TriangleNCT00299130 · OUTCOME
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 24 and Week 48
What was measured
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from baseline score indicates an improvement.
Analysis population: Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
Groups in this outcome
Placebo + MTX
Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX 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 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 |
|---|---|
| Placebo + MTX | 172 |
| Rituximab 2 x 0.5 g + MTX | 167 |
| Rituximab 2 x 1.0 g + MTX | 170 |
Reported measurements
Week 24 [N=170, 165, 168]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 2.661 | 9.5093 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 5.564 | 9.7438 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 6.398 | 10.2143 | Not reported | Not reported | Not reported |
Week 48 [N=170, 165, 169]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | 5.506 | 10.9651 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | 6.269 | 9.7495 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | 6.203 | 9.7833 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.5093
- value
- 2.661
- group Id
- OG001
- spread
- 9.7438
- value
- 5.564
- group Id
- OG002
- spread
- 10.2143
- value
- 6.398
- title
- Week 24 [N=170, 165, 168]
- categories
- measurements
- group Id
- OG000
- spread
- 10.9651
- value
- 5.506
- group Id
- OG001
- spread
- 9.7495
- value
- 6.269
- group Id
- OG002
- spread
- 9.7833
- value
- 6.203
- title
- Week 48 [N=170, 165, 169]
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from baseline score indicates an improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX 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
- Placebo + MTX
- 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
- OG001
- 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
- OG002
- title
- Rituximab 2 x 1.0 g + MTX
- param Type
- MEAN
- population Description
- Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 24 and Week 48
- title
- Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores
- type
- SECONDARY
- unit Of Measure
- scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice