Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01185353 · OUTCOME

Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score

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 FACIT-F Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.

Analysis population: All randomized participants who received study drug in Part A and had FACIT-F evaluated at Week 12. 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

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1 mg LY30091044.4810.492Not reportedNot reportedNot reported
2 mg LY30091043.809.152Not reportedNot reportedNot reported
4 mg LY30091044.418.631Not reportedNot reportedNot reported
8 mg LY30091044.119.971Not reportedNot reportedNot reported
Placebo2.028.941Not 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
    0.203
    p Value Comment
    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
    0.164
    p Value Comment
    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
    0.018
    p Value Comment
    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
    0.097
    p Value Comment
    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
    0.203
    p Value Comment
    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
    0.164
    p Value Comment
    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
    0.018
    p Value Comment
    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
    0.097
    p Value Comment
    A priori p-value significance threshold: 2-sided ≤0.10.
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.492
        value
        4.48
      2. group Id
        OG001
        spread
        9.152
        value
        3.80
      3. group Id
        OG002
        spread
        8.631
        value
        4.41
      4. group Id
        OG003
        spread
        9.971
        value
        4.11
      5. group Id
        OG004
        spread
        8.941
        value
        2.02
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 FACIT-F Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
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 FACIT-F evaluated at Week 12. 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 Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice