NCT02093026 · OUTCOME
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) · Source last updated 2017-03-13
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
- 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)
What was measured
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Analysis population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
Groups in this outcome
Rituximab
Participants received rituximab 1 gram 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. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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 | 447 |
|---|
Reported measurements
24 weeks after first course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 447 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.51 | 0.555 | Not reported | Not reported | Not reported |
|---|
24 weeks after second course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 386 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.48 | 0.556 | Not reported | Not reported | Not reported |
|---|
24 weeks after third course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 309 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.43 | 0.532 | Not reported | Not reported | Not reported |
|---|
24 weeks after fourth course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 245 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.47 | 0.529 | Not reported | Not reported | Not reported |
|---|
24 weeks after fifth course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 174 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.44 | 0.541 | Not reported | Not reported | Not reported |
|---|
24 weeks after sixth course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 106 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.38 | 0.600 | Not reported | Not reported | Not reported |
|---|
24 weeks after seventh course
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 68 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | -0.37 | 0.576 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.555
- value
- -0.51
- title
- 24 weeks after first course
- categories
- measurements
- group Id
- OG000
- spread
- 0.556
- value
- -0.48
- title
- 24 weeks after second course
- categories
- measurements
- group Id
- OG000
- spread
- 0.532
- value
- -0.43
- title
- 24 weeks after third course
- categories
- measurements
- group Id
- OG000
- spread
- 0.529
- value
- -0.47
- title
- 24 weeks after fourth course
- categories
- measurements
- group Id
- OG000
- spread
- 0.541
- value
- -0.44
- title
- 24 weeks after fifth course
- categories
- measurements
- group Id
- OG000
- spread
- 0.600
- value
- -0.38
- title
- 24 weeks after sixth course
- categories
- measurements
- group Id
- OG000
- spread
- 0.576
- value
- -0.37
- title
- 24 weeks after seventh course
- description
- The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received rituximab 1 gram 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. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
- id
- OG000
- title
- Rituximab
- param Type
- MEAN
- population Description
- ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
- reporting Status
- POSTED
- time Frame
- 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)
- title
- Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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