TriangleNCT00299104 · OUTCOME
Percentage of Patients Without Radiographic Progression at Week 52
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage
- Interval / dispersion
- Not reported
- Time frame
- Baseline, Week 52
What was measured
Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) \<= 0. TMSS 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.
Analysis population: Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.
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 | 53.4 | Not reported | Not reported | Not reported | Not reported |
| Rituximab (0.5 g x 2) + Methotrexate | 57.7 | Not reported | Not reported | Not reported | Not reported |
| Rituximab (1.0 g x 2) + Methotrexate | 63.5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.05
- ci Pct Value
- 95
- ci Upper Limit
- 0.13
- group Description
- Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.3803
- p Value Comment
- This was a secondary endpoint in a hierarchical testing structure.
- param Type
- Mean Difference (Net)
- param Value
- 0.04
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 0.01
- ci Pct Value
- 95
- ci Upper Limit
- 0.18
- group Description
- Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0309
- p Value Comment
- This was a secondary endpoint in a hierarchical testing structure.
- param Type
- Mean Difference (Net)
- param Value
- 0.10
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -0.05
- ci Pct Value
- 95
- ci Upper Limit
- 0.13
- group Description
- Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.3803
- p Value Comment
- This was a secondary endpoint in a hierarchical testing structure.
- param Type
- Mean Difference (Net)
- param Value
- 0.04
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 0.01
- ci Pct Value
- 95
- ci Upper Limit
- 0.18
- group Description
- Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0309
- p Value Comment
- This was a secondary endpoint in a hierarchical testing structure.
- param Type
- Mean Difference (Net)
- param Value
- 0.10
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 53.4
- group Id
- OG001
- value
- 57.7
- group Id
- OG002
- value
- 63.5
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 239
- group Id
- OG002
- value
- 244
- units
- Participants
- description
- Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) \<= 0. TMSS 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.
- 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
- NUMBER
- population Description
- Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 52
- title
- Percentage of Patients Without Radiographic Progression at Week 52
- type
- SECONDARY
- unit Of Measure
- Percentage
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice