TriangleNCT00299130 · OUTCOME
Percent Change From Baseline in Patient's Global Assessment of Disease Activity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 24 and Week 48
What was measured
The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage 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=171, 166, 169]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | -14.0 | 48.94 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | -31.5 | 46.40 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | -29.1 | 54.43 | Not reported | Not reported | Not reported |
Week 48 [N=171, 166, 169]
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + MTX | -28.0 | 50.78 | Not reported | Not reported | Not reported |
| Rituximab 2 x 0.5 g + MTX | -39.7 | 40.53 | Not reported | Not reported | Not reported |
| Rituximab 2 x 1.0 g + MTX | -36.6 | 47.60 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 48.94
- value
- -14.0
- group Id
- OG001
- spread
- 46.40
- value
- -31.5
- group Id
- OG002
- spread
- 54.43
- value
- -29.1
- title
- Week 24 [N=171, 166, 169]
- categories
- measurements
- group Id
- OG000
- spread
- 50.78
- value
- -28.0
- group Id
- OG001
- spread
- 40.53
- value
- -39.7
- group Id
- OG002
- spread
- 47.60
- value
- -36.6
- title
- Week 48 [N=171, 166, 169]
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage 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
- Percent Change From Baseline in Patient's Global Assessment of Disease Activity
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice