TriangleNCT00299104 · OUTCOME
Change From Baseline in Modified Sharp Erosion Score at Week 52
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 and week 52
What was measured
Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.
Analysis population: Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation 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 | 232 |
| Rituximab (0.5 g x 2) + Methotrexate | 239 |
| Rituximab (1.0 g x 2) + Methotrexate | 244 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Methotrexate | 0.738 | 2.0480 | Not reported | Not reported | Not reported |
| Rituximab (0.5 g x 2) + Methotrexate | 0.453 | 1.2065 | Not reported | Not reported | Not reported |
| Rituximab (1.0 g x 2) + Methotrexate | 0.233 | 0.6252 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Description
- Comparing all three treatment groups
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0004
- p Value Comment
- The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Kruskal-Wallis
- ci Pct Value
- 95
- group Description
- Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1194
- p Value Comment
- The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Van-Elteren
- ci Pct Value
- 95
- group Description
- Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0001
- p Value Comment
- The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Van-Elteren
Complete source fields
- analyses
- ci Pct Value
- 95
- group Description
- Comparing all three treatment groups
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0004
- p Value Comment
- The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Kruskal-Wallis
- ci Pct Value
- 95
- group Description
- Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1194
- p Value Comment
- The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Van-Elteren
- ci Pct Value
- 95
- group Description
- Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0001
- p Value Comment
- The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.
- statistical Method
- Van-Elteren
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.0480
- value
- 0.738
- group Id
- OG001
- spread
- 1.2065
- value
- 0.453
- group Id
- OG002
- spread
- 0.6252
- value
- 0.233
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 239
- group Id
- OG002
- value
- 244
- units
- Participants
- description
- Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.
- 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
- Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.
- reporting Status
- POSTED
- time Frame
- Baseline and week 52
- title
- Change From Baseline in Modified Sharp Erosion Score at Week 52
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice