NCT01721044 · OUTCOME

Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib

A Moderate to Severe Rheumatoid Arthritis Study · Source last updated 2019-09-18

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

Measure: GEOMETRIC_MEAN
Unit: nanomoles*hour/Liter (nmol*h/L)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.

Analysis population: All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.

Groups in this outcome

Baricitinib 2 mg

Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm. Participants continued to take background cDMARD therapy throughout study.

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
Baricitinib 2 mg	185
Baricitinib 4 mg	210

Reported measurements

Source class 1

Values in nanomoles*hour/Liter (nmol*h/L) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Baricitinib 2 mg	615	43.1	Not reported	Not reported	Not reported
Baricitinib 4 mg	1140	38.7	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
43.1
value
615
group Id
OG001
spread
38.7
value
1140

denoms

counts
group Id
OG000
value
185
group Id
OG001
value
210
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group. Participants continued to take background cDMARD therapy throughout study.
id
OG000
title
Baricitinib 2 mg
description
Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm. Participants continued to take background cDMARD therapy throughout study.
id
OG001
title
Baricitinib 4 mg

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.

reporting Status

POSTED

time Frame

Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.

title

Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib

type

SECONDARY

unit Of Measure

nanomoles*hour/Liter (nmol*h/L)

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

Preserved source evidence · Not medical advice