TriangleNCT00721123 · OUTCOME
Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Joints
- Interval / dispersion
- Standard Deviation
- Time frame
- through 264 Weeks
What was measured
Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement. A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC).
Analysis population: All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.
Groups in this outcome
Week 24
Participants with scores at 24 weeks post-baseline.
Week 48
Participants with scores at 48 weeks post-baseline.
Week 108
Participants with scores at 108 weeks post-baseline.
Week 156
Participants with scores at 156 weeks post-baseline.
Week 204
Participants with scores at 204 weeks post-baseline.
Week 264
Participants with scores at 264 weeks post-baseline.
| Group | Source count |
|---|---|
| Week 24 | 532 |
| Week 48 | 506 |
| Week 108 | 454 |
| Week 156 | 422 |
| Week 204 | 405 |
| Week 264 | 371 |
Reported measurements
Swollen Joint Count (SJC)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Week 24 | -11.7 | 11.50 | Not reported | Not reported | Not reported |
| Week 48 | -13.6 | 11.04 | Not reported | Not reported | Not reported |
| Week 108 | -15.6 | 11.51 | Not reported | Not reported | Not reported |
| Week 156 | -16.2 | 11.46 | Not reported | Not reported | Not reported |
| Week 204 | -16.2 | 11.48 | Not reported | Not reported | Not reported |
| Week 264 | -16.5 | 11.26 | Not reported | Not reported | Not reported |
Tender Joint Count (TJC)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Week 24 | -17.4 | 14.82 | Not reported | Not reported | Not reported |
| Week 48 | -20.3 | 15.12 | Not reported | Not reported | Not reported |
| Week 108 | -23.1 | 15.82 | Not reported | Not reported | Not reported |
| Week 156 | -23.8 | 16.14 | Not reported | Not reported | Not reported |
| Week 204 | -23.8 | 15.89 | Not reported | Not reported | Not reported |
| Week 264 | -24.8 | 16.37 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.50
- value
- -11.7
- group Id
- OG001
- spread
- 11.04
- value
- -13.6
- group Id
- OG002
- spread
- 11.51
- value
- -15.6
- group Id
- OG003
- spread
- 11.46
- value
- -16.2
- group Id
- OG004
- spread
- 11.48
- value
- -16.2
- group Id
- OG005
- spread
- 11.26
- value
- -16.5
- title
- Swollen Joint Count (SJC)
- categories
- measurements
- group Id
- OG000
- spread
- 14.82
- value
- -17.4
- group Id
- OG001
- spread
- 15.12
- value
- -20.3
- group Id
- OG002
- spread
- 15.82
- value
- -23.1
- group Id
- OG003
- spread
- 16.14
- value
- -23.8
- group Id
- OG004
- spread
- 15.89
- value
- -23.8
- group Id
- OG005
- spread
- 16.37
- value
- -24.8
- title
- Tender Joint Count (TJC)
- denoms
- counts
- group Id
- OG000
- value
- 532
- group Id
- OG001
- value
- 506
- group Id
- OG002
- value
- 454
- group Id
- OG003
- value
- 422
- group Id
- OG004
- value
- 405
- group Id
- OG005
- value
- 371
- units
- Participants
- description
- Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement. A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with scores at 24 weeks post-baseline.
- id
- OG000
- title
- Week 24
- description
- Participants with scores at 48 weeks post-baseline.
- id
- OG001
- title
- Week 48
- description
- Participants with scores at 108 weeks post-baseline.
- id
- OG002
- title
- Week 108
- description
- Participants with scores at 156 weeks post-baseline.
- id
- OG003
- title
- Week 156
- description
- Participants with scores at 204 weeks post-baseline.
- id
- OG004
- title
- Week 204
- description
- Participants with scores at 264 weeks post-baseline.
- id
- OG005
- title
- Week 264
- param Type
- MEAN
- population Description
- All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.
- reporting Status
- POSTED
- time Frame
- through 264 Weeks
- title
- Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks
- type
- SECONDARY
- unit Of Measure
- Joints
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice