NCT01185353 · OUTCOME

Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) 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, Weeks 12 and 24

What was measured

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

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

Group	Source count
1 mg LY3009104	49
2 mg LY3009104	52
4 mg LY3009104	51
8 mg LY3009104	50
Placebo	98

Reported measurements

Week 12

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1 mg LY3009104	-0.35	0.528	Not reported	Not reported	Not reported
2 mg LY3009104	-0.18	0.524	Not reported	Not reported	Not reported
4 mg LY3009104	-0.33	0.459	Not reported	Not reported	Not reported
8 mg LY3009104	-0.39	0.497	Not reported	Not reported	Not reported
Placebo	-0.10	0.406	Not reported	Not reported	Not reported

Week 24

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1 mg LY3009104	NA	NA	Not reported	Not reported	Participants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and SD were not calculated.
2 mg LY3009104	-0.18	0.505	Not reported	Not reported	Not reported
4 mg LY3009104	-0.32	0.506	Not reported	Not reported	Not reported
8 mg LY3009104	-0.44	0.529	Not reported	Not reported	Not reported
Placebo	NA	NA	Not reported	Not reported	Participants 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.

ci Num Sides
TWO_SIDED
group Ids
OG000
OG004
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.003
p Value Comment
P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
statistical Method
ANCOVA
ci Num Sides
TWO_SIDED
group Ids
OG001
OG004
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.167
p Value Comment
P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
statistical Method
ANCOVA
ci Num Sides
TWO_SIDED
group Ids
OG002
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
ci Num Sides
TWO_SIDED
group Ids
OG003
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

ci Num Sides
TWO_SIDED
group Ids
OG000
OG004
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.003
p Value Comment
P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
statistical Method
ANCOVA
ci Num Sides
TWO_SIDED
group Ids
OG001
OG004
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.167
p Value Comment
P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
statistical Method
ANCOVA
ci Num Sides
TWO_SIDED
group Ids
OG002
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
ci Num Sides
TWO_SIDED
group Ids
OG003
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

categories
measurements
group Id
OG000
spread
0.528
value
-0.35
group Id
OG001
spread
0.524
value
-0.18
group Id
OG002
spread
0.459
value
-0.33
group Id
OG003
spread
0.497
value
-0.39
group Id
OG004
spread
0.406
value
-0.10
title
Week 12
categories
measurements
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
group Id
OG001
spread
0.505
value
-0.18
group Id
OG002
spread
0.506
value
-0.32
group Id
OG003
spread
0.529
value
-0.44
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
Week 24

denoms

counts
group Id
OG000
value
49
group Id
OG001
value
52
group Id
OG002
value
51
group Id
OG003
value
50
group Id
OG004
value
98
units
Participants

description

dispersion Type

Standard Deviation

groups

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
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
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
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
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 HAQ-DI 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 Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice