NCT01185353 · OUTCOME

Mean Change From Baseline to Weeks 76 and 128 in 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 76 and 128

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 participants who received study drug in Parts C and D and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.

Groups in this outcome

4 mg LY3009104 QD - Parts C and D

Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.

4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D

Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C. Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.

8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D

Received 8 mg LY3009104 QD in Parts A, B and C. Received 4 mg LY3009104 QD in Part D. 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
4 mg LY3009104 QD - Parts C and D	108
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	61
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	32

Reported measurements

Week 76 (n=108, 61, 32)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
4 mg LY3009104 QD - Parts C and D	-0.34	0.58	Not reported	Not reported	Not reported
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	-0.29	0.53	Not reported	Not reported	Not reported
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	-0.55	0.58	Not reported	Not reported	Not reported

Week 128 (n=79, 47, 18)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
4 mg LY3009104 QD - Parts C and D	-0.31	0.61	Not reported	Not reported	Not reported
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	-0.22	0.56	Not reported	Not reported	Not reported
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	-0.30	0.66	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.58
value
-0.34
group Id
OG001
spread
0.53
value
-0.29
group Id
OG002
spread
0.58
value
-0.55
title
Week 76 (n=108, 61, 32)
categories
measurements
group Id
OG000
spread
0.61
value
-0.31
group Id
OG001
spread
0.56
value
-0.22
group Id
OG002
spread
0.66
value
-0.30
title
Week 128 (n=79, 47, 18)

denoms

counts
group Id
OG000
value
108
group Id
OG001
value
61
group Id
OG002
value
32
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
id
OG000
title
4 mg LY3009104 QD - Parts C and D
description
Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C. Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
id
OG001
title
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
description
Received 8 mg LY3009104 QD in Parts A, B and C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
id
OG002
title
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D

param Type

MEAN

population Description

All participants who received study drug in Parts C and D 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 76 and 128

title

Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice