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NCT01185353 · OUTCOME

Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain

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
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Weeks 12 and 24

What was measured

Physician's and Patient's Assessments of Disease Activity (DA) assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeters (mm), where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis was also assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).

Analysis population: All randomized participants who received study drug in Parts A and B and had physician's and participant's assessments of disease activity and participant's pain 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
Placebo98

Reported measurements

Physician's Assessment of DA - Week 12
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-23.918.49Not reportedNot reportedNot reported
2 mg LY3009104-25.020.81Not reportedNot reportedNot reported
4 mg LY3009104-30.418.75Not reportedNot reportedNot reported
8 mg LY3009104-33.519.49Not reportedNot reportedNot reported
Placebo-19.021.40Not reportedNot reportedNot reported
Physician's Assessment of DA - Week 24
Values in units on a scale · 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 LY3009104-27.821.13Not reportedNot reportedNot reported
4 mg LY3009104-35.517.72Not reportedNot reportedNot reported
8 mg LY3009104-37.818.73Not reportedNot reportedNot reported
PlaceboNANANot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore mean and SD were not calculated.
Patient's Assessment of DA - Week 12
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-24.927.26Not reportedNot reportedNot reported
2 mg LY3009104-16.222.43Not reportedNot reportedNot reported
4 mg LY3009104-25.421.61Not reportedNot reportedNot reported
8 mg LY3009104-29.821.20Not reportedNot reportedNot reported
Placebo-10.322.02Not reportedNot reportedNot reported
Patient's Assessment of DA - Week 24
Values in units on a scale · 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 LY3009104-16.924.96Not reportedNot reportedNot reported
4 mg LY3009104-30.221.85Not reportedNot reportedNot reported
8 mg LY3009104-30.020.90Not reportedNot reportedNot reported
PlaceboNANANot reportedNot reportedParticipants were not dosed with placebo after Week 12, therefore mean and SD were not calculated.
Patient's Assessment of Pain - Week 12
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-22.827.39Not reportedNot reportedNot reported
2 mg LY3009104-14.217.82Not reportedNot reportedNot reported
4 mg LY3009104-25.019.22Not reportedNot reportedNot reported
8 mg LY3009104-25.320.31Not reportedNot reportedNot reported
Placebo-8.822.77Not reportedNot reportedNot reported
Patient's Assessment of Pain - Week 24
Values in units on a scale · 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 LY3009104-14.720.57Not reportedNot reportedNot reported
4 mg LY3009104-27.322.11Not reportedNot reportedNot reported
8 mg LY3009104-26.919.22Not 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
    0.217
    p Value Comment
    P-value is for Physician's Assessment of DA - 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
    0.092
    p Value Comment
    P-value is for Physician's Assessment of DA - 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
    <0.001
    p Value Comment
    P-value is for Physician's Assessment of DA - 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
    <0.001
    p Value Comment
    P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  5. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  6. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.072
    p Value Comment
    P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  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 Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  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 Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  9. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  10. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.082
    p Value Comment
    P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  11. 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 Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  12. 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 Patient's Assessment of Pain - 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
    0.217
    p Value Comment
    P-value is for Physician's Assessment of DA - 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
    0.092
    p Value Comment
    P-value is for Physician's Assessment of DA - 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
    <0.001
    p Value Comment
    P-value is for Physician's Assessment of DA - 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
    <0.001
    p Value Comment
    P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  5. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  6. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.072
    p Value Comment
    P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  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 Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  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 Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  9. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  10. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG001
    2. OG004
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.082
    p Value Comment
    P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  11. 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 Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
  12. 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 Patient's Assessment of Pain - 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
        18.49
        value
        -23.9
      2. group Id
        OG001
        spread
        20.81
        value
        -25.0
      3. group Id
        OG002
        spread
        18.75
        value
        -30.4
      4. group Id
        OG003
        spread
        19.49
        value
        -33.5
      5. group Id
        OG004
        spread
        21.40
        value
        -19.0
    title
    Physician's Assessment of DA - 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
        21.13
        value
        -27.8
      3. group Id
        OG002
        spread
        17.72
        value
        -35.5
      4. group Id
        OG003
        spread
        18.73
        value
        -37.8
      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
    Physician's Assessment of DA - Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.26
        value
        -24.9
      2. group Id
        OG001
        spread
        22.43
        value
        -16.2
      3. group Id
        OG002
        spread
        21.61
        value
        -25.4
      4. group Id
        OG003
        spread
        21.20
        value
        -29.8
      5. group Id
        OG004
        spread
        22.02
        value
        -10.3
    title
    Patient's Assessment of DA - Week 12
  4. 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
        24.96
        value
        -16.9
      3. group Id
        OG002
        spread
        21.85
        value
        -30.2
      4. group Id
        OG003
        spread
        20.90
        value
        -30.0
      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
    Patient's Assessment of DA - Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.39
        value
        -22.8
      2. group Id
        OG001
        spread
        17.82
        value
        -14.2
      3. group Id
        OG002
        spread
        19.22
        value
        -25.0
      4. group Id
        OG003
        spread
        20.31
        value
        -25.3
      5. group Id
        OG004
        spread
        22.77
        value
        -8.8
    title
    Patient's Assessment of Pain - Week 12
  6. 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
        20.57
        value
        -14.7
      3. group Id
        OG002
        spread
        22.11
        value
        -27.3
      4. group Id
        OG003
        spread
        19.22
        value
        -26.9
      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
    Patient's Assessment of Pain - 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
      98
    units
    Participants
description
Physician's and Patient's Assessments of Disease Activity (DA) assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeters (mm), where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis was also assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).
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 physician's and participant's assessments of disease activity and participant's pain 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 Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
type
SECONDARY
unit Of Measure
units on a scale

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