TriangleNCT00468546 · OUTCOME
Mean Change From Baseline in Disease Activity Score of 28 Joints at Week 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- From Baseline (Day 1) to Week 24
What was measured
The disease activity score (DAS28) is an evaluation index of rheumatoid arthritis. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC-28 joints, 2. SJC -28 joints, 3. ESR or CRP measurement, 4. Participant's judgement on his own overall health (global health \[GH\]) status expressed by a VAS (0 \[no disease activity\] to 100 \[maximum disease activity\]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. Change from Baseline = difference between the score at Week 24 and the score at Baseline.
Analysis population: The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
Groups in this outcome
Placebo Plus Methotrexate
Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
Rituximab Plus Methotrexate
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
| Group | Source count |
|---|---|
| Placebo Plus Methotrexate | 201 |
| Rituximab Plus Methotrexate | 298 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Plus Methotrexate | -0.4 | 1.17 | Not reported | Not reported | Not reported |
| Rituximab Plus Methotrexate | -1.9 | 1.60 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.17
- value
- -0.4
- group Id
- OG001
- spread
- 1.60
- value
- -1.9
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 298
- units
- Participants
- description
- The disease activity score (DAS28) is an evaluation index of rheumatoid arthritis. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC-28 joints, 2. SJC -28 joints, 3. ESR or CRP measurement, 4. Participant's judgement on his own overall health (global health \[GH\]) status expressed by a VAS (0 \[no disease activity\] to 100 \[maximum disease activity\]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. Change from Baseline = difference between the score at Week 24 and the score at Baseline.
- dispersion Type
- Standard Deviation
- groups
- description
- Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
- id
- OG000
- title
- Placebo Plus Methotrexate
- description
- Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
- id
- OG001
- title
- Rituximab Plus Methotrexate
- param Type
- MEAN
- population Description
- The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) to Week 24
- title
- Mean Change From Baseline in Disease Activity Score of 28 Joints at Week 24
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice