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NCT01721057 · OUTCOME

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

A Study in Moderate to Severe Rheumatoid Arthritis Participants · 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
nanogram per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose

Analysis population: All randomized participants who received at least 1 dose of study drug with evaluable PK data.

Groups in this outcome

Baricitinib 2 mg

Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg PO QD through week 24. Participants will continue 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

GroupSource count
Baricitinib 2 mg246
Baricitinib 4 mg245

Reported measurements

Source class 1
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Baricitinib 2 mg70.226.2Not reportedNot reportedNot reported
Baricitinib 4 mg13825.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.2
        value
        70.2
      2. group Id
        OG001
        spread
        25.7
        value
        138
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    2. group Id
      OG001
      value
      245
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
    id
    OG000
    title
    Baricitinib 2 mg
  2. description
    Baricitinib 4 mg PO QD through week 24. Participants will continue 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 with evaluable PK data.
reporting Status
POSTED
time Frame
Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose
title
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice