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NCT01185353 · OUTCOME

Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response

A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2017-06-16

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
95% Confidence Interval
Time frame
Baseline through Week 12

What was measured

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.

Analysis population: All randomized participants who received study drug in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by LOCF.

Groups in this outcome

1 mg LY3009104

1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

2 mg LY3009104

2 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

4 mg LY3009104

4 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

8 mg LY3009104

8 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

Placebo

Placebo administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
1 mg LY300910449
2 mg LY300910452
4 mg LY300910452
8 mg LY300910450
Placebo98

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
1 mg LY300910454.6Not reported42.267.1Not reported
2 mg LY300910455.2Not reported42.367.6Not reported
4 mg LY300910474.3Not reported63.184.1Not reported
8 mg LY300910477.2Not reported65.986.7Not reported
Placebo42.1Not reported32.951.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.2
        upper Limit
        67.1
        value
        54.6
      2. group Id
        OG001
        lower Limit
        42.3
        upper Limit
        67.6
        value
        55.2
      3. group Id
        OG002
        lower Limit
        63.1
        upper Limit
        84.1
        value
        74.3
      4. group Id
        OG003
        lower Limit
        65.9
        upper Limit
        86.7
        value
        77.2
      5. group Id
        OG004
        lower Limit
        32.9
        upper Limit
        51.6
        value
        42.1
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      52
    3. group Id
      OG002
      value
      52
    4. group Id
      OG003
      value
      50
    5. group Id
      OG004
      value
      98
    units
    Participants
description
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.
dispersion Type
95% Confidence Interval
groups
  1. description
    1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG000
    title
    1 mg LY3009104
  2. description
    2 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG001
    title
    2 mg LY3009104
  3. description
    4 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG002
    title
    4 mg LY3009104
  4. description
    8 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG003
    title
    8 mg LY3009104
  5. description
    Placebo administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG004
    title
    Placebo
param Type
NUMBER
population Description
All randomized participants who received study drug in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by LOCF.
reporting Status
POSTED
time Frame
Baseline through Week 12
title
Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice