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NCT01185353 · OUTCOME

Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness

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
minutes
Interval / dispersion
Standard Deviation
Time frame
Baseline, Weeks 4, 8, 12

What was measured

The Investigator asked participants about the duration of their morning stiffness (in minutes) in and around the joints and recorded the duration. The Investigator asked the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.

Analysis population: All randomized participants who received study drug in Part A and had morning stiffness evaluated at analysis time points. LOCF was used to impute missing post-baseline values for Week 12 analysis.

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 12 weeks in Part A. MTX was administered orally as background therapy.

4 mg LY3009104

4 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.

8 mg LY3009104

8 mg LY3009104 administered orally QD for 12 weeks in Part A. 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 LY300910448
2 mg LY300910451
4 mg LY300910450
8 mg LY300910450
Placebo97

Reported measurements

Week 4 (n=47, 50, 50, 50, 94)
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-34.170.49Not reportedNot reportedNot reported
2 mg LY3009104-27.046.49Not reportedNot reportedNot reported
4 mg LY3009104-57.4149.00Not reportedNot reportedNot reported
8 mg LY3009104-25.5126.13Not reportedNot reportedNot reported
Placebo-22.563.61Not reportedNot reportedNot reported
Week 8 (n=46, 50, 50, 50, 86)
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-41.285.45Not reportedNot reportedNot reported
2 mg LY3009104-31.145.80Not reportedNot reportedNot reported
4 mg LY3009104-67.8138.02Not reportedNot reportedNot reported
8 mg LY3009104-53.8101.76Not reportedNot reportedNot reported
Placebo-25.567.39Not reportedNot reportedNot reported
Week 12 (n=48, 51, 50, 50, 97)
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY3009104-49.572.80Not reportedNot reportedNot reported
2 mg LY3009104-30.747.41Not reportedNot reportedNot reported
4 mg LY3009104-75.0142.04Not reportedNot reportedNot reported
8 mg LY3009104-62.788.27Not reportedNot reportedNot reported
Placebo-33.991.79Not reportedNot reportedNot reported

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
    0.015
    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
    0.073
    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
    <0.001
    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
    <0.001
    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
    0.015
    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
    0.073
    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
    <0.001
    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
    <0.001
    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
        70.49
        value
        -34.1
      2. group Id
        OG001
        spread
        46.49
        value
        -27.0
      3. group Id
        OG002
        spread
        149.00
        value
        -57.4
      4. group Id
        OG003
        spread
        126.13
        value
        -25.5
      5. group Id
        OG004
        spread
        63.61
        value
        -22.5
    title
    Week 4 (n=47, 50, 50, 50, 94)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        85.45
        value
        -41.2
      2. group Id
        OG001
        spread
        45.80
        value
        -31.1
      3. group Id
        OG002
        spread
        138.02
        value
        -67.8
      4. group Id
        OG003
        spread
        101.76
        value
        -53.8
      5. group Id
        OG004
        spread
        67.39
        value
        -25.5
    title
    Week 8 (n=46, 50, 50, 50, 86)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        72.80
        value
        -49.5
      2. group Id
        OG001
        spread
        47.41
        value
        -30.7
      3. group Id
        OG002
        spread
        142.04
        value
        -75.0
      4. group Id
        OG003
        spread
        88.27
        value
        -62.7
      5. group Id
        OG004
        spread
        91.79
        value
        -33.9
    title
    Week 12 (n=48, 51, 50, 50, 97)
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    2. group Id
      OG001
      value
      51
    3. group Id
      OG002
      value
      50
    4. group Id
      OG003
      value
      50
    5. group Id
      OG004
      value
      97
    units
    Participants
description
The Investigator asked participants about the duration of their morning stiffness (in minutes) in and around the joints and recorded the duration. The Investigator asked the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.
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 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG001
    title
    2 mg LY3009104
  3. description
    4 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
    id
    OG002
    title
    4 mg LY3009104
  4. description
    8 mg LY3009104 administered orally QD for 12 weeks in Part A. 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 Part A and had morning stiffness evaluated at analysis time points. LOCF was used to impute missing post-baseline values for Week 12 analysis.
reporting Status
POSTED
time Frame
Baseline, Weeks 4, 8, 12
title
Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness
type
SECONDARY
unit Of Measure
minutes

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Preserved source evidence · Not medical advice