TriangleNCT02097745 · OUTCOME
Change From Baseline in the American College of Rheumatology n (ACRn) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percentage change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline to the end of the retreatment period (up to 7 years, 6 months)
What was measured
The ACRn response was defined as each participant's least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
Analysis population: Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.
Groups in this outcome
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 |
|---|---|
| Rituximab | 335 |
Reported measurements
Retreatment 1 (n = 320)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 32.04 | 37.709 | Not reported | Not reported | Not reported |
Retreatment 2 (n = 267)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 39.25 | 35.494 | Not reported | Not reported | Not reported |
Retreatment 3 (n = 234)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 39.89 | 41.166 | Not reported | Not reported | Not reported |
Retreatment 4 (n = 175)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 37.71 | 43.201 | Not reported | Not reported | Not reported |
Retreatment 5 (n = 136)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 37.59 | 41.109 | Not reported | Not reported | Not reported |
Retreatment 6 (n = 92)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 35.53 | 38.650 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 37.709
- value
- 32.04
- title
- Retreatment 1 (n = 320)
- categories
- measurements
- group Id
- OG000
- spread
- 35.494
- value
- 39.25
- title
- Retreatment 2 (n = 267)
- categories
- measurements
- group Id
- OG000
- spread
- 41.166
- value
- 39.89
- title
- Retreatment 3 (n = 234)
- categories
- measurements
- group Id
- OG000
- spread
- 43.201
- value
- 37.71
- title
- Retreatment 4 (n = 175)
- categories
- measurements
- group Id
- OG000
- spread
- 41.109
- value
- 37.59
- title
- Retreatment 5 (n = 136)
- categories
- measurements
- group Id
- OG000
- spread
- 38.650
- value
- 35.53
- title
- Retreatment 6 (n = 92)
- denoms
- counts
- group Id
- OG000
- value
- 335
- units
- Participants
- description
- The ACRn response was defined as each participant's least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
- dispersion Type
- Standard Deviation
- groups
- 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
- OG000
- 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.
- reporting Status
- POSTED
- time Frame
- Baseline to the end of the retreatment period (up to 7 years, 6 months)
- title
- Change From Baseline in the American College of Rheumatology n (ACRn) Response
- type
- SECONDARY
- unit Of Measure
- Percentage change
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Preserved source evidence · Not medical advice