NCT01469013 · OUTCOME

PK: Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2019-09-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: nM
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Wks 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.

Analysis population: All participants who received any study drug and had evaluable Cmax data.

Groups in this outcome

1 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.

2 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.

4 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.

8 mg Baricitinib (LY3009104)

Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.

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 Baricitinib (LY3009104)	24
2 mg Baricitinib (LY3009104)	24
4 mg Baricitinib (LY3009104)	48
8 mg Baricitinib (LY3009104)	47

Reported measurements

Source class 1

Values in nM · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
1 mg Baricitinib (LY3009104)	35.7	20.9	Not reported	Not reported	Not reported
2 mg Baricitinib (LY3009104)	73.5	22.5	Not reported	Not reported	Not reported
4 mg Baricitinib (LY3009104)	147	20.6	Not reported	Not reported	Not reported
8 mg Baricitinib (LY3009104)	278	21.7	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
20.9
value
35.7
group Id
OG001
spread
22.5
value
73.5
group Id
OG002
spread
20.6
value
147
group Id
OG003
spread
21.7
value
278

denoms

counts
group Id
OG000
value
24
group Id
OG001
value
24
group Id
OG002
value
48
group Id
OG003
value
47
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
id
OG000
title
1 mg Baricitinib (LY3009104)
description
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
id
OG001
title
2 mg Baricitinib (LY3009104)
description
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
id
OG002
title
4 mg Baricitinib (LY3009104)
description
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
id
OG003
title
8 mg Baricitinib (LY3009104)

param Type

GEOMETRIC_MEAN

population Description

All participants who received any study drug and had evaluable Cmax data.

reporting Status

POSTED

time Frame

Wks 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.

title

PK: Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice