NCT00720798 · OUTCOME
Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30
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 Week 264
What was measured
The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.
Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Groups in this outcome
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
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 |
|---|
| Tocilizumab | 2067 |
|---|
Reported measurements
Baseline (n = 2037)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 1.46 | 0.660 | Not reported | Not reported | Not reported |
|---|
Week 24 (n = 2008)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 1.04 | 0.692 | Not reported | Not reported | Not reported |
|---|
Week 48 (n = 1853)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 0.97 | 0.693 | Not reported | Not reported | Not reported |
|---|
Week 108 (n = 1635)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 0.89 | 0.694 | Not reported | Not reported | Not reported |
|---|
Week 156 (n = 1529)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 0.87 | 0.689 | Not reported | Not reported | Not reported |
|---|
Week 204 (n = 1438)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 0.84 | 0.684 | Not reported | Not reported | Not reported |
|---|
Week 264 (n = 1334)
Values in Units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 0.86 | 0.696 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.660
- value
- 1.46
- title
- Baseline (n = 2037)
- categories
- measurements
- group Id
- OG000
- spread
- 0.692
- value
- 1.04
- title
- Week 24 (n = 2008)
- categories
- measurements
- group Id
- OG000
- spread
- 0.693
- value
- 0.97
- title
- Week 48 (n = 1853)
- categories
- measurements
- group Id
- OG000
- spread
- 0.694
- value
- 0.89
- title
- Week 108 (n = 1635)
- categories
- measurements
- group Id
- OG000
- spread
- 0.689
- value
- 0.87
- title
- Week 156 (n = 1529)
- categories
- measurements
- group Id
- OG000
- spread
- 0.684
- value
- 0.84
- title
- Week 204 (n = 1438)
- categories
- measurements
- group Id
- OG000
- spread
- 0.696
- value
- 0.86
- title
- Week 264 (n = 1334)
- description
- The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
- id
- OG000
- title
- Tocilizumab
- param Type
- MEAN
- population Description
- All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
- time Frame
- Baseline to Week 264
- title
- Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
- type
- SECONDARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice
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