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NCT01721044 · OUTCOME

Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Week 24

What was measured

The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.

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 NRI.

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 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
Placebo176
Baricitinib 2 mg174
Baricitinib 4 mg177

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1.1Not reportedNot reportedNot reportedNot reported
Baricitinib 2 mg4.0Not reportedNot reportedNot reportedNot reported
Baricitinib 4 mg6.8Not reportedNot 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
    0.012
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Comment
    If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
    statistical Method
    Regression, Logistic
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.104
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Comment
    If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
    statistical Method
    Regression, Logistic
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
    0.012
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Comment
    If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
    statistical Method
    Regression, Logistic
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.104
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Comment
    If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.1
      2. group Id
        OG001
        value
        4.0
      3. group Id
        OG002
        value
        6.8
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    2. group Id
      OG001
      value
      174
    3. group Id
      OG002
      value
      177
    units
    Participants
description
The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
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 continued to take background cDMARD therapy throughout study.
    id
    OG002
    title
    Baricitinib 4 mg
param Type
NUMBER
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 NRI.
reporting Status
POSTED
time Frame
Week 24
title
Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice