NCT02097745 · OUTCOME
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies · Source last updated 2016-11-03
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 the end of the retreatment period (up to 7 years, 6 months)
What was measured
The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 335 |
|---|
Reported measurements
Retreatment 1: Physical Health (n = 249)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 7.383 | 8.4618 | Not reported | Not reported | Not reported |
|---|
Retreatment 1: Mental Health
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5.550 | 12.0705 | Not reported | Not reported | Not reported |
|---|
Retreatment 2: Physical Health (n = 255)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 6.018 | 7.9757 | Not reported | Not reported | Not reported |
|---|
Retreatment 2: Mental Health
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5.746 | 10.7778 | Not reported | Not reported | Not reported |
|---|
Retreatment 3: Physical Health (n = 220)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 6.206 | 8.2326 | Not reported | Not reported | Not reported |
|---|
Retreatment 3: Mental Health
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 4.777 | 10.1916 | Not reported | Not reported | Not reported |
|---|
Retreatment 4: Physical Health (n = 167)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5.660 | 7.9137 | Not reported | Not reported | Not reported |
|---|
Retreatment 4: Mental Health
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 4.864 | 10.2215 | Not reported | Not reported | Not reported |
|---|
Retreatment 5: Physical Health (n = 124)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5.038 | 8.2643 | Not reported | Not reported | Not reported |
|---|
Retreatment 5: Mental Health
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5.141 | 11.8848 | Not reported | Not reported | Not reported |
|---|
Retreatment 6: Physical Health (n = 88)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5.214 | 7.5370 | Not reported | Not reported | Not reported |
|---|
Retreatment 6: Mental Health
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 2.658 | 9.8556 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.4618
- value
- 7.383
- title
- Retreatment 1: Physical Health (n = 249)
- categories
- measurements
- group Id
- OG000
- spread
- 12.0705
- value
- 5.550
- title
- Retreatment 1: Mental Health
- categories
- measurements
- group Id
- OG000
- spread
- 7.9757
- value
- 6.018
- title
- Retreatment 2: Physical Health (n = 255)
- categories
- measurements
- group Id
- OG000
- spread
- 10.7778
- value
- 5.746
- title
- Retreatment 2: Mental Health
- categories
- measurements
- group Id
- OG000
- spread
- 8.2326
- value
- 6.206
- title
- Retreatment 3: Physical Health (n = 220)
- categories
- measurements
- group Id
- OG000
- spread
- 10.1916
- value
- 4.777
- title
- Retreatment 3: Mental Health
- categories
- measurements
- group Id
- OG000
- spread
- 7.9137
- value
- 5.660
- title
- Retreatment 4: Physical Health (n = 167)
- categories
- measurements
- group Id
- OG000
- spread
- 10.2215
- value
- 4.864
- title
- Retreatment 4: Mental Health
- categories
- measurements
- group Id
- OG000
- spread
- 8.2643
- value
- 5.038
- title
- Retreatment 5: Physical Health (n = 124)
- categories
- measurements
- group Id
- OG000
- spread
- 11.8848
- value
- 5.141
- title
- Retreatment 5: Mental Health
- categories
- measurements
- group Id
- OG000
- spread
- 7.5370
- value
- 5.214
- title
- Retreatment 6: Physical Health (n = 88)
- categories
- measurements
- group Id
- OG000
- spread
- 9.8556
- value
- 2.658
- title
- Retreatment 6: Mental Health
- description
- The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.
- 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 Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
- type
- SECONDARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice
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