NCT01721057 · OUTCOME

Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

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: Week 12

What was measured

Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.

Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

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	221
Baricitinib 2 mg	223
Baricitinib 4 mg	222

Reported measurements

Source class 1

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	4.5	2.2	Not reported	Not reported	Not reported
Baricitinib 2 mg	4.0	2.5	Not reported	Not reported	Not reported
Baricitinib 4 mg	4.0	2.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.2
value
4.5
group Id
OG001
spread
2.5
value
4.0
group Id
OG002
spread
2.3
value
4.0

denoms

counts
group Id
OG000
value
221
group Id
OG001
value
223
group Id
OG002
value
222
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 and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

reporting Status

POSTED

time Frame

Week 12

title

Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice