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NCT01721044 · OUTCOME

Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)

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

What was measured

DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

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 modified last observation carried forward (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 will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg administered PO QD 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
Placebo168
Baricitinib 2 mg169
Baricitinib 4 mg173

Reported measurements

Source class 1
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.921.21Not reportedNot reportedNot reported
Baricitinib 2 mg-1.521.37Not reportedNot reportedNot reported
Baricitinib 4 mg-1.801.44Not 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 Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    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 Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    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
        1.21
        value
        -0.92
      2. group Id
        OG001
        spread
        1.37
        value
        -1.52
      3. group Id
        OG002
        spread
        1.44
        value
        -1.80
denoms
  1. counts
    1. group Id
      OG000
      value
      168
    2. group Id
      OG001
      value
      169
    3. group Id
      OG002
      value
      173
    units
    Participants
description
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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 will continue 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 will continue 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 modified last observation carried forward (mLOCF).
reporting Status
POSTED
time Frame
Baseline, Week 12
title
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
type
SECONDARY
unit Of Measure
Units on a Scale

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

Preserved source evidence · Not medical advice