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NCT01721044 · OUTCOME

Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness

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
MEDIAN
Unit
Minutes
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Week 24

What was measured

Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.

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
Placebo172
Baricitinib 2 mg172
Baricitinib 4 mg175

Reported measurements

Source class 1
Values in Minutes · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo-8.0Not reported-15.00.0Not reported
Baricitinib 2 mg-25.5Not reported-40.0-15.0Not reported
Baricitinib 4 mg-27.0Not reported-40.0-15.0Not 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 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
    Wilcoxon (Mann-Whitney)
  2. ci Num Sides
    TWO_SIDED
    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
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    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
    Wilcoxon (Mann-Whitney)
  2. ci Num Sides
    TWO_SIDED
    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
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -15.0
        upper Limit
        0.0
        value
        -8.0
      2. group Id
        OG001
        lower Limit
        -40.0
        upper Limit
        -15.0
        value
        -25.5
      3. group Id
        OG002
        lower Limit
        -40.0
        upper Limit
        -15.0
        value
        -27.0
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      172
    3. group Id
      OG002
      value
      175
    units
    Participants
description
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
dispersion Type
95% Confidence Interval
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
MEDIAN
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 24
title
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
type
SECONDARY
unit Of Measure
Minutes

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Preserved source evidence · Not medical advice