A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
BL, Weeks 24 and 48
What was measured
SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.
Analysis population: ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.
Groups in this outcome
Rituximab Low Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab Escalated Dose Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab High Dose + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
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 Low Dose + Methotrexate
116
Rituximab Escalated Dose Methotrexate
108
Rituximab High Dose + Methotrexate
88
Reported measurements
Bodily Pain Score: Wk 24 (n=115,106,85)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
8.180
9.7621
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
7.914
8.7302
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
11.948
10.2846
Not reported
Not reported
Not reported
Bodily Pain Score: Wk 48 (n=116,101,87)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
9.815
9.4616
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
9.323
9.3335
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
12.712
10.3962
Not reported
Not reported
Not reported
General Health Score: Wk 24 (n=112,108,85)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
4.941
8.8122
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
4.996
8.7345
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
4.812
8.1955
Not reported
Not reported
Not reported
General Health Score: Wk 48 (n=115,100,87)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
6.470
8.9736
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
6.340
8.9124
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
6.241
8.4496
Not reported
Not reported
Not reported
Mental Health Score: Wk 24 (n=115,107,85)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
5.173
10.5160
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
4.138
11.5165
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
5.312
8.1965
Not reported
Not reported
Not reported
Mental Health Score: Wk 48 (n=116,101,86)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
6.607
10.6356
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
4.979
12.3225
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
4.939
11.0695
Not reported
Not reported
Not reported
Physical Functioning Score: Wk 24 (n=111,108,85)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
5.517
7.6418
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
6.261
8.2243
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
7.081
9.4105
Not reported
Not reported
Not reported
Physical Functioning Score: Wk 48 (n=114,102,88)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
6.529
8.6382
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
6.318
9.8785
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
8.577
10.9439
Not reported
Not reported
Not reported
Emotional Role Score: Wk 24 (n=113,108,85)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
5.951
11.9256
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
4.571
12.5182
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
7.180
12.0934
Not reported
Not reported
Not reported
Emotional Role Score: Wk 48 (n=114,101,86)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
6.445
14.0187
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
6.350
12.4357
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
7.142
13.4771
Not reported
Not reported
Not reported
Physical Role Score: Wk 24 (n=113,108,84)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
6.473
9.1079
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
5.994
9.7472
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
6.385
9.6101
Not reported
Not reported
Not reported
Physical Role Score: Wk 48 (n=115,101,87)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
7.347
10.0663
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
7.493
9.8317
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
7.873
9.6133
Not reported
Not reported
Not reported
Social Functioning Score: Wk 24 (n=115,108,86
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
5.786
9.8861
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
7.070
11.1663
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
6.722
9.8518
Not reported
Not reported
Not reported
Social Functioning Score: Wk 48 (n=116,102,88)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
7.382
10.9376
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
7.807
11.1880
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
7.713
11.3046
Not reported
Not reported
Not reported
Vitality Score: Wk 24 (n=115,108,86)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
6.796
10.7057
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
6.495
10.2488
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
6.534
8.8644
Not reported
Not reported
Not reported
Vitality Score: Wk 48 (n=116,102,86)
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Rituximab Low Dose + Methotrexate
9.088
10.6821
Not reported
Not reported
Not reported
Rituximab Escalated Dose Methotrexate
7.479
10.2350
Not reported
Not reported
Not reported
Rituximab High Dose + Methotrexate
7.200
10.3652
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
9.7621
value
8.180
group Id
OG001
spread
8.7302
value
7.914
group Id
OG002
spread
10.2846
value
11.948
title
Bodily Pain Score: Wk 24 (n=115,106,85)
categories
measurements
group Id
OG000
spread
9.4616
value
9.815
group Id
OG001
spread
9.3335
value
9.323
group Id
OG002
spread
10.3962
value
12.712
title
Bodily Pain Score: Wk 48 (n=116,101,87)
categories
measurements
group Id
OG000
spread
8.8122
value
4.941
group Id
OG001
spread
8.7345
value
4.996
group Id
OG002
spread
8.1955
value
4.812
title
General Health Score: Wk 24 (n=112,108,85)
categories
measurements
group Id
OG000
spread
8.9736
value
6.470
group Id
OG001
spread
8.9124
value
6.340
group Id
OG002
spread
8.4496
value
6.241
title
General Health Score: Wk 48 (n=115,100,87)
categories
measurements
group Id
OG000
spread
10.5160
value
5.173
group Id
OG001
spread
11.5165
value
4.138
group Id
OG002
spread
8.1965
value
5.312
title
Mental Health Score: Wk 24 (n=115,107,85)
categories
measurements
group Id
OG000
spread
10.6356
value
6.607
group Id
OG001
spread
12.3225
value
4.979
group Id
OG002
spread
11.0695
value
4.939
title
Mental Health Score: Wk 48 (n=116,101,86)
categories
measurements
group Id
OG000
spread
7.6418
value
5.517
group Id
OG001
spread
8.2243
value
6.261
group Id
OG002
spread
9.4105
value
7.081
title
Physical Functioning Score: Wk 24 (n=111,108,85)
categories
measurements
group Id
OG000
spread
8.6382
value
6.529
group Id
OG001
spread
9.8785
value
6.318
group Id
OG002
spread
10.9439
value
8.577
title
Physical Functioning Score: Wk 48 (n=114,102,88)
categories
measurements
group Id
OG000
spread
11.9256
value
5.951
group Id
OG001
spread
12.5182
value
4.571
group Id
OG002
spread
12.0934
value
7.180
title
Emotional Role Score: Wk 24 (n=113,108,85)
categories
measurements
group Id
OG000
spread
14.0187
value
6.445
group Id
OG001
spread
12.4357
value
6.350
group Id
OG002
spread
13.4771
value
7.142
title
Emotional Role Score: Wk 48 (n=114,101,86)
categories
measurements
group Id
OG000
spread
9.1079
value
6.473
group Id
OG001
spread
9.7472
value
5.994
group Id
OG002
spread
9.6101
value
6.385
title
Physical Role Score: Wk 24 (n=113,108,84)
categories
measurements
group Id
OG000
spread
10.0663
value
7.347
group Id
OG001
spread
9.8317
value
7.493
group Id
OG002
spread
9.6133
value
7.873
title
Physical Role Score: Wk 48 (n=115,101,87)
denoms
counts
group Id
OG000
value
116
group Id
OG001
value
108
group Id
OG002
value
88
units
Participants
description
SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.
dispersion Type
Standard Deviation
groups
description
Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
id
OG000
title
Rituximab Low Dose + Methotrexate
description
Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
id
OG001
title
Rituximab Escalated Dose Methotrexate
description
Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
id
OG002
title
Rituximab High Dose + Methotrexate
param Type
MEAN
population Description
ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.
Triangle