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NCT01721057 · OUTCOME

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

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, Week 24

What was measured

ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.

Analysis population: 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 NRI.

Groups in this outcome

Placebo

Placebo administered orally once daily through Week 24. Participants will continue to take background conventional 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
Placebo228
Baricitinib 2 mg229
Baricitinib 4 mg227

Reported measurements

Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo12.7Not reportedNot reportedNot reportedNot reported
Baricitinib 2 mg33.6Not reportedNot reportedNot reportedNot reported
Baricitinib 4 mg33.5Not reportedNot reportedNot reportedNot reported
Week 24
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo21.5Not reportedNot reportedNot reportedNot reported
Baricitinib 2 mg41.5Not reportedNot reportedNot reportedNot reported
Baricitinib 4 mg44.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12.7
      2. group Id
        OG001
        value
        33.6
      3. group Id
        OG002
        value
        33.5
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21.5
      2. group Id
        OG001
        value
        41.5
      3. group Id
        OG002
        value
        44.1
    title
    Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      229
    3. group Id
      OG002
      value
      227
    units
    Participants
description
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and 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 once daily through Week 24. Participants will continue to take background conventional 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
NUMBER
population Description
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 NRI.
reporting Status
POSTED
time Frame
Week 12, Week 24
title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice