NCT01721044 · BASELINE

Baseline characteristics

A Moderate to Severe Rheumatoid Arthritis Study · 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
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants

groups

description
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG000
title
Placebo
description
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG001
title
Baricitinib 2 mg
description
Baricitinib 4 mg administered 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
10.7
value
56.0
group Id
BG001
spread
11.1
value
55.1
group Id
BG002
spread
11.3
value
55.9
group Id
BG003
spread
11.0
value
55.7
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
145
group Id
BG001
value
137
group Id
BG002
value
149
group Id
BG003
value
431
title
Female
measurements
group Id
BG000
value
31
group Id
BG001
value
37
group Id
BG002
value
28
group Id
BG003
value
96
title
Male
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
12
group Id
BG002
value
11
group Id
BG003
value
32
title
American Indian or Alaska Native
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
12
group Id
BG003
value
32
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
7
group Id
BG003
value
24
title
Black or African American
measurements
group Id
BG000
value
147
group Id
BG001
value
144
group Id
BG002
value
144
group Id
BG003
value
435
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
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
9
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Argentina
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
4
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
group Id
BG003
value
16
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
3
group Id
BG003
value
8
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
1
group Id
BG003
value
6
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
10
group Id
BG002
value
7
group Id
BG003
value
24
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
France
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
19
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
2
group Id
BG003
value
9
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
8
group Id
BG002
value
13
group Id
BG003
value
30
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Israel
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
8
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
8
group Id
BG003
value
20
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Japan
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
9.6
value
14.0
group Id
BG001
spread
8.0
value
13.7
group Id
BG002
spread
9.4
value
14.3
group Id
BG003
spread
9.0
value
14.0
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
description
Time from Symptom Onset of Rheumatoid Arthritis
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Duration of Rheumatoid Arthritis
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
spread
16.4
value
28.3
group Id
BG001
spread
16.3
value
31.0
group Id
BG002
spread
15.6
value
28.1
group Id
BG003
spread
16.1
value
29.1
denoms
counts
group Id
BG000
value
174
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
525
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Tender joint count based on 68 joints.
title
Tender Joint Count of 68 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
10.8
value
17.2
group Id
BG001
spread
12.3
value
18.6
group Id
BG002
spread
8.9
value
16.3
group Id
BG003
spread
10.8
value
17.4
denoms
counts
group Id
BG000
value
174
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
525
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Swollen joint count based on 66 joints.
title
Swollen Joint Count of 66 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
25.26
value
20.64
group Id
BG001
spread
22.48
value
19.87
group Id
BG002
spread
24.84
value
19.76
group Id
BG003
spread
24.19
value
20.09
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
High Sensitivity C-Reactive Protein (hsCRP)
unit Of Measure
milligrams/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
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants

groups

description
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG000
title
Placebo
description
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
BG001
title
Baricitinib 2 mg
description
Baricitinib 4 mg administered 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
10.7
value
56.0
group Id
BG001
spread
11.1
value
55.1
group Id
BG002
spread
11.3
value
55.9
group Id
BG003
spread
11.0
value
55.7
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
145
group Id
BG001
value
137
group Id
BG002
value
149
group Id
BG003
value
431
title
Female
measurements
group Id
BG000
value
31
group Id
BG001
value
37
group Id
BG002
value
28
group Id
BG003
value
96
title
Male
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
12
group Id
BG002
value
11
group Id
BG003
value
32
title
American Indian or Alaska Native
measurements
group Id
BG000
value
11
group Id
BG001
value
9
group Id
BG002
value
12
group Id
BG003
value
32
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
7
group Id
BG003
value
24
title
Black or African American
measurements
group Id
BG000
value
147
group Id
BG001
value
144
group Id
BG002
value
144
group Id
BG003
value
435
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
3
group Id
BG003
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
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
9
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Argentina
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
9
group Id
BG002
value
4
group Id
BG003
value
21
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
3
group Id
BG002
value
8
group Id
BG003
value
16
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
3
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
3
group Id
BG003
value
8
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
1
group Id
BG003
value
6
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
10
group Id
BG002
value
7
group Id
BG003
value
24
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
France
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
19
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
2
group Id
BG003
value
9
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
8
group Id
BG002
value
13
group Id
BG003
value
30
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Israel
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
3
group Id
BG003
value
8
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
8
group Id
BG003
value
20
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
title
Japan
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
9.6
value
14.0
group Id
BG001
spread
8.0
value
13.7
group Id
BG002
spread
9.4
value
14.3
group Id
BG003
spread
9.0
value
14.0
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
description
Time from Symptom Onset of Rheumatoid Arthritis
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Duration of Rheumatoid Arthritis
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
spread
16.4
value
28.3
group Id
BG001
spread
16.3
value
31.0
group Id
BG002
spread
15.6
value
28.1
group Id
BG003
spread
16.1
value
29.1
denoms
counts
group Id
BG000
value
174
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
525
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Tender joint count based on 68 joints.
title
Tender Joint Count of 68 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
10.8
value
17.2
group Id
BG001
spread
12.3
value
18.6
group Id
BG002
spread
8.9
value
16.3
group Id
BG003
spread
10.8
value
17.4
denoms
counts
group Id
BG000
value
174
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
525
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Swollen joint count based on 66 joints.
title
Swollen Joint Count of 66 Evaluable Joints
unit Of Measure
Number of Joints
classes
categories
measurements
group Id
BG000
spread
25.26
value
20.64
group Id
BG001
spread
22.48
value
19.87
group Id
BG002
spread
24.84
value
19.76
group Id
BG003
spread
24.19
value
20.09
denoms
counts
group Id
BG000
value
176
group Id
BG001
value
174
group Id
BG002
value
177
group Id
BG003
value
527
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
High Sensitivity C-Reactive Protein (hsCRP)
unit Of Measure
milligrams/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.

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

Preserved source evidence · Not medical advice