NCT01721044 · OUTCOME

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

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.

Measure: NUMBER
Unit: Percentage of Participants
Interval / dispersion: Not reported
Time frame: Week 12 and Week 24

What was measured

ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.

Analysis population: mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.

Groups in this outcome

Placebo

Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

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
Placebo	176
Baricitinib 2 mg	174
Baricitinib 4 mg	177

Reported measurements

Week 12

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	8.0	Not reported	Not reported	Not reported	Not reported
Baricitinib 2 mg	20.1	Not reported	Not reported	Not reported	Not reported
Baricitinib 4 mg	28.2	Not reported	Not reported	Not reported	Not reported

Week 24

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	13.1	Not reported	Not reported	Not reported	Not reported
Baricitinib 2 mg	23.0	Not reported	Not reported	Not reported	Not reported
Baricitinib 4 mg	29.4	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
group Description
Week 12
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.001
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic
ci Num Sides
TWO_SIDED
group Description
Week 12
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.002
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic
ci Num Sides
TWO_SIDED
group Description
Week 24
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.001
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic
ci Num Sides
TWO_SIDED
group Description
Week 24
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.015
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Description
Week 12
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.001
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic
ci Num Sides
TWO_SIDED
group Description
Week 12
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.002
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic
ci Num Sides
TWO_SIDED
group Description
Week 24
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.001
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic
ci Num Sides
TWO_SIDED
group Description
Week 24
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.015
p Value Comment
a priori p-value significance threshold: 2-sided ≤0.05
statistical Comment
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
8.0
group Id
OG001
value
20.1
group Id
OG002
value
28.2
title
Week 12
categories
measurements
group Id
OG000
value
13.1
group Id
OG001
value
23.0
group Id
OG002
value
29.4
title
Week 24

denoms

counts
group Id
OG000
value
176
group Id
OG001
value
174
group Id
OG002
value
177
units
Participants

description

groups

description
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
OG000
title
Placebo
description
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
OG001
title
Baricitinib 2 mg
description
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
OG002
title
Baricitinib 4 mg

param Type

NUMBER

population Description

mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.

reporting Status

POSTED

time Frame

Week 12 and Week 24

title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice