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NCT01721044 · OUTCOME

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores

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, Week 24

What was measured

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.

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 mLOCF.

Groups in this outcome

Placebo

Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg 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

GroupSource count
Placebo170
Baricitinib 2 mg170
Baricitinib 4 mg174

Reported measurements

Week 12
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo5.910.5Not reportedNot reportedNot reported
Baricitinib 2 mg8.810.0Not reportedNot reportedNot reported
Baricitinib 4 mg8.59.9Not reportedNot reportedNot reported
Week 24
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo6.610.7Not reportedNot reportedNot reported
Baricitinib 2 mg8.810.4Not reportedNot reportedNot reported
Baricitinib 4 mg9.710.7Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Description
    Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.005
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Description
    Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.004
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Description
    Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.002
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Description
    Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.026
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.005
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Description
    Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.004
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Description
    Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.002
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Description
    Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.026
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.5
        value
        5.9
      2. group Id
        OG001
        spread
        10.0
        value
        8.8
      3. group Id
        OG002
        spread
        9.9
        value
        8.5
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.7
        value
        6.6
      2. group Id
        OG001
        spread
        10.4
        value
        8.8
      3. group Id
        OG002
        spread
        10.7
        value
        9.7
    title
    Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      170
    2. group Id
      OG001
      value
      170
    3. group Id
      OG002
      value
      174
    units
    Participants
description
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
dispersion Type
Standard Deviation
groups
  1. description
    Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    OG000
    title
    Placebo
  2. description
    Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    OG001
    title
    Baricitinib 2 mg
  3. description
    Baricitinib 4 mg administered PO QD 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 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 mLOCF.
reporting Status
POSTED
time Frame
Baseline, Week 12, Week 24
title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
type
SECONDARY
unit Of Measure
Units on a Scale

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

Preserved source evidence · Not medical advice