TriangleNCT00422383 · OUTCOME
Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- cells/µL
- Interval / dispersion
- Standard Deviation
- Time frame
- BL
What was measured
Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.
Analysis population: ITT-M2 population. 7, 8, 3, 1, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, High Dose, Placebo, and Decreased Dose groups, respectively.
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.
Rituximab/Placebo + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, 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. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
Rituximab Decreased Dose + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 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. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
| Group | Source count |
|---|---|
| Rituximab Low Dose + Methotrexate | 127 |
| Rituximab Escalated Dose + Methotrexate | 111 |
| Rituximab High Dose + Methotrexate | 90 |
| Rituximab/Placebo + Methotrexate | 5 |
| Rituximab Decreased Dose + Methotrexate | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | 183.6 | 142.31 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | 168.9 | 94.98 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | 205.3 | 171.91 | Not reported | Not reported | Not reported |
| Rituximab/Placebo + Methotrexate | 318.2 | 174.62 | Not reported | Not reported | Not reported |
| Rituximab Decreased Dose + Methotrexate | 235.4 | 112.56 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 142.31
- value
- 183.6
- group Id
- OG001
- spread
- 94.98
- value
- 168.9
- group Id
- OG002
- spread
- 171.91
- value
- 205.3
- group Id
- OG003
- spread
- 174.62
- value
- 318.2
- group Id
- OG004
- spread
- 112.56
- value
- 235.4
- denoms
- counts
- group Id
- OG000
- value
- 127
- group Id
- OG001
- value
- 111
- group Id
- OG002
- value
- 90
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 23
- units
- Participants
- description
- Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.
- dispersion Type
- Standard Deviation
- 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
- description
- Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, 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. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
- id
- OG003
- title
- Rituximab/Placebo + Methotrexate
- description
- Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 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. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
- id
- OG004
- title
- Rituximab Decreased Dose + Methotrexate
- param Type
- MEAN
- population Description
- ITT-M2 population. 7, 8, 3, 1, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, High Dose, Placebo, and Decreased Dose groups, respectively.
- reporting Status
- POSTED
- time Frame
- BL
- title
- Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)
- type
- SECONDARY
- unit Of Measure
- cells/µL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice