Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
mm
Interval / dispersion
Standard Deviation
Time frame
Baseline to Week 264
What was measured
Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated "no pain" (score = 0) and the right end of the scale indicated "unbearable pain" (score = 100).
Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Groups in this outcome
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
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
Tocilizumab
2067
Reported measurements
Participant Disease Activity - Baseline (n=2039)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
60.5
25.52
Not reported
Not reported
Not reported
Participant Disease Activity - Week 24 (n=1989)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
34.4
26.03
Not reported
Not reported
Not reported
Participant Disease Activity - Week 48 (n=1840)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
31.7
25.25
Not reported
Not reported
Not reported
Participant Disease Activity - Week 108 (n=1621)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
29.2
24.75
Not reported
Not reported
Not reported
Participant Disease Activity - Week 156 (n=1515)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
28.5
25.16
Not reported
Not reported
Not reported
Participant Disease Activity - Week 204 (n=1427)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
27.4
24.72
Not reported
Not reported
Not reported
Participant Disease Activity - Week 264 (n=1328)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
27.4
25.50
Not reported
Not reported
Not reported
Physician Disease Activity - Baseline (n=2043)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
57.3
22.04
Not reported
Not reported
Not reported
Physician Disease Activity - Week 24 (n=1990)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
26.8
20.22
Not reported
Not reported
Not reported
Physician Disease Activity - Week 48 (n=1830)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
22.3
18.93
Not reported
Not reported
Not reported
Physician Disease Activity - Week 108 (n=1619)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
18.6
17.59
Not reported
Not reported
Not reported
Physician Disease Activity - Week 156 (n=1516)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
17.4
17.21
Not reported
Not reported
Not reported
Physician Disease Activity - Week 204 (n=1413)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
15.6
16.49
Not reported
Not reported
Not reported
Physician Disease Activity - Week 264 (n=1330)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
15.1
16.51
Not reported
Not reported
Not reported
Participant Pain - Baseline (n=2041)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
54.9
25.00
Not reported
Not reported
Not reported
Participant Pain - Week 24 (n=1991)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
31.0
24.56
Not reported
Not reported
Not reported
Participant Pain - Week 48 (n=1842)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
28.0
23.76
Not reported
Not reported
Not reported
Participant Pain - Week 108 (n=1622)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
26.6
23.52
Not reported
Not reported
Not reported
Participant Pain - Week 156 (n=1517)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
26.2
23.90
Not reported
Not reported
Not reported
Participant Pain - Week 204 (n=1428)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
25.3
23.05
Not reported
Not reported
Not reported
Participant Pain - Week 264 (n=1329)
Values in mm · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
25.1
23.72
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
25.52
value
60.5
title
Participant Disease Activity - Baseline (n=2039)
categories
measurements
group Id
OG000
spread
26.03
value
34.4
title
Participant Disease Activity - Week 24 (n=1989)
categories
measurements
group Id
OG000
spread
25.25
value
31.7
title
Participant Disease Activity - Week 48 (n=1840)
categories
measurements
group Id
OG000
spread
24.75
value
29.2
title
Participant Disease Activity - Week 108 (n=1621)
categories
measurements
group Id
OG000
spread
25.16
value
28.5
title
Participant Disease Activity - Week 156 (n=1515)
categories
measurements
group Id
OG000
spread
24.72
value
27.4
title
Participant Disease Activity - Week 204 (n=1427)
categories
measurements
group Id
OG000
spread
25.50
value
27.4
title
Participant Disease Activity - Week 264 (n=1328)
categories
measurements
group Id
OG000
spread
22.04
value
57.3
title
Physician Disease Activity - Baseline (n=2043)
categories
measurements
group Id
OG000
spread
20.22
value
26.8
title
Physician Disease Activity - Week 24 (n=1990)
categories
measurements
group Id
OG000
spread
18.93
value
22.3
title
Physician Disease Activity - Week 48 (n=1830)
categories
measurements
group Id
OG000
spread
17.59
value
18.6
title
Physician Disease Activity - Week 108 (n=1619)
categories
measurements
group Id
OG000
spread
17.21
value
17.4
title
Physician Disease Activity - Week 156 (n=1516)
denoms
counts
group Id
OG000
value
2067
units
Participants
description
Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated "no pain" (score = 0) and the right end of the scale indicated "unbearable pain" (score = 100).
dispersion Type
Standard Deviation
groups
description
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
id
OG000
title
Tocilizumab
param Type
MEAN
population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
time Frame
Baseline to Week 264
title
Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Triangle