NCT01185353 · OUTCOME

Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)

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

Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.

Analysis population: All randomized participants who received study drug in Parts A and B and had DAS28-CRP 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	50
8 mg LY3009104	50
Placebo	93

Reported measurements

Week 12

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
1 mg LY3009104	-1.47	1.299	Not reported	Not reported	Not reported
2 mg LY3009104	-1.40	1.210	Not reported	Not reported	Not reported
4 mg LY3009104	-2.09	1.220	Not reported	Not reported	Not reported
8 mg LY3009104	-2.15	1.273	Not reported	Not reported	Not reported
Placebo	-0.98	1.141	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	-1.53	1.187	Not reported	Not reported	Not reported
4 mg LY3009104	-2.25	1.054	Not reported	Not reported	Not reported
8 mg LY3009104	-2.47	1.280	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
0.024
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
0.030
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
0.024
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
0.030
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
1.299
value
-1.47
group Id
OG001
spread
1.210
value
-1.40
group Id
OG002
spread
1.220
value
-2.09
group Id
OG003
spread
1.273
value
-2.15
group Id
OG004
spread
1.141
value
-0.98
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
1.187
value
-1.53
group Id
OG002
spread
1.054
value
-2.25
group Id
OG003
spread
1.280
value
-2.47
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
50
group Id
OG003
value
50
group Id
OG004
value
93
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 DAS28-CRP 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 Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice