TriangleNCT00422383 · OUTCOME
Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 48
What was measured
ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (visual analog assessment \[VAS\]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing
Analysis population: ITT-M2 population
Groups in this outcome
Rituximab Low Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab Escalated Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab High Dose + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
| Group | Source count |
|---|---|
| Rituximab Low Dose + Methotrexate | 134 |
| Rituximab Escalated Dose + Methotrexate | 119 |
| Rituximab High Dose + Methotrexate | 93 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | 64.2 | Not reported | 56.0 | 72.0 | Not reported |
| Rituximab Escalated Dose + Methotrexate | 63.9 | Not reported | 55.0 | 72.0 | Not reported |
| Rituximab High Dose + Methotrexate | 72.0 | Not reported | 63.0 | 81.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.10
- estimate Comment
- Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8156
- param Type
- Weighted Difference
- param Value
- -0.01
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Lower Limit
- -0.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- estimate Comment
- Analysis stratified by region, prior biologic use, RF status, and treatment.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2419
- param Type
- Weighted Difference
- param Value
- 0.07
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.10
- estimate Comment
- Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.8156
- param Type
- Weighted Difference
- param Value
- -0.01
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- ci Lower Limit
- -0.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.19
- estimate Comment
- Analysis stratified by region, prior biologic use, RF status, and treatment.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2419
- param Type
- Weighted Difference
- param Value
- 0.07
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56.0
- upper Limit
- 72.0
- value
- 64.2
- group Id
- OG001
- lower Limit
- 55.0
- upper Limit
- 72.0
- value
- 63.9
- group Id
- OG002
- lower Limit
- 63.0
- upper Limit
- 81.0
- value
- 72.0
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 119
- group Id
- OG002
- value
- 93
- units
- Participants
- description
- ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (visual analog assessment \[VAS\]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG000
- title
- Rituximab Low Dose + Methotrexate
- description
- Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG001
- title
- Rituximab Escalated Dose + Methotrexate
- description
- Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG002
- title
- Rituximab High Dose + Methotrexate
- param Type
- NUMBER
- population Description
- ITT-M2 population
- reporting Status
- POSTED
- time Frame
- Week 48
- title
- Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice