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NCT02277444 · OUTCOME

Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy · Source last updated 2025-11-14

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

Measure
MEDIAN
Unit
micrograms*day/milliliter (mcg*day/mL)
Interval / dispersion
Full Range
Time frame
Week 28

What was measured

AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

Analysis population: The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.

Groups in this outcome

Golimumab

Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Golimumab127

Reported measurements

Source class 1
Values in micrograms*day/milliliter (mcg*day/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Golimumab399Not reported387424Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        387
        upper Limit
        424
        value
        399
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    units
    Participants
description
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
dispersion Type
Full Range
groups
  1. description
    Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
    id
    OG000
    title
    Golimumab
param Type
MEDIAN
population Description
The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
reporting Status
POSTED
time Frame
Week 28
title
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
type
PRIMARY
unit Of Measure
micrograms*day/milliliter (mcg*day/mL)

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

Preserved source evidence · Not medical advice