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NCT01721057 · OUTCOME

Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores

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; Baseline Week 24

What was measured

European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.

Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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

GroupSource count
Placebo216
Baricitinib 2 mg227
Baricitinib 4 mg216

Reported measurements

Index Score (US Algorithm) Week 12
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0540.155Not reportedNot reportedNot reported
Baricitinib 2 mg0.1170.151Not reportedNot reportedNot reported
Baricitinib 4 mg0.1090.165Not reportedNot reportedNot reported
Index Score (US Algorithm) Week 24
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0510.149Not reportedNot reportedNot reported
Baricitinib 2 mg0.1130.172Not reportedNot reportedNot reported
Baricitinib 4 mg0.1290.173Not reportedNot reportedNot reported
Index Score (UK Algorithm) Week 12
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0740.230Not reportedNot reportedNot reported
Baricitinib 2 mg0.1670.221Not reportedNot reportedNot reported
Baricitinib 4 mg0.1590.237Not reportedNot reportedNot reported
Index Score (UK Algorithm) Week 24
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0750.218Not reportedNot reportedNot reported
Baricitinib 2 mg0.1620.254Not reportedNot reportedNot reported
Baricitinib 4 mg0.1850.250Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.155
        value
        0.054
      2. group Id
        OG001
        spread
        0.151
        value
        0.117
      3. group Id
        OG002
        spread
        0.165
        value
        0.109
    title
    Index Score (US Algorithm) Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.149
        value
        0.051
      2. group Id
        OG001
        spread
        0.172
        value
        0.113
      3. group Id
        OG002
        spread
        0.173
        value
        0.129
    title
    Index Score (US Algorithm) Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.230
        value
        0.074
      2. group Id
        OG001
        spread
        0.221
        value
        0.167
      3. group Id
        OG002
        spread
        0.237
        value
        0.159
    title
    Index Score (UK Algorithm) Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.218
        value
        0.075
      2. group Id
        OG001
        spread
        0.254
        value
        0.162
      3. group Id
        OG002
        spread
        0.250
        value
        0.185
    title
    Index Score (UK Algorithm) Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      216
    2. group Id
      OG001
      value
      227
    3. group Id
      OG002
      value
      216
    units
    Participants
description
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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
  3. 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 , with a baseline value and at least 1 post-baseline value. 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; Baseline Week 24
title
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice