NCT00468546 · OUTCOME
Mean Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score, Genant-modified Sharp Total Score, and Erosion Score
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25
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
- From Baseline (Day 1) to Weeks (W) 24, 56, and 104
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. For all the three radiograph assessment, the minimum score is 0. A higher score indicates more damage and a negative change score indicates improvement. The change in score is to be calculated as: Change from Baseline = difference between the score at Weeks 24, 56, or 104 and the score at Baseline.
Analysis population: The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
Groups in this outcome
Placebo Plus Methotrexate
Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
Rituximab Plus Methotrexate
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo Plus Methotrexate | 201 |
|---|
| Rituximab Plus Methotrexate | 298 |
|---|
Reported measurements
Sharp-Genant total score, W24, n = 201, 298
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -4.3 | 24.09 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -1.2 | 20.90 | Not reported | Not reported | Not reported |
|---|
Sharp-Genant total score, W56, n = 184, 273
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 2.31 | 5.283 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | 1.00 | 2.751 | Not reported | Not reported | Not reported |
|---|
Sharp-Genant total score, W104, n = 186,279
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 2.82 | 6.398 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | 1.16 | 3.429 | Not reported | Not reported | Not reported |
|---|
Erosion score, W24, n = 201, 298
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -1.6 | 12.15 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -0.4 | 10.45 | Not reported | Not reported | Not reported |
|---|
Erosion score, W56, n = 184, 273
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 1.32 | 3.155 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | 0.59 | 1.843 | Not reported | Not reported | Not reported |
|---|
Erosion score, W104, n = 186,279
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 1.81 | 4.187 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | 0.73 | 2.262 | Not reported | Not reported | Not reported |
|---|
Joint space narrowing score, W24, n = 201, 298
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -2.5 | 12.71 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -0.9 | 10.90 | Not reported | Not reported | Not reported |
|---|
Joint space narrowing score, W56, n = 184, 273
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 0.99 | 2.571 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | 0.41 | 1.323 | Not reported | Not reported | Not reported |
|---|
Joint space narrowing score, W104, n = 186,279
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 1.01 | 2.618 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | 0.43 | 1.563 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.09
- value
- -4.3
- group Id
- OG001
- spread
- 20.90
- value
- -1.2
- title
- Sharp-Genant total score, W24, n = 201, 298
- categories
- measurements
- group Id
- OG000
- spread
- 5.283
- value
- 2.31
- group Id
- OG001
- spread
- 2.751
- value
- 1.00
- title
- Sharp-Genant total score, W56, n = 184, 273
- categories
- measurements
- group Id
- OG000
- spread
- 6.398
- value
- 2.82
- group Id
- OG001
- spread
- 3.429
- value
- 1.16
- title
- Sharp-Genant total score, W104, n = 186,279
- categories
- measurements
- group Id
- OG000
- spread
- 12.15
- value
- -1.6
- group Id
- OG001
- spread
- 10.45
- value
- -0.4
- title
- Erosion score, W24, n = 201, 298
- categories
- measurements
- group Id
- OG000
- spread
- 3.155
- value
- 1.32
- group Id
- OG001
- spread
- 1.843
- value
- 0.59
- title
- Erosion score, W56, n = 184, 273
- categories
- measurements
- group Id
- OG000
- spread
- 4.187
- value
- 1.81
- group Id
- OG001
- spread
- 2.262
- value
- 0.73
- title
- Erosion score, W104, n = 186,279
- categories
- measurements
- group Id
- OG000
- spread
- 12.71
- value
- -2.5
- group Id
- OG001
- spread
- 10.90
- value
- -0.9
- title
- Joint space narrowing score, W24, n = 201, 298
- categories
- measurements
- group Id
- OG000
- spread
- 2.571
- value
- 0.99
- group Id
- OG001
- spread
- 1.323
- value
- 0.41
- title
- Joint space narrowing score, W56, n = 184, 273
- categories
- measurements
- group Id
- OG000
- spread
- 2.618
- value
- 1.01
- group Id
- OG001
- spread
- 1.563
- value
- 0.43
- title
- Joint space narrowing score, W104, n = 186,279
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 298
- 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. For all the three radiograph assessment, the minimum score is 0. A higher score indicates more damage and a negative change score indicates improvement. The change in score is to be calculated as: Change from Baseline = difference between the score at Weeks 24, 56, or 104 and the score at Baseline.
- dispersion Type
- Standard Deviation
- groups
- description
- Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
- id
- OG000
- title
- Placebo Plus Methotrexate
- description
- Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
- id
- OG001
- title
- Rituximab Plus Methotrexate
- param Type
- MEAN
- population Description
- The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) to Weeks (W) 24, 56, and 104
- title
- Mean Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score, Genant-modified Sharp Total Score, and Erosion Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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