Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01721057 · OUTCOME

Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Week 12

What was measured

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Analysis population: Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).

Groups in this outcome

Placebo

Placebo administered orally (PO) once daily (QD)through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg 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
Placebo228
Baricitinib 2 mg229
Baricitinib 4 mg227

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo39.5Not reportedNot reportedNot reportedNot reported
Baricitinib 2 mg65.9Not reportedNot reportedNot reportedNot reported
Baricitinib 4 mg61.7Not 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
    0.001
    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
    0.001
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        39.5
      2. group Id
        OG001
        value
        65.9
      3. group Id
        OG002
        value
        61.7
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      229
    3. group Id
      OG002
      value
      227
    units
    Participants
description
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
groups
  1. description
    Placebo administered orally (PO) once daily (QD)through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
    id
    OG000
    title
    Placebo
  2. description
    Baricitinib 2 mg 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 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
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).
reporting Status
POSTED
time Frame
Week 12
title
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice