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NCT01721057 · OUTCOME

Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)

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

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.

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

Baricitinib 2 mg

Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg PO QD through week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24. Participants will continue 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
Placebo218
Baricitinib 2 mg229
Baricitinib 4 mg219

Reported measurements

Week 12, MCS
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.310.6Not reportedNot reportedNot reported
Baricitinib 2 mg3.610.5Not reportedNot reportedNot reported
Baricitinib 4 mg3.311.0Not reportedNot reportedNot reported
Week 24, MCS
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.711.5Not reportedNot reportedNot reported
Baricitinib 2 mg3.010.4Not reportedNot reportedNot reported
Baricitinib 4 mg3.311.3Not reportedNot reportedNot reported
Week 12, PCS
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo4.17.3Not reportedNot reportedNot reported
Baricitinib 2 mg7.78.5Not reportedNot reportedNot reported
Baricitinib 4 mg7.08.3Not reportedNot reportedNot reported
Week 24, PCS
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo4.98.0Not reportedNot reportedNot reported
Baricitinib 2 mg8.59.0Not reportedNot reportedNot reported
Baricitinib 4 mg8.69.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.6
        value
        3.3
      2. group Id
        OG001
        spread
        10.5
        value
        3.6
      3. group Id
        OG002
        spread
        11.0
        value
        3.3
    title
    Week 12, MCS
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.5
        value
        2.7
      2. group Id
        OG001
        spread
        10.4
        value
        3.0
      3. group Id
        OG002
        spread
        11.3
        value
        3.3
    title
    Week 24, MCS
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.3
        value
        4.1
      2. group Id
        OG001
        spread
        8.5
        value
        7.7
      3. group Id
        OG002
        spread
        8.3
        value
        7.0
    title
    Week 12, PCS
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.0
        value
        4.9
      2. group Id
        OG001
        spread
        9.0
        value
        8.5
      3. group Id
        OG002
        spread
        9.0
        value
        8.6
    title
    Week 24, PCS
denoms
  1. counts
    1. group Id
      OG000
      value
      218
    2. group Id
      OG001
      value
      229
    3. group Id
      OG002
      value
      219
    units
    Participants
description
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
dispersion Type
Standard Deviation
groups
  1. description
    Placebo administered orally (PO) once daily (QD) 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 PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
    id
    OG001
    title
    Baricitinib 2 mg
  3. description
    Baricitinib 4 mg PO QD through week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24. Participants will continue 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 Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice