NCT00468546 · OUTCOME
Percentage Change From Baseline in the ACR Core Set (SJC, TJC, Patient's and Physician's Global Assessments, Health Assessment Questionnaire, Pain, C-Reactive Protein, and Erythrocyte Sedimentation Rate) Score
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- From Baseline (Day 1) to Week 24
What was measured
Percentage change in the scores of the following parameters of ACR core set relative to respective baseline scores in both study arms was analyzed : SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS \[0 = no disease activity to 100 = maximum disease activity\]), HAQ (based on HAQ disability index \[HAQDI\]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain), CRP concentration, and ESR.
Analysis population: The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
Groups in this outcome
Placebo Plus Methotrexate
Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
Rituximab Plus Methotrexate
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
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 |
|---|
| Placebo Plus Methotrexate | 201 |
|---|
| Rituximab Plus Methotrexate | 298 |
|---|
Reported measurements
SJC (66)
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -5.6 | 59.19 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -43.0 | 52.65 | Not reported | Not reported | Not reported |
|---|
SJC (28)
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -7.1 | 55.35 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -41.3 | 52.77 | Not reported | Not reported | Not reported |
|---|
TJC (68)
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 7.2 | 144.58 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -41.8 | 52.39 | Not reported | Not reported | Not reported |
|---|
TJC (28)
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 15.7 | 195.94 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -42.0 | 63.47 | Not reported | Not reported | Not reported |
|---|
Physician's global assessment
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -4.2 | 47.23 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -40.8 | 39.31 | Not reported | Not reported | Not reported |
|---|
Patient's global assessment
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -3.1 | 44.01 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -25.4 | 117.90 | Not reported | Not reported | Not reported |
|---|
Patient's pain assessment
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 2.8 | 55.61 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -23.8 | 131.59 | Not reported | Not reported | Not reported |
|---|
HAQ
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | -2.0 | 30.46 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -24.3 | 34.92 | Not reported | Not reported | Not reported |
|---|
CRP
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 80.0 | 452.94 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -36.3 | 80.3 | Not reported | Not reported | Not reported |
|---|
ESR
Values in percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo Plus Methotrexate | 11.4 | 95.95 | Not reported | Not reported | Not reported |
|---|
| Rituximab Plus Methotrexate | -29.3 | 59.92 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 59.19
- value
- -5.6
- group Id
- OG001
- spread
- 52.65
- value
- -43.0
- title
- SJC (66)
- categories
- measurements
- group Id
- OG000
- spread
- 55.35
- value
- -7.1
- group Id
- OG001
- spread
- 52.77
- value
- -41.3
- title
- SJC (28)
- categories
- measurements
- group Id
- OG000
- spread
- 144.58
- value
- 7.2
- group Id
- OG001
- spread
- 52.39
- value
- -41.8
- title
- TJC (68)
- categories
- measurements
- group Id
- OG000
- spread
- 195.94
- value
- 15.7
- group Id
- OG001
- spread
- 63.47
- value
- -42.0
- title
- TJC (28)
- categories
- measurements
- group Id
- OG000
- spread
- 47.23
- value
- -4.2
- group Id
- OG001
- spread
- 39.31
- value
- -40.8
- title
- Physician's global assessment
- categories
- measurements
- group Id
- OG000
- spread
- 44.01
- value
- -3.1
- group Id
- OG001
- spread
- 117.90
- value
- -25.4
- title
- Patient's global assessment
- categories
- measurements
- group Id
- OG000
- spread
- 55.61
- value
- 2.8
- group Id
- OG001
- spread
- 131.59
- value
- -23.8
- title
- Patient's pain assessment
- categories
- measurements
- group Id
- OG000
- spread
- 30.46
- value
- -2.0
- group Id
- OG001
- spread
- 34.92
- value
- -24.3
- title
- HAQ
- categories
- measurements
- group Id
- OG000
- spread
- 452.94
- value
- 80.0
- group Id
- OG001
- spread
- 80.3
- value
- -36.3
- title
- CRP
- categories
- measurements
- group Id
- OG000
- spread
- 95.95
- value
- 11.4
- group Id
- OG001
- spread
- 59.92
- value
- -29.3
- title
- ESR
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 298
- units
- Participants
- description
- Percentage change in the scores of the following parameters of ACR core set relative to respective baseline scores in both study arms was analyzed : SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS \[0 = no disease activity to 100 = maximum disease activity\]), HAQ (based on HAQ disability index \[HAQDI\]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain), CRP concentration, and ESR.
- dispersion Type
- Standard Deviation
- groups
- description
- Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
- id
- OG000
- title
- Placebo Plus Methotrexate
- description
- Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
- id
- OG001
- title
- Rituximab Plus Methotrexate
- param Type
- MEAN
- population Description
- The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) to Week 24
- title
- Percentage Change From Baseline in the ACR Core Set (SJC, TJC, Patient's and Physician's Global Assessments, Health Assessment Questionnaire, Pain, C-Reactive Protein, and Erythrocyte Sedimentation Rate) Score
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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