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NCT01185353 · OUTCOME

ACR Percent Improvement (ACR-N)

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 improvement
Interval / dispersion
95% Confidence Interval
Time frame
Baseline through Week 12

What was measured

ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of a) % of improvement in TJC, b) % of improvement in SJC, and c) third highest percentage of improvement of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to a range of -100 to 100 to minimize impact of outliers (greater scores indicate greater % improvement) and negative scores indicate a decline. 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 ACR-N 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 improvement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
1 mg LY300910417.30Not reported7.5728.22Not reported
2 mg LY300910419.42Not reported8.7429.25Not reported
4 mg LY300910428.59Not reported17.6740.83Not reported
8 mg LY300910429.00Not reported17.6741.47Not reported
Placebo10.97Not reported-0.3921.64Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.57
        upper Limit
        28.22
        value
        17.30
      2. group Id
        OG001
        lower Limit
        8.74
        upper Limit
        29.25
        value
        19.42
      3. group Id
        OG002
        lower Limit
        17.67
        upper Limit
        40.83
        value
        28.59
      4. group Id
        OG003
        lower Limit
        17.67
        upper Limit
        41.47
        value
        29.00
      5. group Id
        OG004
        lower Limit
        -0.39
        upper Limit
        21.64
        value
        10.97
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
ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of a) % of improvement in TJC, b) % of improvement in SJC, and c) third highest percentage of improvement of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to a range of -100 to 100 to minimize impact of outliers (greater scores indicate greater % improvement) and negative scores indicate a decline. 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 ACR-N at Week 12 had these components imputed by LOCF.
reporting Status
POSTED
time Frame
Baseline through Week 12
title
ACR Percent Improvement (ACR-N)
type
SECONDARY
unit Of Measure
percentage of improvement

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Preserved source evidence · Not medical advice