NCT01721057 · OUTCOME

Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)

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.

Measure: MEAN
Unit: units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 12

What was measured

DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.

Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.

Groups in this outcome

Placebo

Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg administered orally once daily 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	220
Baricitinib 2 mg	226
Baricitinib 4 mg	221

Reported measurements

Source class 1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-1.16	1.27	Not reported	Not reported	Not reported
Baricitinib 2 mg	-1.89	1.23	Not reported	Not reported	Not reported
Baricitinib 4 mg	-1.97	1.16	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.27
value
-1.16
group Id
OG001
spread
1.23
value
-1.89
group Id
OG002
spread
1.16
value
-1.97

denoms

counts
group Id
OG000
value
220
group Id
OG001
value
226
group Id
OG002
value
221
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
id
OG000
title
Placebo
description
Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
OG001
title
Baricitinib 2 mg
description
Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
id
OG002
title
Baricitinib 4 mg

param Type

MEAN

population Description

mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.

reporting Status

POSTED

time Frame

Baseline, Week 12

title

Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice