TriangleNCT02097745 · OUTCOME
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to the end of the retreatment period (up to 7 years, 6 months)
What was measured
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 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 \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 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 | 67.5 | Not reported | Not reported | Not reported | Not reported |
Retreatment 2 (n = 267)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 74.9 | Not reported | Not reported | Not reported | Not reported |
Retreatment 3 (n = 234)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 73.9 | Not reported | Not reported | Not reported | Not reported |
Retreatment 4 (n = 175)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 67.4 | Not reported | Not reported | Not reported | Not reported |
Retreatment 5 (n = 136)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 69.9 | Not reported | Not reported | Not reported | Not reported |
Retreatment 6 (n = 92)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 72.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 67.5
- title
- Retreatment 1 (n = 320)
- categories
- measurements
- group Id
- OG000
- value
- 74.9
- title
- Retreatment 2 (n = 267)
- categories
- measurements
- group Id
- OG000
- value
- 73.9
- title
- Retreatment 3 (n = 234)
- categories
- measurements
- group Id
- OG000
- value
- 67.4
- title
- Retreatment 4 (n = 175)
- categories
- measurements
- group Id
- OG000
- value
- 69.9
- title
- Retreatment 5 (n = 136)
- categories
- measurements
- group Id
- OG000
- value
- 72.8
- title
- Retreatment 6 (n = 92)
- denoms
- counts
- group Id
- OG000
- value
- 335
- units
- Participants
- description
- A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 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 \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
- 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
- NUMBER
- 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
- Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice