NCT00422383 · OUTCOME
Change From BL in Peripheral CD4+ T Cell Count
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04
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, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
What was measured
Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.
Analysis population: SAP, n = number of participants assessed for the given parameter at the specified timepoint.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab Low Dose + Methotrexate | 122 |
|---|
| Rituximab Escalated Dose + Methotrexate | 107 |
|---|
| Rituximab High Dose + Methotrexate | 88 |
|---|
Reported measurements
BL Postdose (n=115,106,82)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | -744.6 | 454.55 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | -738.1 | 393.02 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -801.2 | 416.45 | Not reported | Not reported | Not reported |
|---|
Day 15 Predose (n=122,107,84)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 24.3 | 355.22 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 38.9 | 306.89 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 36.0 | 359.92 | Not reported | Not reported | Not reported |
|---|
Day 15 Postdose (n=116,102,86)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | -732.2 | 449.99 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | -696.5 | 392.37 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -749.4 | 401.01 | Not reported | Not reported | Not reported |
|---|
Wk 4 (n=122,105,84)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | -16.1 | 330.20 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | -4.2 | 345.57 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -36.2 | 368.83 | Not reported | Not reported | Not reported |
|---|
Wk 8 (n=121,105,87)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 7.9 | 418.85 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 84.1 | 370.64 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -4.4 | 343.31 | Not reported | Not reported | Not reported |
|---|
Wk 16 (n=117,105,88)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | -24.3 | 377.76 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 64.0 | 349.16 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -33.4 | 407.52 | Not reported | Not reported | Not reported |
|---|
Wk 24 (n=109,100,82)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 72.6 | 395.29 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 37.3 | 312.15 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -0.7 | 336.19 | Not reported | Not reported | Not reported |
|---|
Wk 28 (n=115,94,84)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 42.8 | 446.65 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 13.5 | 276.55 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | 7.4 | 377.73 | Not reported | Not reported | Not reported |
|---|
Wk 32 (n=116,99,85)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 38.4 | 419.78 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 39.2 | 305.18 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -8.4 | 337.42 | Not reported | Not reported | Not reported |
|---|
Wk 40 (n=113,96,81)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | 14.9 | 375.97 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 39.5 | 356.89 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -6.4 | 331.87 | Not reported | Not reported | Not reported |
|---|
Wk 48 (n=110,96,80)
Values in cells/µL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab Low Dose + Methotrexate | -8.5 | 399.48 | Not reported | Not reported | Not reported |
|---|
| Rituximab Escalated Dose + Methotrexate | 15.2 | 320.98 | Not reported | Not reported | Not reported |
|---|
| Rituximab High Dose + Methotrexate | -10.1 | 366.44 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 454.55
- value
- -744.6
- group Id
- OG001
- spread
- 393.02
- value
- -738.1
- group Id
- OG002
- spread
- 416.45
- value
- -801.2
- title
- BL Postdose (n=115,106,82)
- categories
- measurements
- group Id
- OG000
- spread
- 355.22
- value
- 24.3
- group Id
- OG001
- spread
- 306.89
- value
- 38.9
- group Id
- OG002
- spread
- 359.92
- value
- 36.0
- title
- Day 15 Predose (n=122,107,84)
- categories
- measurements
- group Id
- OG000
- spread
- 449.99
- value
- -732.2
- group Id
- OG001
- spread
- 392.37
- value
- -696.5
- group Id
- OG002
- spread
- 401.01
- value
- -749.4
- title
- Day 15 Postdose (n=116,102,86)
- categories
- measurements
- group Id
- OG000
- spread
- 330.20
- value
- -16.1
- group Id
- OG001
- spread
- 345.57
- value
- -4.2
- group Id
- OG002
- spread
- 368.83
- value
- -36.2
- title
- Wk 4 (n=122,105,84)
- categories
- measurements
- group Id
- OG000
- spread
- 418.85
- value
- 7.9
- group Id
- OG001
- spread
- 370.64
- value
- 84.1
- group Id
- OG002
- spread
- 343.31
- value
- -4.4
- title
- Wk 8 (n=121,105,87)
- categories
- measurements
- group Id
- OG000
- spread
- 377.76
- value
- -24.3
- group Id
- OG001
- spread
- 349.16
- value
- 64.0
- group Id
- OG002
- spread
- 407.52
- value
- -33.4
- title
- Wk 16 (n=117,105,88)
- categories
- measurements
- group Id
- OG000
- spread
- 395.29
- value
- 72.6
- group Id
- OG001
- spread
- 312.15
- value
- 37.3
- group Id
- OG002
- spread
- 336.19
- value
- -0.7
- title
- Wk 24 (n=109,100,82)
- categories
- measurements
- group Id
- OG000
- spread
- 446.65
- value
- 42.8
- group Id
- OG001
- spread
- 276.55
- value
- 13.5
- group Id
- OG002
- spread
- 377.73
- value
- 7.4
- title
- Wk 28 (n=115,94,84)
- categories
- measurements
- group Id
- OG000
- spread
- 419.78
- value
- 38.4
- group Id
- OG001
- spread
- 305.18
- value
- 39.2
- group Id
- OG002
- spread
- 337.42
- value
- -8.4
- title
- Wk 32 (n=116,99,85)
- categories
- measurements
- group Id
- OG000
- spread
- 375.97
- value
- 14.9
- group Id
- OG001
- spread
- 356.89
- value
- 39.5
- group Id
- OG002
- spread
- 331.87
- value
- -6.4
- title
- Wk 40 (n=113,96,81)
- categories
- measurements
- group Id
- OG000
- spread
- 399.48
- value
- -8.5
- group Id
- OG001
- spread
- 320.98
- value
- 15.2
- group Id
- OG002
- spread
- 366.44
- value
- -10.1
- title
- Wk 48 (n=110,96,80)
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 88
- units
- Participants
- description
- Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.
- 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
- param Type
- MEAN
- population Description
- SAP, n = number of participants assessed for the given parameter at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
- title
- Change From BL in Peripheral CD4+ T Cell Count
- type
- SECONDARY
- unit Of Measure
- cells/µL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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