NCT00266227 · OUTCOME

Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2013-10-25

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: Baseline, Week 48

What was measured

The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.

Analysis population: Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.

Groups in this outcome

Arm A: Rituximab Re-treatment

1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.

Arm B: Placebo Re-treatment

1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.

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
Arm A: Rituximab Re-treatment	312
Arm B: Placebo Re-treatment	154

Reported measurements

Mental Health Score

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm A: Rituximab Re-treatment	4.6	11.80	Not reported	Not reported	Not reported
Arm B: Placebo Re-treatment	3.9	13.50	Not reported	Not reported	Not reported

Physical Health Score

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm A: Rituximab Re-treatment	6.4	8.76	Not reported	Not reported	Not reported
Arm B: Placebo Re-treatment	4.8	8.97	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
11.80
value
4.6
group Id
OG001
spread
13.50
value
3.9
title
Mental Health Score
categories
measurements
group Id
OG000
spread
8.76
value
6.4
group Id
OG001
spread
8.97
value
4.8
title
Physical Health Score

denoms

counts
group Id
OG000
value
312
group Id
OG001
value
154
units
Participants

description

dispersion Type

Standard Deviation

groups

description
1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
id
OG000
title
Arm A: Rituximab Re-treatment
description
1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
id
OG001
title
Arm B: Placebo Re-treatment

param Type

MEAN

population Description

Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.

reporting Status

POSTED

time Frame

Baseline, Week 48

title

Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects

type

SECONDARY

unit Of Measure

Score on a scale

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

Preserved source evidence · Not medical advice