TriangleNCT00299130 · OUTCOME
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 24 and Week 48
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. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
Analysis population: Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
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
Week 24 [N=172, 165, 170]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | -14.7 | 38.41 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | -26.9 | 40.89 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | -23.4 | 49.52 | Not reported | Not reported | Not reported |
Week 48 [N=172, 165, 170]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | -22.6 | 39.63 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | -30.2 | 41.64 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | -30.6 | 39.95 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 38.41
- value
- -14.7
- group Id
- OG001
- spread
- 40.89
- value
- -26.9
- group Id
- OG002
- spread
- 49.52
- value
- -23.4
- title
- Week 24 [N=172, 165, 170]
- categories
- measurements
- group Id
- OG000
- spread
- 39.63
- value
- -22.6
- group Id
- OG001
- spread
- 41.64
- value
- -30.2
- group Id
- OG002
- spread
- 39.95
- value
- -30.6
- title
- Week 48 [N=172, 165, 170]
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 167
- 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. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
- 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, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24 and Week 48
- title
- Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice