NCT00422383 · OUTCOME

Short-Form 36 Health Survey (SF-36) Score

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, Week (Wk) 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) = 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	128
Rituximab Escalated Dose Methotrexate	116
Rituximab High Dose + Methotrexate	91

Reported measurements

Bodily Pain Score: BL (n=128,115,90)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	31.657	7.5764	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	30.815	6.5633	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	30.319	6.2328	Not reported	Not reported	Not reported

Bodily Pain Score: Wk 24 (n=118,108,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	39.709	9.2218	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	38.875	8.3432	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	42.736	9.7885	Not reported	Not reported	Not reported

Bodily Pain Score: Wk 48 (n=119,103,89)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	41.318	9.2879	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	40.836	8.6176	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	43.105	9.4713	Not reported	Not reported	Not reported

General Health Score: BL (n=127,116,90)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	34.850	9.5814	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	34.692	9.3289	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	34.025	8.8533	Not reported	Not reported	Not reported

General Health Score: Wk 24 (n=116,109,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	39.644	9.8338	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	39.805	10.2346	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	39.050	10.4236	Not reported	Not reported	Not reported

General Health Score: Wk 48 (n=118,101,89)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	41.138	10.3191	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	41.555	9.9892	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	40.427	10.5756	Not reported	Not reported	Not reported

Mental Health Score: BL (n=128,116,90)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	38.443	12.4207	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	38.307	11.9908	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	38.405	11.1899	Not reported	Not reported	Not reported

Mental Health Score: Wk 24 (n=118,108,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	43.506	11.5661	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	43.209	10.7315	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	43.955	10.6107	Not reported	Not reported	Not reported

Mental Health Score: Wk 48 (n=119,102,88)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	44.529	11.7796	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	44.447	11.9128	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	43.640	11.5868	Not reported	Not reported	Not reported

Physical Functioning Score: BL (n=127,116,91)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	28.826	9.5523	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	28.223	9.8730	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	29.896	8.7899	Not reported	Not reported	Not reported

Physical Functioning Score: Wk 24 (n=116,109,86)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	34.286	11.1702	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	33.929	11.3543	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	37.323	10.5428	Not reported	Not reported	Not reported

Physical Functioning Score: Wk 48 (n=118,103,89)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	35.291	11.7203	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	35.318	10.6680	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	38.547	11.6649	Not reported	Not reported	Not reported

Emotional Role Score: BL (n=127,115,90)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	33.719	13.9238	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	32.217	11.9819	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	32.167	13.6914	Not reported	Not reported	Not reported

Emotional Role Score: Wk 24 (n=117,109,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	39.665	13.1752	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	37.406	13.2790	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	39.928	13.4008	Not reported	Not reported	Not reported

Emotional Role Score: Wk 48 (n=118,102,88)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	40.429	13.7266	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	39.644	12.7514	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	39.800	14.0611	Not reported	Not reported	Not reported

Physical Role Score: BL (n=127,116,90)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	31.013	9.5785	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	30.864	8.7546	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	32.309	9.4529	Not reported	Not reported	Not reported

Physical Role Score: Wk 24 (n=117,109,86)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	37.694	9.8439	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	36.977	9.6325	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	39.027	10.9050	Not reported	Not reported	Not reported

Physical Role Score: Wk 48 (n=119,102,89)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	38.599	10.9559	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	39.086	9.6230	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	40.362	10.1419	Not reported	Not reported	Not reported

Social Functioning Score: BL (n=128,116,91)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	34.948	11.6147	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	33.341	11.3817	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	35.812	12.2109	Not reported	Not reported	Not reported

Social Functioning Score: Wk 24 (n=118,109,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	40.765	10.5247	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	40.737	10.4537	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	42.869	10.8028	Not reported	Not reported	Not reported

Social Functioning Score: Wk 48 (n=119,103,89)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	42.366	11.1916	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	42.235	11.0464	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	43.613	11.3599	Not reported	Not reported	Not reported

Vitality Score: BL (n=128,116,91)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	38.253	10.2709	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	38.096	9.5184	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	39.832	10.2209	Not reported	Not reported	Not reported

Vitality Score: Wk 24 (n=118,109,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	45.000	10.7039	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	44.577	11.1008	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	46.206	10.0519	Not reported	Not reported	Not reported

Vitality Score: Wk 48 (n=119,103,87)

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Rituximab Low Dose + Methotrexate	46.905	10.5538	Not reported	Not reported	Not reported
Rituximab Escalated Dose Methotrexate	46.251	10.8299	Not reported	Not reported	Not reported
Rituximab High Dose + Methotrexate	47.462	11.3098	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
7.5764
value
31.657
group Id
OG001
spread
6.5633
value
30.815
group Id
OG002
spread
6.2328
value
30.319
title
Bodily Pain Score: BL (n=128,115,90)
categories
measurements
group Id
OG000
spread
9.2218
value
39.709
group Id
OG001
spread
8.3432
value
38.875
group Id
OG002
spread
9.7885
value
42.736
title
Bodily Pain Score: Wk 24 (n=118,108,87)
categories
measurements
group Id
OG000
spread
9.2879
value
41.318
group Id
OG001
spread
8.6176
value
40.836
group Id
OG002
spread
9.4713
value
43.105
title
Bodily Pain Score: Wk 48 (n=119,103,89)
categories
measurements
group Id
OG000
spread
9.5814
value
34.850
group Id
OG001
spread
9.3289
value
34.692
group Id
OG002
spread
8.8533
value
34.025
title
General Health Score: BL (n=127,116,90)
categories
measurements
group Id
OG000
spread
9.8338
value
39.644
group Id
OG001
spread
10.2346
value
39.805
group Id
OG002
spread
10.4236
value
39.050
title
General Health Score: Wk 24 (n=116,109,87)
categories
measurements
group Id
OG000
spread
10.3191
value
41.138
group Id
OG001
spread
9.9892
value
41.555
group Id
OG002
spread
10.5756
value
40.427
title
General Health Score: Wk 48 (n=118,101,89)
categories
measurements
group Id
OG000
spread
12.4207
value
38.443
group Id
OG001
spread
11.9908
value
38.307
group Id
OG002
spread
11.1899
value
38.405
title
Mental Health Score: BL (n=128,116,90)
categories
measurements
group Id
OG000
spread
11.5661
value
43.506
group Id
OG001
spread
10.7315
value
43.209
group Id
OG002
spread
10.6107
value
43.955
title
Mental Health Score: Wk 24 (n=118,108,87)
categories
measurements
group Id
OG000
spread
11.7796
value
44.529
group Id
OG001
spread
11.9128
value
44.447
group Id
OG002
spread
11.5868
value
43.640
title
Mental Health Score: Wk 48 (n=119,102,88)
categories
measurements
group Id
OG000
spread
9.5523
value
28.826
group Id
OG001
spread
9.8730
value
28.223
group Id
OG002
spread
8.7899
value
29.896
title
Physical Functioning Score: BL (n=127,116,91)
categories
measurements
group Id
OG000
spread
11.1702
value
34.286
group Id
OG001
spread
11.3543
value
33.929
group Id
OG002
spread
10.5428
value
37.323
title
Physical Functioning Score: Wk 24 (n=116,109,86)
categories
measurements
group Id
OG000
spread
11.7203
value
35.291
group Id
OG001
spread
10.6680
value
35.318
group Id
OG002
spread
11.6649
value
38.547
title
Physical Functioning Score: Wk 48 (n=118,103,89)

denoms

counts
group Id
OG000
value
128
group Id
OG001
value
116
group Id
OG002
value
91
units
Participants

description

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) = number of participants analyzed for the given parameter at the specified timepoint.

reporting Status

POSTED

time Frame

BL, Week (Wk) 24 and 48

title

Short-Form 36 Health Survey (SF-36) Score

type

SECONDARY

unit Of Measure

score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice