NCT01721057 · BASELINE

Baseline characteristics

A Study in Moderate to Severe Rheumatoid Arthritis Participants · Source last updated 2019-09-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants

groups

description
Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG000
title
Placebo
description
Baricitinib 2 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG001
title
Baricitinib 2 mg
description
Baricitinib 4 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG002
title
Baricitinib 4 mg
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
12.5
value
51.4
group Id
BG001
spread
12.3
value
52.2
group Id
BG002
spread
12.1
value
51.8
group Id
BG003
spread
12.3
value
51.8
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
189
group Id
BG001
value
184
group Id
BG002
value
187
group Id
BG003
value
560
title
Female
measurements
group Id
BG000
value
39
group Id
BG001
value
45
group Id
BG002
value
40
group Id
BG003
value
124
title
Male
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
15
group Id
BG002
value
17
group Id
BG003
value
44
title
Hispanic or Latino
measurements
group Id
BG000
value
45
group Id
BG001
value
43
group Id
BG002
value
43
group Id
BG003
value
131
title
Not Hispanic or Latino
measurements
group Id
BG000
value
171
group Id
BG001
value
171
group Id
BG002
value
167
group Id
BG003
value
509
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
9
group Id
BG003
value
14
title
American Indian or Alaska Native
measurements
group Id
BG000
value
60
group Id
BG001
value
61
group Id
BG002
value
59
group Id
BG003
value
180
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
9
group Id
BG003
value
28
title
Black or African American
measurements
group Id
BG000
value
153
group Id
BG001
value
156
group Id
BG002
value
148
group Id
BG003
value
457
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
21
group Id
BG002
value
18
group Id
BG003
value
64
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Argentina
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
1
group Id
BG002
value
6
group Id
BG003
value
15
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
6
group Id
BG003
value
11
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
8
group Id
BG003
value
28
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
4
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Croatia
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
3
group Id
BG003
value
15
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
3
group Id
BG003
value
9
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
5
group Id
BG003
value
20
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Hungary
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
19
group Id
BG002
value
20
group Id
BG003
value
58
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
India
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
4
group Id
BG003
value
10
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
6
group Id
BG002
value
7
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
4
group Id
BG003
value
17
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Korea, Republic of
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.5
value
7.2
group Id
BG001
spread
7.6
value
7.6
group Id
BG002
spread
7.9
value
7.7
group Id
BG003
spread
7.6
value
7.5
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
225
group Id
BG002
value
225
group Id
BG003
value
678
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug and had evaluable baseline data.
title
Duration of Rheumatoid Arthritis
unit Of Measure
years
classes
categories
measurements
group Id
BG000
spread
15.0
value
24.3
group Id
BG001
spread
14.1
value
23.5
group Id
BG002
spread
14.0
value
24.3
group Id
BG003
spread
14.3
value
24.0
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Tender Joint Count of 68 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
7.2
value
13.1
group Id
BG001
spread
8.7
value
13.6
group Id
BG002
spread
6.9
value
13.5
group Id
BG003
spread
7.6
value
13.4
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Swollen Joint Count of 66 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
20.4
value
17.7
group Id
BG001
spread
21.5
value
18.2
group Id
BG002
spread
14.5
value
14.2
group Id
BG003
spread
19.1
value
16.7
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
High Sensitivity C-Reactive Protein (hsCRP)
unit Of Measure
milligram per Liter (mg/L)

population Description

Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.

Complete source fields

denoms

counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants

groups

description
Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG000
title
Placebo
description
Baricitinib 2 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG001
title
Baricitinib 2 mg
description
Baricitinib 4 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG002
title
Baricitinib 4 mg
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
12.5
value
51.4
group Id
BG001
spread
12.3
value
52.2
group Id
BG002
spread
12.1
value
51.8
group Id
BG003
spread
12.3
value
51.8
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
189
group Id
BG001
value
184
group Id
BG002
value
187
group Id
BG003
value
560
title
Female
measurements
group Id
BG000
value
39
group Id
BG001
value
45
group Id
BG002
value
40
group Id
BG003
value
124
title
Male
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
15
group Id
BG002
value
17
group Id
BG003
value
44
title
Hispanic or Latino
measurements
group Id
BG000
value
45
group Id
BG001
value
43
group Id
BG002
value
43
group Id
BG003
value
131
title
Not Hispanic or Latino
measurements
group Id
BG000
value
171
group Id
BG001
value
171
group Id
BG002
value
167
group Id
BG003
value
509
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
9
group Id
BG003
value
14
title
American Indian or Alaska Native
measurements
group Id
BG000
value
60
group Id
BG001
value
61
group Id
BG002
value
59
group Id
BG003
value
180
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
9
group Id
BG003
value
28
title
Black or African American
measurements
group Id
BG000
value
153
group Id
BG001
value
156
group Id
BG002
value
148
group Id
BG003
value
457
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
21
group Id
BG002
value
18
group Id
BG003
value
64
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Argentina
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
1
group Id
BG002
value
6
group Id
BG003
value
15
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
6
group Id
BG003
value
11
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
8
group Id
BG003
value
28
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
group Id
BG003
value
4
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Croatia
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
3
group Id
BG003
value
15
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
3
group Id
BG003
value
9
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
5
group Id
BG003
value
20
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Hungary
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
19
group Id
BG002
value
20
group Id
BG003
value
58
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
India
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
4
group Id
BG003
value
10
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
6
group Id
BG002
value
7
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
7
group Id
BG002
value
4
group Id
BG003
value
17
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
title
Korea, Republic of
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.5
value
7.2
group Id
BG001
spread
7.6
value
7.6
group Id
BG002
spread
7.9
value
7.7
group Id
BG003
spread
7.6
value
7.5
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
225
group Id
BG002
value
225
group Id
BG003
value
678
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug and had evaluable baseline data.
title
Duration of Rheumatoid Arthritis
unit Of Measure
years
classes
categories
measurements
group Id
BG000
spread
15.0
value
24.3
group Id
BG001
spread
14.1
value
23.5
group Id
BG002
spread
14.0
value
24.3
group Id
BG003
spread
14.3
value
24.0
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Tender Joint Count of 68 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
7.2
value
13.1
group Id
BG001
spread
8.7
value
13.6
group Id
BG002
spread
6.9
value
13.5
group Id
BG003
spread
7.6
value
13.4
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Swollen Joint Count of 66 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
20.4
value
17.7
group Id
BG001
spread
21.5
value
18.2
group Id
BG002
spread
14.5
value
14.2
group Id
BG003
spread
19.1
value
16.7
denoms
counts
group Id
BG000
value
228
group Id
BG001
value
229
group Id
BG002
value
227
group Id
BG003
value
684
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
High Sensitivity C-Reactive Protein (hsCRP)
unit Of Measure
milligram per Liter (mg/L)

population Description

Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.

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Preserved source evidence · Not medical advice