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NCT01185353 · OUTCOME

Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 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 2, 4, 8, 12, 16, 20, 24

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 points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) \* 100.

Analysis population: All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR20 index at analysis time points 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 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

Week 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910429Not reportedNot reportedNot reportedNot reported
2 mg LY300910421Not reportedNot reportedNot reportedNot reported
4 mg LY300910442Not reportedNot reportedNot reportedNot reported
8 mg LY300910444Not reportedNot reportedNot reportedNot reported
Placebo11Not reportedNot reportedNot reportedNot reported
Week 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910443Not reportedNot reportedNot reportedNot reported
2 mg LY300910437Not reportedNot reportedNot reportedNot reported
4 mg LY300910460Not reportedNot reportedNot reportedNot reported
8 mg LY300910454Not reportedNot reportedNot reportedNot reported
Placebo24Not reportedNot reportedNot reportedNot reported
Week 8
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910443Not reportedNot reportedNot reportedNot reported
2 mg LY300910442Not reportedNot reportedNot reportedNot reported
4 mg LY300910467Not reportedNot reportedNot reportedNot reported
8 mg LY300910472Not reportedNot reportedNot reportedNot reported
Placebo36Not reportedNot reportedNot reportedNot reported
Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910457Not reportedNot reportedNot reportedNot reported
2 mg LY300910454Not reportedNot reportedNot reportedNot reported
4 mg LY300910475Not reportedNot reportedNot reportedNot reported
8 mg LY300910478Not reportedNot reportedNot reportedNot reported
Placebo41Not reportedNot reportedNot reportedNot reported
Week 16
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 LY300910463Not reportedNot reportedNot reportedNot reported
4 mg LY300910467Not reportedNot reportedNot reportedNot reported
8 mg LY300910464Not reportedNot reportedNot reportedNot reported
PlaceboNANot reportedNot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore percentage was not calculated.
Week 20
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 LY300910471Not reportedNot reportedNot reportedNot reported
4 mg LY300910477Not reportedNot reportedNot reportedNot reported
8 mg LY300910478Not reportedNot reportedNot reportedNot reported
PlaceboNANot reportedNot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore percentage was not calculated.
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 LY300910462Not reportedNot reportedNot reportedNot reported
4 mg LY300910475Not reportedNot reportedNot reportedNot reported
8 mg LY300910472Not 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
    0.045
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.088
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
  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 Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
  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 Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.045
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.088
    p Value Comment
    P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
  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 Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
  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 Week 12. A priori p-value significance threshold: 1-sided ≤0.10.
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        42
      4. group Id
        OG003
        value
        44
      5. group Id
        OG004
        value
        11
    title
    Week 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        60
      4. group Id
        OG003
        value
        54
      5. group Id
        OG004
        value
        24
    title
    Week 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        42
      3. group Id
        OG002
        value
        67
      4. group Id
        OG003
        value
        72
      5. group Id
        OG004
        value
        36
    title
    Week 8
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        54
      3. group Id
        OG002
        value
        75
      4. group Id
        OG003
        value
        78
      5. group Id
        OG004
        value
        41
    title
    Week 12
  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
        63
      3. group Id
        OG002
        value
        67
      4. group Id
        OG003
        value
        64
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        value
        NA
    title
    Week 16
  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
        71
      3. group Id
        OG002
        value
        77
      4. group Id
        OG003
        value
        78
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        value
        NA
    title
    Week 20
  7. 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
        62
      3. group Id
        OG002
        value
        75
      4. group Id
        OG003
        value
        72
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        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
      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 points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) \* 100.
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. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.
reporting Status
POSTED
time Frame
Baseline through Weeks 2, 4, 8, 12, 16, 20, 24
title
Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice