TriangleNCT00422383 · OUTCOME
Change From BL in Complement C3 Protein Level in g/L
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- g/L
- Interval / dispersion
- Standard Deviation
- Time frame
- BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
What was measured
The LLN of C3 protein was defined as \<0.9 g/L.
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 | Source count |
|---|---|
| Rituximab Low Dose + Methotrexate | 120 |
| Rituximab Escalated Dose + Methotrexate | 105 |
| Rituximab High Dose + Methotrexate | 84 |
Reported measurements
BL Postdose (n=119,102,84)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0469 | 0.17761 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0563 | 0.16277 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.0802 | 0.12774 | Not reported | Not reported | Not reported |
Day 15 Predose (n=120,105,80)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0423 | 0.20915 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0143 | 0.17514 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.0773 | 0.17876 | Not reported | Not reported | Not reported |
Day 15 Postdose (n=118,104,79)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0413 | 0.18365 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0235 | 0.19255 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.1094 | 0.21860 | Not reported | Not reported | Not reported |
Wk 4 (n=118,105,78)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0137 | 0.22743 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | 0.0279 | 0.20724 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.0596 | 0.18186 | Not reported | Not reported | Not reported |
BL Pre Retreatment (n=115,98,83)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0621 | 0.21365 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0225 | 0.20578 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.0864 | 0.19814 | Not reported | Not reported | Not reported |
BL Post Retreatment (n=113,97,78)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0889 | 0.21974 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0673 | 0.21150 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.1395 | 0.21823 | Not reported | Not reported | Not reported |
Day 15 Pre Retreatment (n=115,97,81)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.0953 | 0.20329 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0580 | 0.26221 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.1374 | 0.19296 | Not reported | Not reported | Not reported |
Day 15 Post Retreatment (n=113,99,82)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | -0.1048 | 0.20255 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | -0.0979 | 0.23505 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | -0.1533 | 0.21412 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.17761
- value
- -0.0469
- group Id
- OG001
- spread
- 0.16277
- value
- -0.0563
- group Id
- OG002
- spread
- 0.12774
- value
- -0.0802
- title
- BL Postdose (n=119,102,84)
- categories
- measurements
- group Id
- OG000
- spread
- 0.20915
- value
- -0.0423
- group Id
- OG001
- spread
- 0.17514
- value
- -0.0143
- group Id
- OG002
- spread
- 0.17876
- value
- -0.0773
- title
- Day 15 Predose (n=120,105,80)
- categories
- measurements
- group Id
- OG000
- spread
- 0.18365
- value
- -0.0413
- group Id
- OG001
- spread
- 0.19255
- value
- -0.0235
- group Id
- OG002
- spread
- 0.21860
- value
- -0.1094
- title
- Day 15 Postdose (n=118,104,79)
- categories
- measurements
- group Id
- OG000
- spread
- 0.22743
- value
- -0.0137
- group Id
- OG001
- spread
- 0.20724
- value
- 0.0279
- group Id
- OG002
- spread
- 0.18186
- value
- -0.0596
- title
- Wk 4 (n=118,105,78)
- categories
- measurements
- group Id
- OG000
- spread
- 0.21365
- value
- -0.0621
- group Id
- OG001
- spread
- 0.20578
- value
- -0.0225
- group Id
- OG002
- spread
- 0.19814
- value
- -0.0864
- title
- BL Pre Retreatment (n=115,98,83)
- categories
- measurements
- group Id
- OG000
- spread
- 0.21974
- value
- -0.0889
- group Id
- OG001
- spread
- 0.21150
- value
- -0.0673
- group Id
- OG002
- spread
- 0.21823
- value
- -0.1395
- title
- BL Post Retreatment (n=113,97,78)
- categories
- measurements
- group Id
- OG000
- spread
- 0.20329
- value
- -0.0953
- group Id
- OG001
- spread
- 0.26221
- value
- -0.0580
- group Id
- OG002
- spread
- 0.19296
- value
- -0.1374
- title
- Day 15 Pre Retreatment (n=115,97,81)
- categories
- measurements
- group Id
- OG000
- spread
- 0.20255
- value
- -0.1048
- group Id
- OG001
- spread
- 0.23505
- value
- -0.0979
- group Id
- OG002
- spread
- 0.21412
- value
- -0.1533
- title
- Day 15 Post Retreatment (n=113,99,82)
- denoms
- counts
- group Id
- OG000
- value
- 120
- group Id
- OG001
- value
- 105
- group Id
- OG002
- value
- 84
- units
- Participants
- description
- The LLN of C3 protein was defined as \<0.9 g/L.
- 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 Complement C3 Protein Level in g/L
- type
- SECONDARY
- unit Of Measure
- g/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice