TriangleNCT00299104 · OUTCOME
Change From Baseline in the Modified Total Sharp Score at Week 104
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 104
What was measured
The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.
Analysis population: Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.
Groups in this outcome
Placebo + Methotrexate
Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
Rituximab (0.5 g x 2) + Methotrexate
Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
Rituximab (1.0 g x 2) + Methotrexate
Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
| Group | Source count |
|---|---|
| Placebo + Methotrexate | 229 |
| Rituximab (0.5 g x 2) + Methotrexate | 238 |
| Rituximab (1.0 g x 2) + Methotrexate | 243 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Methotrexate | 1.948 | 5.5782 | Not reported | Not reported | Not reported |
| Rituximab (0.5 g x 2) + Methotrexate | 0.761 | 2.6181 | Not reported | Not reported | Not reported |
| Rituximab (1.0 g x 2) + Methotrexate | 0.406 | 1.4312 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Description
- Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Van-Elteren
Complete source fields
- analyses
- ci Pct Value
- 95
- group Description
- Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- p Value Comment
- This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Van-Elteren
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.5782
- value
- 1.948
- group Id
- OG001
- spread
- 2.6181
- value
- 0.761
- group Id
- OG002
- spread
- 1.4312
- value
- 0.406
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 238
- group Id
- OG002
- value
- 243
- units
- Participants
- description
- The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.
- dispersion Type
- Standard Deviation
- groups
- description
- Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
- id
- OG000
- title
- Placebo + Methotrexate
- description
- Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
- id
- OG001
- title
- Rituximab (0.5 g x 2) + Methotrexate
- description
- Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
- id
- OG002
- title
- Rituximab (1.0 g x 2) + Methotrexate
- param Type
- MEAN
- population Description
- Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 104
- title
- Change From Baseline in the Modified Total Sharp Score at Week 104
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice