | Not reported | Not reported | Not reported |
Worsened
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 19.8 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 10.3 | Not reported | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 9.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 47.7
- group Id
- OG001
- value
- 66.1
- group Id
- OG002
- value
- 58.2
- title
- Improved
- categories
- measurements
- group Id
- OG000
- value
- 32.6
- group Id
- OG001
- value
- 23.6
- group Id
- OG002
- value
- 32.4
- title
- No change
- categories
- measurements
- group Id
- OG000
- value
- 19.8
- group Id
- OG001
- value
- 10.3
- group Id
- OG002
- value
- 9.4
- title
- Worsened
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 165
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement. Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22. An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22. A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22.
- 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 including participants with available data. LOCF was used.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 24
- title
- Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice