NCT01721044 · OUTCOME

Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg

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: MEAN
Unit: Units on a Scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 12

What was measured

DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

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 mBOCF.

Groups in this outcome

Placebo

Placebo 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	174
Baricitinib 4 mg	177

Reported measurements

Source class 1

Values in Units on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.85	1.19	Not reported	Not reported	Not reported
Baricitinib 4 mg	-1.81	1.43	Not reported	Not reported	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.001
statistical Method
ANCOVA

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.001
statistical Method
ANCOVA

classes

categories
measurements
group Id
OG000
spread
1.19
value
-0.85
group Id
OG001
spread
1.43
value
-1.81

denoms

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

description

dispersion Type

Standard Deviation

groups

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

param Type

MEAN

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 mBOCF.

reporting Status

POSTED

time Frame

Baseline, Week 12

title

Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg

type

SECONDARY

unit Of Measure

Units on a Scale

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

Preserved source evidence · Not medical advice