TriangleNCT02097745 · OUTCOME
Change From Baseline in the Total Genant-modified Sharp Score at Year 5
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline to Year 5
What was measured
The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.
Analysis population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
Groups in this outcome
Placebo
Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
Rituximab
Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
| Group | Source count |
|---|---|
| Placebo | 79 |
| Rituximab | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 5.446 | 8.4701 | Not reported | Not reported | Not reported |
| Rituximab | 3.202 | 6.5538 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.4701
- value
- 5.446
- group Id
- OG001
- spread
- 6.5538
- value
- 3.202
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.
- dispersion Type
- Standard Deviation
- groups
- description
- Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
- id
- OG000
- title
- Placebo
- description
- Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
- id
- OG001
- title
- Rituximab
- param Type
- MEAN
- population Description
- Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Baseline to Year 5
- title
- Change From Baseline in the Total Genant-modified Sharp Score at Year 5
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice