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NCT01185353 · OUTCOME

Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)

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
MEAN
Unit
mg/L
Interval / dispersion
Standard Deviation
Time frame
Baseline, Weeks 12 and 24

What was measured

hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.

Analysis population: All randomized participants who received study drug in Parts A and B and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.

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 24 weeks in Parts A and B. MTX was administered orally as background therapy.

4 mg LY3009104

4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.

8 mg LY3009104

8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. 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 LY300910451
8 mg LY300910450
Placebo97

Reported measurements

Week 12
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-6.1410.236Not reportedNot reportedNot reported
2 mg LY3009104-3.3919.409Not reportedNot reportedNot reported
4 mg LY3009104-7.0616.945Not reportedNot reportedNot reported
8 mg LY3009104-2.3232.582Not reportedNot reportedNot reported
Placebo1.5034.107Not reportedNot reportedNot reported
Week 24
Values in mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104NANANot reportedNot reportedParticipants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and SD were not calculated.
2 mg LY3009104-4.7618.695Not reportedNot reportedNot reported
4 mg LY3009104-4.9519.819Not reportedNot reportedNot reported
8 mg LY3009104-7.6117.548Not reportedNot reportedNot reported
PlaceboNANANot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore mean and SD were not calculated.

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. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.016
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.108
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG002
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.008
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG003
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.368
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.016
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.108
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG002
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.008
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG003
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.368
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.236
        value
        -6.14
      2. group Id
        OG001
        spread
        19.409
        value
        -3.39
      3. group Id
        OG002
        spread
        16.945
        value
        -7.06
      4. group Id
        OG003
        spread
        32.582
        value
        -2.32
      5. group Id
        OG004
        spread
        34.107
        value
        1.50
    title
    Week 12
  2. categories
    1. measurements
      1. comment
        Participants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and SD were not calculated.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. group Id
        OG001
        spread
        18.695
        value
        -4.76
      3. group Id
        OG002
        spread
        19.819
        value
        -4.95
      4. group Id
        OG003
        spread
        17.548
        value
        -7.61
      5. comment
        Participants were not dosed with placebo after Week 12, therefore mean and SD were not calculated.
        group Id
        OG004
        spread
        NA
        value
        NA
    title
    Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      52
    3. group Id
      OG002
      value
      51
    4. group Id
      OG003
      value
      50
    5. group Id
      OG004
      value
      97
    units
    Participants
description
hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
dispersion Type
Standard Deviation
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 24 weeks in Parts A and B. MTX was administered orally as background therapy.
    id
    OG001
    title
    2 mg LY3009104
  3. description
    4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
    id
    OG002
    title
    4 mg LY3009104
  4. description
    8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. 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
MEAN
population Description
All randomized participants who received study drug in Parts A and B and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.
reporting Status
POSTED
time Frame
Baseline, Weeks 12 and 24
title
Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)
type
SECONDARY
unit Of Measure
mg/L

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Preserved source evidence · Not medical advice