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NCT01721057 · OUTCOME

Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily 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
MEDIAN
Unit
minutes
Interval / dispersion
95% Confidence Interval
Time frame
Week 12

What was measured

Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS 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 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
Placebo221
Baricitinib 2 mg223
Baricitinib 4 mg222

Reported measurements

Source class 1
Values in minutes · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo60.0Not reported50.776.7Not reported
Baricitinib 2 mg44.4Not reported30.060.0Not reported
Baricitinib 4 mg34.6Not reported23.751.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.7
        upper Limit
        76.7
        value
        60.0
      2. group Id
        OG001
        lower Limit
        30.0
        upper Limit
        60.0
        value
        44.4
      3. group Id
        OG002
        lower Limit
        23.7
        upper Limit
        51.4
        value
        34.6
denoms
  1. counts
    1. group Id
      OG000
      value
      221
    2. group Id
      OG001
      value
      223
    3. group Id
      OG002
      value
      222
    units
    Participants
description
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.
dispersion Type
95% Confidence Interval
groups
  1. description
    Placebo administered orally once daily through Week 24. Participants continued 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
MEDIAN
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 Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
type
SECONDARY
unit Of Measure
minutes

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

Preserved source evidence · Not medical advice