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NCT01185353 · OUTCOME

Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24

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
Not reported
Time frame
Baseline through Weeks 12 and 24

What was measured

EULAR28 categorizes clinical response based upon improvement since baseline in DAS modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: TJC28, SJC28, CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score \>5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by \>0.6 units but ≤1.2 units or post-baseline DAS28 score \>3.2 with improvement by \>1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by \>1.2 units).

Analysis population: All randomized participants who received study drug in Parts A and B and had EULAR28 evaluated at analysis time points.

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 LY300910452
8 mg LY300910450
Placebo98

Reported measurements

Good Response - Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910422Not reportedNot reportedNot reportedNot reported
2 mg LY300910417Not reportedNot reportedNot reportedNot reported
4 mg LY300910446Not reportedNot reportedNot reportedNot reported
8 mg LY300910440Not reportedNot reportedNot reportedNot reported
Placebo16Not reportedNot reportedNot reportedNot reported
Moderate Response - Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910443Not reportedNot reportedNot reportedNot reported
2 mg LY300910463Not reportedNot reportedNot reportedNot reported
4 mg LY300910431Not reportedNot reportedNot reportedNot reported
8 mg LY300910446Not reportedNot reportedNot reportedNot reported
Placebo35Not reportedNot reportedNot reportedNot reported
No Response - Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910435Not reportedNot reportedNot reportedNot reported
2 mg LY300910419Not reportedNot reportedNot reportedNot reported
4 mg LY300910423Not reportedNot reportedNot reportedNot reported
8 mg LY300910414Not reportedNot reportedNot reportedNot reported
Placebo49Not reportedNot reportedNot reportedNot reported
Good Response - Week 24
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY3009104NANot reportedNot reportedNot reportedParticipants were not dosed with 1 mg LY3009104 after Week 12, therefore percentage was not calculated.
2 mg LY300910425Not reportedNot reportedNot reportedNot reported
4 mg LY300910442Not reportedNot reportedNot reportedNot reported
8 mg LY300910446Not reportedNot reportedNot reportedNot reported
PlaceboNANot reportedNot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore percentage was not calculated.
Moderate Response - Week 24
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY3009104NANot reportedNot reportedNot reportedParticipants were not dosed with 1 mg LY3009104 after Week 12, therefore percentage was not calculated.
2 mg LY300910452Not reportedNot reportedNot reportedNot reported
4 mg LY300910442Not reportedNot reportedNot reportedNot reported
8 mg LY300910432Not reportedNot reportedNot reportedNot reported
PlaceboNANot reportedNot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore percentage was not calculated.
No Response - Week 24
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY3009104NANot reportedNot reportedNot reportedParticipants were not dosed with 1 mg LY3009104 after Week 12, therefore percentage was not calculated.
2 mg LY300910423Not reportedNot reportedNot reportedNot reported
4 mg LY300910415Not reportedNot reportedNot reportedNot reported
8 mg LY300910422Not reportedNot reportedNot reportedNot reported
PlaceboNANot reportedNot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore percentage was 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
    0.120
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.012
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
  3. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG002
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
  4. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG003
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.120
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.012
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
  3. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG002
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
  4. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG003
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        46
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        16
    title
    Good Response - Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        63
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        46
      5. group Id
        OG004
        value
        35
    title
    Moderate Response - Week 12
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        14
      5. group Id
        OG004
        value
        49
    title
    No Response - Week 12
  4. categories
    1. measurements
      1. comment
        Participants were not dosed with 1 mg LY3009104 after Week 12, therefore percentage was not calculated.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        42
      4. group Id
        OG003
        value
        46
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        value
        NA
    title
    Good Response - Week 24
  5. categories
    1. measurements
      1. comment
        Participants were not dosed with 1 mg LY3009104 after Week 12, therefore percentage was not calculated.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        42
      4. group Id
        OG003
        value
        32
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        value
        NA
    title
    Moderate Response - Week 24
  6. categories
    1. measurements
      1. comment
        Participants were not dosed with 1 mg LY3009104 after Week 12, therefore percentage was not calculated.
        group Id
        OG000
        value
        NA
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        22
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        value
        NA
    title
    No Response - Week 24
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
EULAR28 categorizes clinical response based upon improvement since baseline in DAS modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: TJC28, SJC28, CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score \>5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by \>0.6 units but ≤1.2 units or post-baseline DAS28 score \>3.2 with improvement by \>1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by \>1.2 units).
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
NUMBER
population Description
All randomized participants who received study drug in Parts A and B and had EULAR28 evaluated at analysis time points.
reporting Status
POSTED
time Frame
Baseline through Weeks 12 and 24
title
Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice