NCT01185353 · OUTCOME

Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128

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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Baseline through Weeks 76 and 128

What was measured

ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100.

Analysis population: All participants who received study drug in Parts C and D. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.

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 percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
4 mg LY3009104 QD - Parts C and D	29	Not reported	Not reported	Not reported	Not reported
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	18	Not reported	Not reported	Not reported	Not reported
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	25	Not reported	Not reported	Not reported	Not reported

Week 128 (n=79, 47, 18)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
4 mg LY3009104 QD - Parts C and D	28	Not reported	Not reported	Not reported	Not reported
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	17	Not reported	Not reported	Not reported	Not reported
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D	22	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
29
group Id
OG001
value
18
group Id
OG002
value
25
title
Week 76 (n=108, 61, 32)
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
17
group Id
OG002
value
22
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

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

NUMBER

population Description

All participants who received study drug in Parts C and D. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.

reporting Status

POSTED

time Frame

Baseline through Weeks 76 and 128

title

Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice