TriangleNCT00299130 · OUTCOME
Time to Repletion of Peripheral CD19+ B-cells
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)
What was measured
Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower.
Analysis population: Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period.
Groups in this outcome
Rituximab 2 x 0.5 g + MTX
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
Rituximab 2 x 1.0 g + MTX
Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
| Group | Source count |
|---|---|
| Rituximab 2 x 0.5 g + MTX | 80 |
| Rituximab 2 x 1.0 g + MTX | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab 2 x 0.5 g + MTX | 110.3 | Not reported | 89.6 | 148.3 | Not reported |
| Rituximab 2 x 1.0 g + MTX | 109.6 | Not reported | 94.1 | 134.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 89.6
- upper Limit
- 148.3
- value
- 110.3
- group Id
- OG001
- lower Limit
- 94.1
- upper Limit
- 134.9
- value
- 109.6
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 43
- units
- Participants
- description
- Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG000
- title
- Rituximab 2 x 0.5 g + MTX
- description
- Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG001
- title
- Rituximab 2 x 1.0 g + MTX
- param Type
- MEDIAN
- population Description
- Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period.
- reporting Status
- POSTED
- time Frame
- Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)
- title
- Time to Repletion of Peripheral CD19+ B-cells
- type
- POST_HOC
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice