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NCT01185353 · OUTCOME

Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

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, Week 12

What was measured

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains (physical functioning, bodily pain, role limitations due to physical problems and also emotional problems, general health, mental health, social functioning and vitality) and 2 component scores (PCS and MCS). The PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. The MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.

Analysis population: All randomized participants who received study drug in Part A and had SF-36 evaluated at analysis time point. 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 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 LY300910451
8 mg LY300910450
Placebo97

Reported measurements

PCS
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY30091046.668.074Not reportedNot reportedNot reported
2 mg LY30091044.157.680Not reportedNot reportedNot reported
4 mg LY30091047.077.378Not reportedNot reportedNot reported
8 mg LY30091047.009.054Not reportedNot reportedNot reported
Placebo3.226.733Not reportedNot reportedNot reported
MCS
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY30091042.5411.983Not reportedNot reportedNot reported
2 mg LY30091041.896.869Not reportedNot reportedNot reported
4 mg LY30091042.397.898Not reportedNot reportedNot reported
8 mg LY30091043.0310.675Not reportedNot reportedNot reported
Placebo0.8810.437Not 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
    0.021
    p Value Comment
    P-value is for PCS. 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
    0.194
    p Value Comment
    P-value is for PCS. 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 PCS. 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
    0.012
    p Value Comment
    P-value is for PCS. 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
    0.449
    p Value Comment
    P-value is for MCS. 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
    0.578
    p Value Comment
    P-value is for MCS. 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
    0.140
    p Value Comment
    P-value is for MCS. 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
    0.266
    p Value Comment
    P-value is for MCS. 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
    0.021
    p Value Comment
    P-value is for PCS. 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
    0.194
    p Value Comment
    P-value is for PCS. 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 PCS. 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
    0.012
    p Value Comment
    P-value is for PCS. 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
    0.449
    p Value Comment
    P-value is for MCS. 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
    0.578
    p Value Comment
    P-value is for MCS. 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
    0.140
    p Value Comment
    P-value is for MCS. 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
    0.266
    p Value Comment
    P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.074
        value
        6.66
      2. group Id
        OG001
        spread
        7.680
        value
        4.15
      3. group Id
        OG002
        spread
        7.378
        value
        7.07
      4. group Id
        OG003
        spread
        9.054
        value
        7.00
      5. group Id
        OG004
        spread
        6.733
        value
        3.22
    title
    PCS
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.983
        value
        2.54
      2. group Id
        OG001
        spread
        6.869
        value
        1.89
      3. group Id
        OG002
        spread
        7.898
        value
        2.39
      4. group Id
        OG003
        spread
        10.675
        value
        3.03
      5. group Id
        OG004
        spread
        10.437
        value
        0.88
    title
    MCS
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    2. group Id
      OG001
      value
      51
    3. group Id
      OG002
      value
      51
    4. group Id
      OG003
      value
      50
    5. group Id
      OG004
      value
      97
    units
    Participants
description
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains (physical functioning, bodily pain, role limitations due to physical problems and also emotional problems, general health, mental health, social functioning and vitality) and 2 component scores (PCS and MCS). The PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. The MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.
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 SF-36 evaluated at analysis time point. LOCF was used to impute missing post-baseline values.
reporting Status
POSTED
time Frame
Baseline, Week 12
title
Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice