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NCT01185353 · OUTCOME

Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) 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

Disease Activity Score (DAS) modified to include 28-joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP \[milligrams per liter (mg/L)\], and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores \<2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.

Analysis population: All randomized participants who received study drug in Parts A and B and had DAS28-CRP 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

Low Disease Activity - Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910422Not reportedNot reportedNot reportedNot reported
2 mg LY300910423Not reportedNot reportedNot reportedNot reported
4 mg LY300910448Not reportedNot reportedNot reportedNot reported
8 mg LY300910440Not reportedNot reportedNot reportedNot reported
Placebo19Not reportedNot reportedNot reportedNot reported
Remission - Week 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1 mg LY300910414Not reportedNot reportedNot reportedNot reported
2 mg LY300910415Not reportedNot reportedNot reportedNot reported
4 mg LY300910437Not reportedNot reportedNot reportedNot reported
8 mg LY300910422Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Low Disease Activity - 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 LY300910431Not reportedNot reportedNot reportedNot reported
4 mg LY300910450Not 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.
Remission - 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 LY300910415Not reportedNot reportedNot reportedNot reported
4 mg LY300910433Not reportedNot reportedNot reportedNot reported
8 mg LY300910436Not 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
    0.409
    p Value Comment
    P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-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
    0.371
    p Value Comment
    P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-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 Low Disease Activity - Week 12. A priori p-value significance threshold: 2-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
    0.007
    p Value Comment
    P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  5. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.033
    p Value Comment
    P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  6. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.019
    p Value Comment
    P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  7. 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 Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  8. 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 Remission - Week 12. A priori p-value significance threshold: 2-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
    0.409
    p Value Comment
    P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-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
    0.371
    p Value Comment
    P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-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 Low Disease Activity - Week 12. A priori p-value significance threshold: 2-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
    0.007
    p Value Comment
    P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  5. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.033
    p Value Comment
    P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  6. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.019
    p Value Comment
    P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  7. 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 Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
  8. 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 Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        48
      4. group Id
        OG003
        value
        40
      5. group Id
        OG004
        value
        19
    title
    Low Disease Activity - Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        37
      4. group Id
        OG003
        value
        22
      5. group Id
        OG004
        value
        4
    title
    Remission - Week 12
  3. 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
        31
      3. group Id
        OG002
        value
        50
      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
    Low Disease Activity - Week 24
  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
        15
      3. group Id
        OG002
        value
        33
      4. group Id
        OG003
        value
        36
      5. comment
        Participants were not dosed with placebo after Week 12, therefore percentage was not calculated.
        group Id
        OG004
        value
        NA
    title
    Remission - 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
Disease Activity Score (DAS) modified to include 28-joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP \[milligrams per liter (mg/L)\], and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores \<2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.
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 DAS28-CRP evaluated at analysis time points.
reporting Status
POSTED
time Frame
Baseline through Weeks 12 and 24
title
Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24
type
SECONDARY
unit Of Measure
percentage of participants

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